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.
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 Whitepaper to Examine Impact of Medicare Drug Price-Setting on Drug Development, Patient Access|
The Journal of the Generics and Biosimilars Initiative (GaBI) is currently finalizing a whitepaper based on the July 26th webinar hosted by ASBM and GaBI entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines. View the full webinar here or watch individual segments linked below. Medicare Part D Experts Discuss Likely IRA Effects 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 of Federal Government Affairs, Gilead Sciences Drug Developer Discusses Impacts on R&D – Steven Potts, PhD, MBA Innovation and Patient Access – Andrew Spiegel, Esq; Executive Director, Global Colon Cancer Association
The article will appear in the next issue of GaBI Journal.
|ASBM Letter to Congress Defends Interchangeability Standard In a letter to Senator Mike Lee (R-UT) dated September 27th, ASBM urged the Senator to reconsider his support for 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”. 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. 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.
In conclusion, weakening the interchangeability standard is an unnecessary and potentially harmful step. By limiting the type of data the FDA can consider when determining suitability for automatic substitution it risks undermining the data-driven confidence physicians and patients have developed in interchangeables. Read the full letter here.
|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 Present at World Drug Safety Congress Americas 2023|
On October 19th, ASBM Advisory Board Chair Philip Schneider will present 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”. 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. Learn more about the Congress here.
|ASBM’s Schneider to Discuss Interchangeable Biosimilars at Summit on Biologics On November 2nd, ASBM Advisory Board Chair Philip Schneider will participate in the opening panel discussion at the 8th Annual National Policy & Advocacy Summit on Biologics. The panel is entitled The Evolving Biologics Landscape and will examine the biosimilar marketplace- what has happened in the last year, the impact of adalimumab biosimilars, and what’s next. Other panelists include rheumatologist Angus Worthing, MD; and Amgen’s Leah Christl, PhD; former Director of the Therapeutic Biologics & Biosimilars Staff at the FDA. The event will convene patients, providers, policymakers and advocates to discuss a number of topics impacting the health care space and will be held at the Mayflower Hotel in Washington D.C. from 9:30 am – 2:00 pm ET. Register for the 2023 National Policy & Advocacy Summit on Biologics here.|
|FDA Approves First Tocilizumab Biosimilar On September 29th, the FDA approved Tofidence (tocilizumab-bavi) as biosimilar to Actemra (tocilizumab). The product is an interleukin-6 (IL-6) receptor antagonist that targets specific inflammatory proteins to suppress the immune system. It is administered via intravenous infusion. Tofidence is approved for the following indications: rheumatoid arthritis in adults, polyarticular juvenile idiopathic arthritis ages 2 and older, and systemic juvenile idiopathic arthritis ages 2 and older. This is the first biosimilar approved to treat systemic juvenile idiopathic arthritis, and the 43rd biosimilar approved by the FDA since 2015.|
Read more about the approval here.
|Peter J. Pitts: The IRA makes the risks of developing new drugs too high|
On September 14th, an op-ed by former FDA Associate Commissioner Peter J. Pitts ran in the Pittsburgh Post-Gazette, in which he highlighted his concerns with Medicare drug price-setting policies stemming from the Inflation Reduction Act (IRA), passed last year. While the law’s price controls on prescription drugs haven’t taken effect yet, but they’re already causing companies to pause research and development efforts, Pitts explains. This is particularly bad for patients with rare diseases: Shortly after the law was signed, biotech firm Alnylam halted development of a drug targeting Stargardt disease, a rare genetic condition that causes vision loss. The company cited the IRA’s poorly designed exemption scheme for “orphan” drugs that treat rare conditions. The medicine was already approved to treat a different rare disease that causes nerve damage, and if the FDA had approved the drug for the additional use, vutrisiran could have lost its orphan status and been subject to price controls. Consider how these perverse incentives could prevent the development of the next Keytruda, the Merck miracle drug perhaps best known for helping former President Jimmy Carter beat cancer. First approved in 2014 to treat one condition, melanoma, Merck now lists 19 separate conditions it can treat — a massive boon for desperate patients. Thanks to the IRA’s price controls, medical marvels like Keytruda will now be even more difficult to achieve. Financing additional research and development into existing treatments will be difficult to justify. Read the full op-ed here. View ASBM’s recent webinar on the IRA’s effects here.
|UPCOMING EVENTS WHO 77th INN ConsultationGeneva, Switzerland – October 17, 2023|
World Drug Safety Congress AmericasBoston, MA – October 18-19, 2023 BIO Patient & Health Advocacy Summit
Washington, DC – October 22-24, 2023 National Policy & Advocacy Summit on Biologics
Washington, DC – November 2, 2023 ACR Convergence 2023
San Diego, CA – November 10-15, 2023