Posts – Page 3 – Safe Biologics

EMA Seeks Public Comment on Re-evaluating the Need for Clinical Safety and Efficacy Data in Biosimilar Development

February 1, 2024

On January 25, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) released a document entitled “Concept paper for the development of a Reflection Paper on a tailored clinical approach in Biosimilar development”.

The document expresses the EMA’s intent to streamline biosimilar development by re-evaluating the role of clinical safety and efficacy data; it also announces a three-month public consultation period running from February 1 to April 30, 2024. From the announcement:

Constantly striving for scientifically sound yet efficient processes, the Biosimilar regulatory framework has constantly been evolving towards increasingly tailored developments, starting from smaller and “simpler” biologics, such as recombinant Granulocyte-Colony Stimulating Factor (rG-CSF), insulins or somatropin where the need for comparative clinical efficacy trials is in general not required any more. With growing knowledge and the increasing possibilities of analytical and functional characterisation, revisiting the need for clinical efficacy trials for biosimilars (especially recombinant proteins and mAbs) is considered the next important step in order to keep the Biosimilar pathway attractive for developers and, at the same time, guarantee future access to safe and efficacious biologics for European patients.

The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability. When the biosimilar demonstrates a high degree of similarity to the RMP at the analytical and functional level, it may be possible to justify the omission of dedicated CES.

Comments may be submitted here until April 30, 2024.

Read the concept paper here.

GaBI Journal Publishes ASBM Whitepaper on Medicare Part D Price Setting

February 1, 2024

In January, the Generics and Biosimilars Initiative (GaBI) published a whitepaper entitled “Medicare Drug Price Negotiations: Impact on Healthcare Development and Patient Access to Medicines”. The paper’s content is drawn from a webinar on the same topic hosted by ASBM and GaBI on July 26, 2023. It examines the likely negative effects of IRA’s price negotiation provisions, which allow the Centers for Medicare and Medicaid Services to negotiate prices of certain costly drugs, including many biologic medicines.

The paper’s authors include three former government officials who worked on the development and implementation of Medicare Part D, the prescription drug benefit being modified by the IRA’s new price-setting provisions; as well as a prominent patient advocacy leader:

Michael S Reilly, Esq; Executive Director, ASBM
Thomas R Barker, Esq; Former Acting General Counsel of the US Department of Health and Human Services; Former Commissioner of the Medicaid and CHIP Payment and Access Commission (MACPAC)
Charles Clapton, Vice President, Federal Government Affairs, Gilead Sciences
Andrew Spiegel, Esq; Executive Director, Global Colon Cancer Association

The paper may be read online here; it will also be available in the print edition of GaBI Journal.

January 2024 Newsletter

February 1, 2024

EMA Seeks Public Comment on Re-evaluating the Need for Clinical Safety and Efficacy Data in Biosimilar Development
On January 25, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) released a document entitled “Concept paper for the development of a Reflection Paper on a tailored clinical approach in Biosimilar development”. The document expresses the EMA’s intent to streamline biosimilar development by re-evaluating the role of clinical safety and efficacy data; it also announces a three-month public consultation period running from February 1 to April 30, 2024. From the announcement: Constantly striving for scientifically sound yet efficient processes, the Biosimilar regulatory framework has constantly been evolving towards increasingly tailored developments, starting from smaller and “simpler” biologics, such as recombinant Granulocyte-Colony Stimulating Factor (rG-CSF), insulins or somatropin where the need for comparative clinical efficacy trials is in general not required any more. With growing knowledge and the increasing possibilities of analytical and functional characterisation, revisiting the need for clinical efficacy trials for biosimilars (especially recombinant proteins and mAbs) is considered the next important step in order to keep the Biosimilar pathway attractive for developers and, at the same time, guarantee future access to safe and efficacious biologics for European patients. The CHMP recognizes that there may be the potential to waive certain clinical data requirements even for complex biosimilars such as mAbs based on solid evidence of quality comparability. When the biosimilar demonstrates a high degree of similarity to the RMP at the analytical and functional level, it may be possible to justify the omission of dedicated CES. Comments may be submitted here until April 30, 2024. Read the concept paper here.

GaBI Journal Publishes ASBM Whitepaper on Medicare Part D Price Setting
In January, the Generics and Biosimilars Initiative (GaBI) published a whitepaper entitled “Medicare Drug Price Negotiations: Impact on Healthcare Development and Patient Access to Medicines”. The paper’s content is drawn from a webinar on the same topic hosted by ASBM and GaBI on July 26, 2023. It examines the likely negative effects of IRA’s price negotiation provisions, which allow the Centers for Medicare and Medicaid Services to negotiate prices of certain costly drugs, including many biologic medicines. The paper’s authors include three former government officials who worked on the development and implementation of Medicare Part D, the prescription drug benefit being modified by the IRA’s new price-setting provisions; as well as a prominent patient advocacy leader: Michael S Reilly, Esq; Executive Director, ASBMThomas R Barker, Esq; Former Acting General Counsel of the US Department of Health and Human Services; Former Commissioner of the Medicaid and CHIP Payment and Access Commission (MACPAC)Charles Clapton, Vice President, Federal Government Affairs, Gilead SciencesAndrew Spiegel, Esq; Executive Director, Global Colon Cancer AssociationThe paper may be read online here; it will also be available in the print edition of GaBI Journal.

ASBM Submits Comments on CMS Proposal to Allow Medicare Part D Plan Sponsors to Substitute Non-Interchangeable Biosimilars
On January 5th, ASBM submitted comments on a Centers for Medicare and Medicaid Services (CMS) Proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer. The Proposed Rule was announced in November 2023. ASBM’s statement on the announcement here. ASBM’s comments read, in part: Automatic substitution of biosimilars is highly controversial among physicians and is banned in many countries, including most of Europe. Proposing to change this standard in the U.S. not only undermines FDA regulatory guidance and the intent of the legislation passed by Congress and the entirety of our state legislatures, but also betrays the assurances given to patients, physicians, and other organizations who have supported the protections offered by biosimilar substitution laws nationwide. Beginning in 2013, all 50 states and Puerto Rico enacted legislation that allows for pharmacy-level, automatic substitution only for biosimilars given interchangeable status based on additional data provided to the FDA that demonstrates safe switching. Importantly, this legislation provided that all other biosimilars (i.e., those without an interchangeable status) would not be substituted at the pharmacy level without physician involvement or approval. State legislatures were able to gain support for permitting biosimilar substitution from medical societies and patient advocacy organizations nationwide, due to these assurances. While all FDA-approved biosimilars are safe and effective, the FDA’s concept of interchangeability ensures that switching decisions also account for the unique treatment needs of individual patients. Treatment plans are not one-size-fits-all. Chronic illnesses such as arthritis, Crohn’s disease, psoriasis, and various forms of cancer often require treatment plans tailored over years of trial and error with different products before a patient’s disease or condition is stabilized. Any change to a patient’s medication, including the automatic substitution of a biosimilar for the originator biologic without physician involvement, can pose a significant risk to patient stability.
The FDA’s interchangeability standard, with its extra data requirements, has proven successful in promoting physician and patient confidence in these medicines. A 2021 survey of US physicians representing 12 therapeutic areas revealed that 57% of them would be more likely to prescribe an interchangeable biosimilar, and 59% reported that an interchangeable designation makes them more comfortable with a pharmacy-level substitution of that biosimilar in place of the prescribed originator medicine. The dramatic change in policy proposed by CMS comes less than a year after a CMS Rule permitting Part D plan sponsors to substitute interchangeable biosimilars explicitly reassured the public it would not permit substitution of non-interchangeable biosimilars because they “have not met the requirements to support a demonstration of interchangeability.” Nothing has changed regarding non-interchangeable biosimilars since last year’s CMS Rule. Non-interchangeable biosimilars still haven’t met the FDA data requirements for interchangeability and still shouldn’t be substituted by a third party without physician approval. In summary, Section 8. Additional Changes to an Approved Formulary—Substituting Biosimilar Biological Products of the Proposed Rule stands in stark contrast to the opinions of the medical community, the wishes of patients, a decade of substitution policymaking across 50 states, the substitution policies of most advanced nations, and CMS’ own recent assurances. We respectfully urge CMS to reconsider and withdraw this rule. Read ASBM’s full comments on the proposed policy here.
Read ASBM’s statement on the announcement of the proposed policy here.

ASBM Featured in WHO Executive Summary of 77th INN Consultation
On January 18th, the World Health Organization published the Executive Summary of its 77th Consultation on International Non-proprietary Names for Pharmaceutical Substances (INN), held in Geneva, Switzerland on October 18th, 2023. ASBM was represented at the session by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP.In ASBM’s presentation, Schneider emphasized that in the decade since the INN Expert Group’s recommendation (that distinct suffixes be added to all biologics, including biosimilars) was made, it has not been withdrawn. Strong support for distinct naming still exists, as shown by several national regulatory authorities having adopted their own distinct naming systems. From the Executive Summary: When the BQ was first proposed, ASBM noted that several global regulatory agencies supported the scheme, including the US FDA which eventually adopted its own not dissimilar system comprising a random four-letter suffix. Other supporting agencies await the WHO implementing a global system. Over the years, the WHO has attempted to evaluate the BQ: a provisional implementation of the programme was suggested in 2016, and in 2017 a pilot BQ project was discussed. In 2018, the project was put on hold for data gathering. The ASBM would be interested in knowing the status of these approaches. Over these years also, the ASBM has surveyed and met with many global regulators and physicians and the vast majority support distinct nomenclature. The lack of action with the BQ has forced many regulators, either assigning the same non-proprietary name to biosimilars or in some cases to adopt their own system. However, most of them are willing to support a WHO system if it is implemented. Dr Balocco noted that the department had a new ADG and that WHO was soon to have a new Director-General. The WHO has been asked to work on a Global Substance Identifier (GSID) and there may be an opportunity to bring in the BQ as part of this. The INN Programme is in fact ready to implement a BQ. Dr Balocco expressed hope that a decision would be taken soon as the INN by itself is not sufficient for PV. Read the full Executive Summary of the 77th INN Consultation here.

IQVIA Institute Examines Infused Biosimilars Market in Medicare Part B
On January 24, the IQVIA Institute published a report entitled “Long-term Market Sustainability for Infused Biosimilars in the U.S.: Foundational Analytics on Emerging Risks to Sustainability” The report intends to create a base of foundational analytics to better understand the dynamics of biosimilars. The focus of this report is on infused biosimilars that fall under the buy and bill program in Medicare Part B. In particular, the aim is to understand the key issues that can lead to the sub-optimal functioning of the biosimilars market in the U.S. by analyzing various case studies. The report highlighted the success of biosimilar competition in lowering Average Sales Price (ASP), as well as the role of payer policies (e.g. rebate walls and lack of transparency in formulary design) in limiting biosimilar uptake. Among the report’s key findings:Overall, across all biosimilar markets, ASPs generally decline by an average of 50% within the first 12 quarters on market.In the current set-up, biosimilars enter a cycle where they are consistently increasing stakeholder rebate/discounts to remain competitive, which results in regular ASP reductions each quarter.While in the case of several oncology biosimilars the biosimilar manufacturers have managed to gain share, uptake has been slow in the case of infliximab and pegfilgrastim.The example of infliximab has been noted to potentially highlight a dynamic where rebate walls were one of the reasons that drove the slow uptake.In the initial period, the uptake of biosimilars was extremely limited, with most commercial plans preferring the originator on their formulary. This dynamic has been noted as being driven by rebating, however a lack of transparency around rebating makes it hard to ascertain the exact dynamics that took place.After four years, some of the biosimilars began to achieve improved formulary status on commercial plans and the overall uptake began to increase.Read the full report here.

Missed last month’s ASBM Newsletter?Read it here.

UPCOMING EVENTS WHO 78th INN ConsultationGeneva, Switzerland – March 19, 2024 ASCO Annual MeetingChicago, IL – May 31-June 4, 2024 BIO International Meeting
San Diego, CA – June 3-6, 2024 DIA Global Annual Meeting
San Diego, CA – June 16-20, 2024

December 2023 Newsletter

January 12, 2024

ASBM Records Podcast on Inflation Reduction Act’s Medicare Drug Price Setting In December, ASBM and its member organization AI Arthritis recorded an episode of the AiArthritis 360 Voices podcast examining how the IRA’s changes to the popular and highly successful Medicare Part D prescription drug benefit will negatively impact patients in coming years. The episode was released December 27th.
The episode features three former government officials who worked on the development and implementation of Medicare Part D as well as two leading patient advocates. Participants discussed how the price-setting policy will result in fewer drugs being developed, reduced patient access to these medicines, and will likely fail to control costs as its proponents claim. Speakers included:
Thomas R Barker, Esq;Former Acting General Counsel of the US Department of Health and Human Services; Former Commissioner of the Medicaid and CHIP Payment and Access Commission (MACPAC) Charles ClaptonVice President, Federal Government Affairs, Gilead Sciences, former Health Policy Director for the Senate HELP Committee and Former Chief Counsel for the House Ways and Means and Energy and Commerce Committees. Michael S Reilly, Esq Executive Director, Alliance for Safe Biologic Medicines, former Associate Deputy Secretary, U.S. Department of Health and Human Services Tiffany Westrich-RobertsonCEO at the International Foundation for Autoimmune & Autoinflammatory Arthritis (AiArthritis) Andrew Spiegel, EsqExecutive Director, Global Colon Cancer Association; ASBM Steering Committee Member Listen to audio of the podcast here. View video of the podcast here.

ASBM Submits Comments to Oregon PDAB Opposing Proposal to Permit Automatic Substitution of Non-Interchangeable Biosimilars

On December 13, Oregon’s Prescription Drug Affordability Board (PDAB) met to consider – and ultimately rejected – a proposal to permit the automatic substitution of non-interchangeable biosimilars; that is, their substitution at the pharmacy level without prescriber involvement. The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe. Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted. These have provided additional data demonstrating that safety and effectiveness do not diminish even after a patient is switched repeatedly between the reference product and the interchangeable biosimilar. Current law also requires pharmacies to inform patients if their medicine is being switched, but the proposed change would have eliminated this requirement. ASBM submitted comments opposing the proposal and defending the current state law. From the comments: As Congress and the FDA intended, the interchangeable biosimilar designation has proven successful in promoting confidence in biosimilars, and in their automatic and third-party substitution: 57% of physicians said they’d be more likely to prescribe an interchangeable biosimilar; 59% said that an interchangeability designation makes them more comfortable with a pharmacy-level substitution of a biosimilar in place of the originator. States like Oregon were able to gain physician support for their biosimilar substitution legislation due to the assurances provided in the legislation that only interchangeable biosimilars would be substituted without prescriber approval. They were able to secure support from patient advocacy organizations conditional on patients being notified if their medicine were to be switched. The proposal under consideration by the PDAB strikes at the heart of these reasonable protections, and betrays the promises made to physicians and patients. Read ASBM’s full comments to the Oregon PDAB here.

Comment Period Closes on CMS Proposal to Allow Medicare Part D Plan Sponsors to Substitute Non-Interchangeable Biosimilars In November, the Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer. Read ASBM’s statement on the announcement here. CMS accepted public comments on the Proposed Rule until January 5, 2024. ASBM was among the organizations which submitted comments. ASBM’s comments read, in part: Automatic substitution of biosimilars is highly controversial among physicians and is banned in many countries, including most of Europe. Proposing to change this standard in the U.S. not only undermines FDA regulatory guidance and the intent of the legislation passed by Congress and the entirety of our state legislatures, but also betrays the assurances given to patients, physicians, and other organizations who have supported the protections offered by biosimilar substitution laws nationwide. Beginning in 2013, all 50 states and Puerto Rico enacted legislation that allows for pharmacy-level, automatic substitution only for biosimilars given interchangeable status based on additional data provided to the FDA that demonstrates safe switching. Importantly, this legislation provided that all other biosimilars (i.e., those without an interchangeable status) would not be substituted at the pharmacy level without physician involvement or approval. State legislatures were able to gain support for permitting biosimilar substitution from medical societies and patient advocacy organizations nationwide, due to these assurances. While all FDA-approved biosimilars are safe and effective, the FDA’s concept of interchangeability ensures that switching decisions also account for the unique treatment needs of individual patients. Treatment plans are not one-size-fits-all. Chronic illnesses such as arthritis, Crohn’s disease, psoriasis, and various forms of cancer often require treatment plans tailored over years of trial and error with different products before a patient’s disease or condition is stabilized. Any change to a patient’s medication, including the automatic substitution of a biosimilar for the originator biologic without physician involvement, can pose a significant risk to patient stability.
The FDA’s interchangeability standard, with its extra data requirements, has proven successful in promoting physician and patient confidence in these medicines. A 2021 survey of US physicians representing 12 therapeutic areas revealed that 57% of them would be more likely to prescribe an interchangeable biosimilar, and 59% reported that an interchangeable designation makes them more comfortable with a pharmacy-level substitution of that biosimilar in place of the prescribed originator medicine. The dramatic change in policy proposed by CMS comes less than a year after a CMS Rule permitting Part D plan sponsors to substitute interchangeable biosimilars explicitly reassured the public it would not permit substitution of non-interchangeable biosimilars because they “have not met the requirements to support a demonstration of interchangeability.” Nothing has changed regarding non-interchangeable biosimilars since last year’s CMS Rule. Non-interchangeable biosimilars still haven’t met the FDA data requirements for interchangeability and still shouldn’t be substituted by a third party without physician approval. In summary, Section 8. Additional Changes to an Approved Formulary—Substituting Biosimilar Biological Products of the Proposed Rule stands in stark contrast to the opinions of the medical community, the wishes of patients, a decade of substitution policymaking across 50 states, the substitution policies of most advanced nations, and CMS’ own recent assurances. We respectfully urge CMS to reconsider and withdraw this rule. Read ASBM’s full comments on the proposed policy here.
Read ASBM’s statement on the announcement of the proposed policy here.

Coming in January: ASBM Whitepaper on Negative Impacts of Medicare Part D Price Setting In January, the Generics and Biosimilars Initiative (GaBI) will publish a whitepaper entitled Medicare Drug Price Negotiations: Impact on Healthcare Development and Patient Access to Medicines.
The paper examines the likely negative effects of IRA’s price negotiation provisions, which allow the Centers for Medicare and Medicaid Services to negotiate prices of certain costly drugs, including many biologic medicines. The paper’s content is drawn from a webinar on the same topic hosted by ASBM and GaBI on July 26, 2023.
The paper’s authors include three former government officials worked on the development and implementation of Medicare Part D, the prescription drug benefit which is being modified by the IRA’s new price-setting provisions; as well as a prominent patient advocacy leader: Michael S Reilly, Esq; Executive Director, ASBMThomas R Barker, Esq; Former Acting General Counsel of the US Department of Health and Human Services; Former Commissioner of the Medicaid and CHIP Payment and Access Commission (MACPAC)Charles Clapton, Vice President, Federal Government Affairs, Gilead SciencesAndrew Spiegel, Esq; Executive Director, Global Colon Cancer AssociationThe paper will be both published online and in the print edition of GaBI Journal.

How Inflation Reduction Act’s Price Setting Discourage Biosimilar Development and Reduce Price Competition
On December 15, the legal analysis site JD Supra published an article entitled “The Inflation Reduction Act’s First Potential Impact on Biosimilars”. The article examines the recent FDA approval of Amgen’s Wezlana (ustekinumab-auub) as an interchangeable biosimilar to Janssen’s Stelara (ustekinumab). Stelara was recently selected by the Center for Medicare & Medicaid Services (“CMS”) as one of the first 10 drugs subject to the Inflation Reduction Act’s (“IRA’s”) price negotiations. While the effects of price-setting on the development of new innovator biologics have been widely discussed, the article outlines how price setting for an originator biologic can also also discourage the development of biosimilars to these products: Because of price caps that the IRA will impose on Stelara, Wezlana will face a different competitive landscape than the six interchangeables for other drugs approved to date. Wezlana’s example calls into question whether the IRA will disincentivize the development of biosimilars for the most popular biologics at a time when more biosimilars are critical to reducing healthcare costs. The [Maximum Fair Price] imposed on Stelara during this time period will impact Wezlana’s profitability. Amgen presumably will offer Wezlana at a discount relative to Stelara. But in order to undercut Stelara’s MFP-capped price, Amgen will have to price Wezlana substantially lower than it would have if CMS had not selected Stelara. Getting more biosimilars on the market is widely viewed as critical to controlling the costs of biologics. HHS has reported pre-IRA price drops of up to 71% and 53% for biosimilars and their reference products, respectively. But the prospect of a reference drug being selected under the IRA could discourage drug companies from developing biosimilars to that reference drug. If that comes to pass, consumers will end up paying more for biologics over the long term. Read the full JD Supra article here.

Missed last month’s ASBM Newsletter?Read it here.

UPCOMING EVENTS WHO 78th INN ConsultationGeneva, Switzerland – March 19, 2024 ASCO Annual MeetingChicago, IL – May 31-June 4, 2024 DIA Global Annual Meeting
San Diego, CA – June 16-20, 2024

ASBM Submits Comments Opposing CMS Proposal to Permit Medicare Part D Plans to Substitute Non-Interchangeable Biosimilars

January 6, 2024

In November, the Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer. Read ASBM’s statement on the announcement here.

CMS accepted public comments on the Proposed Rule until January 5, 2024. ASBM was among the organizations which submitted comments. ASBM’s comments read, in part:

Automatic substitution of biosimilars is highly controversial among physicians and is banned in many countries, including most of Europe. Proposing to change this standard in the U.S. not only undermines FDA regulatory guidance and the intent of the legislation passed by Congress and the entirety of our state legislatures, but also betrays the assurances given to patients, physicians, and other organizations who have supported the protections offered by biosimilar substitution laws nationwide.

Beginning in 2013, all 50 states and Puerto Rico enacted legislation that allows for pharmacy-level, automatic substitution only for biosimilars given interchangeable status based on additional data provided to the FDA that demonstrates safe switching. Importantly, this legislation provided that all other biosimilars (i.e., those without an interchangeable status) would not be substituted at the pharmacy level without physician involvement or approval. State legislatures were able to gain support for permitting biosimilar substitution from medical societies and patient advocacy organizations nationwide, due to these assurances.

While all FDA-approved biosimilars are safe and effective, the FDA’s concept of interchangeability ensures that switching decisions also account for the unique treatment needs of individual patients. Treatment plans are not one-size-fits-all. Chronic illnesses such as arthritis, Crohn’s disease, psoriasis, and various forms of cancer often require treatment plans tailored over years of trial and error with different products before a patient’s disease or condition is stabilized. Any change to a patient’s medication, including the automatic substitution of a biosimilar for the originator biologic without physician involvement, can pose a significant risk to patient stability.

The FDA’s interchangeability standard, with its extra data requirements, has proven successful in promoting physician and patient confidence in these medicines. A 2021 survey of US physicians representing 12 therapeutic areas revealed that 57% of them would be more likely to prescribe an interchangeable biosimilar, and 59% reported that an interchangeable designation makes them more comfortable with a pharmacy-level substitution of that biosimilar in place of the prescribed originator medicine.

The dramatic change in policy proposed by CMS comes less than a year after a CMS Rule[v] permitting Part D plan sponsors to substitute interchangeable biosimilars explicitly reassured the public it would not permit substitution of non-interchangeable biosimilars because they “have not met the requirements to support a demonstration of interchangeability.” Nothing has changed regarding non-interchangeable biosimilars since last year’s CMS Rule. Non-interchangeable biosimilars still haven’t met the FDA data requirements for interchangeability and still shouldn’t be substituted by a third party without physician approval.

In summary, Section 8. Additional Changes to an Approved Formulary—Substituting Biosimilar Biological Products of the Proposed Rule stands in stark contrast to the opinions of the medical community, the wishes of patients, a decade of substitution policymaking across 50 states, the substitution policies of most advanced nations, and CMS’ own recent assurances. We respectfully urge CMS to reconsider and withdraw this rule.

Read ASBM’s full comments on the proposed policy here.

Read ASBM’s statement on the announcement of the proposed policy here.

ASBM Submits Comments to Oregon PDAB Opposing Proposal to Permit Automatic Substitution of Non-Interchangeable Biosimilars

December 20, 2023

On December 13, Oregon’s Prescription Drug Affordability Board (PDAB) met to consider – and ultimately rejected – a proposal to permit the automatic substitution of non-interchangeable biosimilars; that is, the substitution at the pharmacy level of a biosimilar without prescriber involvement. The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe.

Oregon state law currently only permits biosimilars that the FDA has approved as interchangeable to be automatically substituted. These have provided additional data demonstrating that safety and effectiveness do not diminish even after a patient is switched from the reference product to the interchangeable.

ASBM submitted comments opposing the proposal and defending the current state law. From the comments:

As Congress and the FDA intended, the interchangeable biosimilar designation has proven successful in promoting confidence in biosimilars, and in their automatic and third-party substitution: 57% of physicians said they’d be more likely to prescribe an interchangeable biosimilar; 59% said that an interchangeability designation makes them more comfortable with a pharmacy-level substitution of a biosimilar in place of the originator.

States like Oregon were able to gain physician support for their biosimilar substitution legislation due to the assurances provided in the legislation that only interchangeable biosimilars would be substituted without prescriber approval. They were able to secure support from patient advocacy organizations conditional on patients being notified if their medicine were to be switched. The proposal under consideration by the PDAB strikes at the heart of these reasonable protections, and betrays the promises made to physicians and patients.

Read the full PDAB comments here.

ASBM Comments on FDA Draft Guidance Removing Interchangeability Statement from Interchangeable Biosimilars

December 19, 2023

On November 17th, ASBM submitted comments to the Food and Drug Administration (FDA) on draft guidance released in September by the FDA. The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. Under U.S. state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber. This is due to their having provided additional data to the FDA demonstrating that the safety and efficacy aren’t diminished even after repeated switching with the original biologic. The agency has approved 44 biosimilar products, including seven interchangeable biosimilars. From the comments:

ASBM respectfully disagrees that the interchangeability statement is not valued by prescribing health care professionals. In a survey of 400 US physicians who prescribe biologics, participants were asked how important it is that the product label clearly indicates that a biosimilar is or is not interchangeable; approximately 80% of physicians rated the importance of this either a 4 or 5 on a 5-point scale. Likewise, a survey of over 400 pharmacists indicated that almost 90% of those polled rated the importance of the product label clearly indicating that a biosimilar is or is not interchangeable as a 4 or 5 on a 5-point scale. ASBM believes FDA’s interchangeability standard, with its extra data requirements, has proven successful in promoting physician and patient confidence in these medicines. A 2021 survey of US physicians representing 12 therapeutic areas revealed that 57% of them would be more likely to prescribe an interchangeable biosimilar, and 59% reported that an interchangeable designation makes them more comfortable with a pharmacy- level substitution of that biosimilar in place of the prescribed originator. Only a third of physicians surveyed indicated that an interchangeable designation would not affect their prescribing behaviors.

Read the new FDA Guidance here.
Read ASBM’s comments on the guidance here.

ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars

December 8, 2023

On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted Interchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars. The webinar was the fourth in a series covering key health policy issues. The most recent of the webinars, hosted July 29th, examined the negative impact of the Inflation Reducation Act’s Medicare drug price setting provisions.

Key topics of discussion included:
The importance of the interchangeable designation in building physician confidence in the prescribing and pharmacy substitution of biosimilars

The collaborative efforts by patients, physicians, pharmacists, and other stakeholders nationwide over eight years permitting the automatic substitution of biosimilars, providing they were approved as interchangeable.

The difference between the definitions of interchangeability in Europe and in the U.S.
Current legislative and administrative proposals that would weaken the interchangeable designation or eliminate it entirely.

Speakers included:

Michael Reilly, Esq. – Executive Director, ASBM

Ralph McKibbin, MD, FACP, FACG, AGAF – ASBM Chairman

Philip Schneider, MS, FASHP, FFIP – ASBM Advisory Board Chair

Andrew Spiegel, Esq. – Executive Director, Global Colon Cancer Association

Steven Stranne, MD, JD- Partner, Foley Hoag LLP served as moderator of the discussion.

View a recording of the webinar here.

October 2023 Newsletter

December 6, 2023

ASBM Statement: In Shocking Reversal, CMS Wants to Allow Medicare Part D Plan Sponsors to Substitute Non-Interchangeable Biosimilars
On November 6, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer. The policy change represents a stark departure from the perspectives of the U.S. medical community and patient advocacy organizations, a decade of state-level policymaking, and CMS’ recent assurances, warns the Alliance for Safe Biologic Medicines. “Substitution of biosimilars by someone other than the prescribing physician is a controversial practice banned in many countries, including nearly all of Western Europe”, says ASBM Executive Director Michael Reilly, who served as Associate Deputy Secretary of Health and Services during the development and implementation of the Part D prescription drug benefit. “It is also opposed by the majority of physicians, in the U.S. and worldwide.” A 2021 survey of 401 U.S physicians found that while 89% of U.S. prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. cost, coverage) reasons- as would occur under the proposed CMS rule. Further, 69% consider it very important or critical that physicians, with their patient, make these treatment decisions. “Treatment plans aren’t one-size fits all”, explains ASBM Chairman and practicing gastroenterologist Ralph McKibbin, MD, FACP, FACG, AGAF. “Patients often try several products over years before finding the one that best stabilizes their condition. As doctors and patients, we’re reluctant to switch a patient’s medicine unnecessarily and risk losing those gains.” U.S. state laws nationwide permit pharmacy-level substitution of “interchangeable biosimilars”- those for which the manufacturer has provided additional safety and efficacy data to the FDA showing that a patient who’s been switched to the interchangeable product will have the same results as staying on the originator product. These laws were passed state by state over the past decade with the support of physician societies and patient advocacy organizations- contingent on assurances that only interchangeable biosimilars would ever be substituted without physician approval. Read the full statement here.

REMINDER: FDA Draft Guidance Would Remove Interchangeability Statement from Interchangeable Biosimilars
Comments Due November 17th On September 15th, the Food and Drug Administration (FDA) released draft guidance removing the interchangeability statement from the product label/package insert. Under U.S. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber. This is due to their having provided additional data to the FDA, demonstrating that the same result can be expected even after repeated switching with the original biologic.The agency has approved 42 biosimilar products, including four interchangeable biosimilars.  ASBM surveys of U.S. physicians (n=400) and pharmacists (n=401) revealed the value of the interchangeability statement to healthcare providers, with 85% of physicians and 88% of pharmacists rating this information (a statement of whether or not a biosimilar is interchangeable with its reference product) as highly important to appear in the product label/package insert.
A 2021 ASBM multi-specialty physician survey (n=401) revealed the value of the interchangeable designation to prescribers specifically:57% said a biosimilar carrying an interchangeable designation would make them more likely to prescribe it.
59% said that an interchangeability designation makes them more comfortable with a pharmacy-level substitution of a biosimilar in place of the originator.The FDA will be accepting comments on the draft guidance through Nov. 17th. Comments may be submitted here.  ASBM and its member organizations intend to submit comments opposing this move and emphasizing the value this information provides to patients and physicians. Read the new FDA Guidance here.
Submit comments on the guidance here.

ASBM to Exhibit at ACR Convergence 2023

Visit ASBM at Booth #2612 at ACR Convergence in San Diego, CA, November 12-14th. Learn about ASBM’s recent educational activities surrounding IRA Medicare drug price negotiation, interchangeable biosimilars, and other key policy issues affecting patient access to medicines. Exhibit hours will be:
Sunday, November 12th 10am-5pmMonday, November 13th 10am-5pmTuesday, November 14th 10am-2:30pm

ASBM Presents at WHO’s 77th INN Consultation
On October 18th, ASBM participated in the World Health Organization’s 77th Consultation on International Non-proprietary Names (INN) for Pharmaceutical Substances, held in Geneva, Switzerland. This was the twenty-first INN Consultation in which ASBM has participated. ASBM was represented at the session by Executive Director Michael Reilly, Esq., and Advisory Board Chair Philip Schneider, MS, FASHP. The proceedings at the Consultation are bound by confidentiality pending the WHO’s publication of the Executive Summary. ASBM will share the Executive Summary when it is published in the coming months. Read the WHO’s summary of the 76th INN Consultation here.

FDA Approves Interchangeable Biosimilar for Ustekinumab
On October 31st, the U.S. Food and Drug Administration (FDA) approved Wezlana (ustekinumab-auub) as an interchangeable biosimilar with Stelara (ustekinumab) for multiple inflammatory diseases. Wezlana is approved to treat adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; and moderately to severely active ulcerative colitis. It is also approved to treat pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and active psoriatic arthritis. Under U.S. state law, only interchangeable biosimilars are substitutable at the pharmacy without physician involvement- referred to as “automatic substitution”, due to their having provided additional safety and efficacy data to the FDA demonstrating the same effects can be expected even after repeated switches between biosimilar and reference product. Yet there have been recent efforts to undermine or weaken the interchangeability standard, including S.6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable”. In a letter to Senator Mike Lee (R-UT) dated September 27, ASBM urged the Senator to reconsider his support for the bill. In the letter, ASBM Executive Director Michael Reilly stresses the importance of this data to physicians: Physicians and patients worldwide value data, including switching studies. Surveys of Canadian physicians found that 82% wanted switching studies before automatic substitution was permitted. The figure was nearly identical, 81%, when I shared Australian physician survey findings with officials in their Department of Health, who expressed admiration for the FDA’s interchangeability standard in providing such assurances.
However, S.6 would prevent the HHS Secretary from requiring a switching study as part of the data package to receive the interchangeable designation. This would inappropriately limit the FDA’s authority to determine what data is scientifically appropriate for a particular biosimilar to provide in order to receive the designation. The FDA has thus far exercised its flexibility in making these determinations and should be allowed to continue to do so.The interchangeable designation has not only boosted physician and patient confidence, it has done so without becoming a barrier to biosimilar uptake and savings. Read the full letter here.

ASBM Chairman Receives New Faculty Appointment
In October, ASBM Chairman Ralph McKibbin, MD, FACP, FACG, AGAF received the appointment of Clinical Assistant Professor of Gastroenterology at the Duquesne University College of Osteopathic Medicine in Pittsburgh, PA. The College trains physicians to care for all people in all communities, including underserved urban and rural communities of Western Pennsylvania, the nation and the world, addressing healthcare disparities among the communities. Dr. McKibbin will continue in his current clinical duties at University of Pittsburgh Medical Center Altoona, PA.

ASBM to Present at World Drug Safety Congress Americas 2023

On October 19th, ASBM Advisory Board Chair Philip Schneider presented at the World Drug Safety Congress Americas 2023 in Boston, Massachusetts. Dr. Schneider’s presentation is entitled “Preventability and Severity Assessment in Reporting Adverse Drug Reactions: Balancing Effectiveness, Safety and the Responsible Use of Limited Healthcare Resources”. Read the presentation here. The World Drug Safety Congress Americas will bring together more than 1,300 top leaders and stakeholders in biopharma to discuss the key challenges they are facing in pharmacovigilance and device safety. Participants will explore strategies in data management & signal detection, showcase how AI & machine learning have improved PV processes, and discuss the challenges creating a PV strategy for advanced therapies.

Manufacturer Pauses Rare Cancer Research Due to IRA In October, Relay Therapeutics announced plans to shift away from treating a rare cancer and switch focus to the larger tumor-agnostic market. The Boston-based biotech is pointing to the Inflation Reduction Act as a driving factor of its decision. As reported in BioSpace October 13th: Relay’s FGFR2 inhibitor has been engaged in a Phase I/II trial since August 2020 for patients with unresectable or metastatic cholangiocarcinoma (CCA). Considered rare, an estimated 8,000 people in the U.S. are diagnosed each year with CCA, or bile duct cancer, with only around 1,000 individuals having the FGFR2-fusion. Due to the impacts of the Inflation Reduction Act (IRA) signed into law in August 2022, Relay is switching gears to focus lirafugratinib in patients with FGFR2-altered solid tumors, a population for which the biotech estimates a much higher 20,000 a year diagnosed in the U.S. Relay’s move is in line with what some experts expected might happen after the IRA was signed into law. BioSpace previously reported Meenakshi Datta, a partner at Chicago-based law firm Sidley Austin, argued that the IRA might also adversely affect orphan drug development. Read the full BioSpace article here. A recent ASBM webinar examining the IRA’s likely effects on drug development and patient access also concluded the law will result in reduced rare disease and cancer research. Watch clips from the webinar here.

Missed last month’s ASBM Newsletter?Read it here.

UPCOMING EVENTS ACR Convergence 2023
San Diego, CA – November 10-15, 2023 WHO 78th INN ConsultationGeneva, Switzerland – March 19, 2024 ASCO Annual MeetingChicago, IL – May 31-June 4, 2024

November 2023 Newsletter

December 3, 2023

ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted Interchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars. The webinar was the fourth in a series covering key health policy issues. The most recent of the webinars, hosted July 29th, examined the negative impact of the Inflation Reducation Act’s Medicare drug price setting provisions.
Key topics of discussion included:The importance of the interchangeable designation in building physician confidence in the prescribing and pharmacy substitution of biosimilars
The collaborative efforts by patients, physicians, pharmacists, and other stakeholders nationwide over eight years permitting the automatic substitution of biosimilars, providing they were approved as interchangeable.
The difference between the definitions of interchangeability in Europe and in the U.S.
Current legislative and administrative proposals that would weaken the interchangeable designation or eliminate it entirely.
Speakers included:Michael Reilly, Esq. – Executive Director, ASBMRalph McKibbin, MD, FACP, FACG, AGAF – ASBM ChairmanPhilip Schneider, MS, FASHP, FFIP – ASBM Advisory Board ChairAndrew Spiegel, Esq. – Executive Director, Global Colon Cancer AssociationSteven Stranne, MD, JD- Partner, Foley Hoag LLP served as moderator of the discussion. View a recording of the webinar here.

Oregon PDAB Accepting Comments on Proposal to Permit Automatic Substitution of Non-Interchangeable Biosimilars

On December 13, Oregon’s Prescription Drug Affordability Board (PDAB) will consider a proposal to permit the automatic substitution of non-interchangeable biosimilars- that is, the substitution at the pharmacy level of a biosimilar without prescriber involvement. The automatic substitution of biosimilars is a controversial practice, banned in many countries including nearly all of Western Europe. Oregon state law currently permits biosimilars that the FDA has approved as interchangeable to be automatically substituted. These have provided additional data demonstrating that safety and effectiveness do not diminish even after a patient is switched from the reference product to the interchangeable. U.S. laws permitting biosimilar substitution of interchangeables were developed over an 8-year period based on input from patient advocacy organizations, state medical societies, and state pharmacy societies. The support of these stakeholders for biosimilar substitution was conditional on requirements that only interchangeable biosimilars would be substituted and that the physician and patient would be notified of any switch. The proposal under consideration would completely remove these provisions, meaning insurers and pharmacy benefit managers could automatically substitute a biosimilar without patient physician or knowledge. Comments on the proposal may be submitted in a public comment form here or emailed to pdab@dcbs.oregon.gov

ASBM Comments on FDA Draft Guidance Removing Interchangeability Statement from Interchangeable Biosimilars On November 17th, ASBM submitted comments to the Food and Drug Administration (FDA) on draft guidance released in September by the FDA. The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. Under U.S. state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber. This is due to their having provided additional data to the FDA demonstrating that the safety and efficacy aren’t diminished even after repeated switching with the original biologic. The agency has approved 44 biosimilar products, including seven interchangeable biosimilars. From the comments: ASBM respectfully disagrees that the interchangeability statement is not valued by prescribing health care professionals. In a survey of 400 US physicians who prescribe biologics, participants were asked how important it is that the product label clearly indicates that a biosimilar is or is not interchangeable; approximately 80% of physicians rated the importance of this either a 4 or 5 on a 5-point scale. Likewise, a survey of over 400 pharmacists indicated that almost 90% of those polled rated the importance of the product label clearly indicating that a biosimilar is or is not interchangeable as a 4 or 5 on a 5-point scale. ASBM believes FDA’s interchangeability standard, with its extra data requirements, has proven successful in promoting physician and patient confidence in these medicines. A 2021 survey of US physicians representing 12 therapeutic areas revealed that 57% of them would be more likely to prescribe an interchangeable biosimilar, and 59% reported that an interchangeable designation makes them more comfortable with a pharmacy- level substitution of that biosimilar in place of the prescribed originator. Only a third of physicians surveyed indicated that an interchangeable designation would not affect their prescribing behaviors. Read the new FDA Guidance here.
Read ASBM’s comments on the guidance here.

ASBM Releases Statement on CMS Proposal to Allow Medicare Part D Plan Sponsors to Substitute Non-Interchangeable Biosimilars
Update: Comments Due January 5, 2024 On November 6, 2023, the Centers for Medicare and Medicaid Services (CMS) announced a proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer. The policy change represents a stark departure from the perspectives of the U.S. medical community and patient advocacy organizations, a decade of state-level policymaking, and CMS’ recent assurances, according to the Alliance for Safe Biologic Medicines. “Substitution of biosimilars by someone other than the prescribing physician is a controversial practice banned in many countries, including nearly all of Western Europe”, says ASBM Executive Director Michael Reilly, who served as Associate Deputy Secretary of Health and Services during the development and implementation of the Part D prescription drug benefit. “It is also opposed by the majority of physicians, in the U.S. and worldwide.” A 2021 survey of 401 U.S physicians found that while 89% of U.S. prescribers have high confidence in the safety and efficacy of biosimilars, a majority (58%) oppose third-party switching of a patient’s biologic medicine for non-medical (e.g. cost, coverage) reasons- as would occur under the proposed CMS rule. Further, 69% consider it very important or critical that physicians, with their patient, make these treatment decisions. “Treatment plans aren’t one-size fits all”, explains ASBM Chairman and practicing gastroenterologist Ralph McKibbin, MD, FACP, FACG, AGAF. “Patients often try several products over years before finding the one that best stabilizes their condition. As doctors and patients, we’re reluctant to switch a patient’s medicine unnecessarily and risk losing those gains.” U.S. state laws nationwide permit pharmacy-level substitution of “interchangeable biosimilars”- those for which the manufacturer has provided additional safety and efficacy data to the FDA showing that a patient who’s been switched to the interchangeable product will have the same results as staying on the originator product. These laws were passed state by state over the past decade with the support of physician societies and patient advocacy organizations- contingent on assurances that only interchangeable biosimilars would ever be substituted without physician approval. CMS is accepting public comments on the Proposed Rule. They may be submitted here and are due by January 5, 2024 Read the full statement here.

ASBM Exhibits at ACR Convergence 2023

From November 12-14, ASBM exhibited at Booth #2612 at ACR Convergence 2023 in San Diego, CA. ACR Convergence is hosted annually by the American College of Rheumatology and is considered the premier meeting for rheumatology professionals globally. ASBM was represented at the booth by Executive Director Michael Reilly, Advisory Board Chair Philip Schneider, and Programs Director Ray Patnaude. Visitors to the booth learned about ASBM’s recent educational activities surrounding IRA Medicare drug price negotiation, interchangeable biosimilars, and other key policy issues affecting patient access to medicines. Learn more about ACR Convergence 2023 here.