Who We Are

The Alliance for Safe Biologic Medicines is an organization of patients, physicians, pharmacists, biotechnology companies that develop innovative and biosimilar medicines and others, who are working together to ensure that patient safety is at the forefront of the biosimilars policy discussion. It is the mission of the Alliance to serve as an authoritative resource center of information for the public, medical community, the FDA and other state and federal policymakers during the implementation of the biosimilars approval pathway and beyond.

Our Perspective

Biologics are advanced prescription drugs to treat cancer, rheumatoid arthritis and other debilitating diseases. In November 2010 the Food and Drug Administration began consultation with patient groups, physicians and industry on how to approve the first copies of these drugs, known as follow-on biologics or biosimilars. As the FDA moves forward in implementing this pathway, the Alliance for Safe Biologic Medicines will work to ensure patient safety remains the priority.

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.

ASBM Releases Fact Sheet on Emerging Challenges to Interchangeable Biosimilars Policy  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.

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