Posts – Page 3 – Safe Biologics

Biden Budget Would Allow Automatic Pharmacy Substitution of ALL Biosimilars, Misunderstands US and EU Substitution Policy

April 11, 2024

by Michael Reilly, ASBM Executive Director

The Biden Administration’s FY25 Budget, unveiled on March 11, 2024, takes aim at prescription drug costs but misses the mark and hurts rather than helps patients. Again. (Read my concerns with the Administration’s Medicare Part D price-setting system here).

This latest proposal would loosen the review criteria for some biologics and shift treatment decisions out of the hands of doctors. This proposal is built on a misunderstanding surrounding substitution of medicines and in particular the definition of the word “interchangeable” as it is used with biologic medicines.

These are very different in the US and Europe – similar to how asking for a torch in Europe will get you what we call a flashlight rather than an open flame.

This conceptual error is then used to argue for an inappropropriate expansion of automatic pharmacy-level substitution for all biosimilars- without prior FDA evaluation or physician approval, as current law requires.

The HHS Budget in Brief document describes the policy objective simply enough: “Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”.

Skipping over what that means, it justifies the policy by claiming “this change makes the U.S. biosimilar program more consistent with the approach adopted by other major regulatory jurisdictions such as the European Union where biosimilars are interchangeable with their respective reference products upon approval.”

First: in the U.S. and Europe alike, prescribers can already substitute any biosimilar for its reference product. What is at stake and where the two regions differ somewhat in policy is in when and how pharmacies can substitute biosimilars. The confusion stems from the fact that the term “interchangeable” has different meanings in the U.S. and Europe:

In Europe, “Interchangeable” means prescriber-substitutable.
The European Medicines Agency (EMA) has stated1all biosimilars it approves are “interchangeable” in that they “may be prescribed interchangeably” and that this does not refer to pharmacy substitution: “Member States will continue to decide…whether automatic substitution is allowed at the pharmacy level.”

European physicians (73%) strongly oppose substitution of biosimilars by someone other than the doctor for non-medical reasons (e.g. cost).2 Accordingly, this controversial practice is extremely rare in Western Europe and banned in many countries. Some resource-constrained Eastern European countries (e.g Latvia and Estonia) do permit it, however.

In the U.S., “Interchangeable” means pharmacy-substitutable.

In the U.S. “interchangeable” refers to a biosimilar which under state law may be substituted at the pharmacy level without physician approval because its manufacturer has provided additional data to the FDA demonstrating a patient can be switched between the biosimilar and reference product and expect the same result. Currently there are 8 biosimilars that can be substituted by the U.S. pharmacies in this manner, with more on the way.

Like their European counterparts, most U.S. physicians (58%) strongly oppose substitution of biosimilars by someone other than the doctor for non-medical reasons (e.g. cutting costs or increasing insurance company profits ).3 But this isn’t because physicians feel biosimilars are unsafe or ineffective; it’s because treatment plans aren’t one size fits all and many patients try several safe and effective products before they find one that best stabilizes the patient’s condition. Physicians don’t like to change medicines unnecessarily or inappropriately, and they believe the physician and the patient should make this decision, not the pharmacy or the insurance company.

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 reasons.
69% of US physicians surveyed consider it “very important or critical” that patients and physicians decide the most suitable biologic to use- be it the originator or one of the biosimilars to that product.

However, the extra data currently required to receive an “interchangeable” designation from the FDA increases physician confidence: most physicians (57%) are more comfortable prescribing an interchangeable, and with an interchangeable being substituted in place of the prescribed originator product (59%)3.

The Biden budget proposal would undermine this hard-won confidence by eliminating the FDA’s science-based data requirements for permitting pharmacy-substitution of biosimilars, and declaring by fiat that all biosimilars substitutable by the pharmacy, despite the opposition from U.S. physicians. And it does so based at least in part on a serious misunderstanding of what the health systems of other advanced countries permit.

ASBM Presents at World Health Organization’s 78th INN Consultation

March 21, 2024

On March 19th, ASBM presented to the World Health Organization International Nonpropretary Names (INN) Expert Group at the 78th 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. The proceedings of the INN Consultation are bound by confidentiality pending the publication of the Executive Summary by the WHO. However, the recently-released Executive Summary from the 77th INN Consulation (held October 19, 2023) lays out the benefits for a distinct nomenclature standard, and highlights the ongoing support for such a standard, both from ASBM as well as from regulators. From the Executive Summary:

The ASBM has supported the INN Group’s Biological Qualifier (BQ) scheme since its inception in 2012, and since then has doggedly presented data on the importance of a BQ to enhancing patient safety and pharmacovigilance (PV). However, they have also learned that WHO moves slowly, has many global health issues to deal with and has many stakeholders. Almost 10 years after the inception of the BQ, with no further action ensuing, a WHO report in 2021 highlighted that a lack of consistency in naming biosimilars had caused concern in prescribing, prescription mix-ups, unintended switching and traceability, and concluded that naming and labelling was important for product identification, PV and prescribing. 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. In the EU, the EMA has stated that it does not need a BQ as it has an alternative system in place but recognises the value of a unified system. Several arguments have been raised by stakeholders opposed to a BQ; however, in each case these have proven to be unfounded. For example, it had been stated that distinguishable names may imply inferior products, but this has not been the case in USA. In addition, surveys have shown that a supposed lack of support by physicians and global regulators was incorrect. 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. The ASBM made a proposal to quantify support for the BQ. . It acknowledged support for a BQ system and with the debate having continued for 10 years now it strongly encourage the WHO to take a leadership role. 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.

ASBM Releases Fact Sheet on Emerging Challenges to Interchangeable Biosimilars Policy

February 5, 2024

On January 31st, ASBM released a fact sheet describing a variety of proposed policy changes at the state and federal level which would weaken the interchangeable biosimilar standard, or circumvent the patient protections it provides. These include new bills and regulations at the federal level, as well as state legislation and proposals which threaten to undermine the hard-won gains of the patient and physician communities to ensure that only interchangeable biosimilars are substituted without physician approval.

Interchangeable Biosimilars: Emerging Policy Challenges

The fact sheet is the third in a series discussing interchangeable biosimilars and related policies. View the others below:

Physician Perspectives on Interchangeable Biosimilars

Interchangeable Biosimilars: Comparing Europe and the U.S.

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.