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.

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