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.
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FDA Hosts Public Hearing on Biosimilars On January 7, ASBM members Global Colon Cancer Association (GCCA), Global Healthy Living Foundation (GHLF) and the Alliance for Patient Access (AfPA) all testified at the FDA’s Oncologic Drugs Advisory Committee (ODAC) public hearing on biosimilars. The patient groups expressed support for the pending approval, but also outlined what was needed to continue to grow patients’ confidence in the biosimilars program. In his testimony, Andrew Spiegel, GCCA executive director and ASBM Steering Committee member, said: “Fundamentally, patients want to know that we can expect the same safety, purity, quality and efficacy from an FDA-approved biosimilar that we can from its FDA-approved reference biologic. That level of confidence can only come through data which demonstrates therapeutic equivalence over time. That means observing the effects of these medicines in larger populations, through clinical trials and post-market surveillance.” Read his full testimony here. ASBM Quoted in FDA Week on Biosimilars Meeting ASBM Executive Director Michael Reilly was interviewed by FDA Week prior to the ODAC meeting on how the meeting was an important opportunity for the FDA to hear from stakeholders. From Biosimilar Advisory Meeting May Offer Final Platform For Naming Debate: “The advisory hearing could serve as an important platform for FDA to hear stakeholders’ input on issues such as biosimilar naming as the agency nears its possible first biosimilar approval, said Michael Reilly, executive director of the Alliance for Safe Biologic Medicines. The first approval will reveal the agency’s thinking on biosimilar naming as well as other issues surrounding the data and tests required as part of the review process, he added.” Read more here. |
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FDA Releases List of Upcoming Biosimilar Guidances for 2015 On January 6, the FDA released its annual Guidance Agenda detailing which new and revised Draft Guidances will be issued by its Center for Drug Evaluation and Research (CDER) for 2015. Among them are four guidances pertaining to biosimilarity. Topics covered include: what data will be allowed for demonstrating biosimilarity, labeling requirements for biosimilars and how interchangeability will be determined. Read more here. |
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Physician Groups Advocate for Unique Names The Alliance for Patient Access and other specialty physician groups wrote a letter to the FDA on the importance of giving biosimilars unique names. On December 26, FDA Week highlighted their position in Some Doctors Push Distinct Biosimilar Names, Breaking from AMA Stance: “A handful of specialty physician groups are siding with the innovator biologics industry in urging FDA to adopt a biosimilar naming scheme under which products have distinguishable names, pushing back against arguments made by an American Medical Association council and generic drug makers for shared International Nonproprietary Names (INNs). The groups, like innovator companies, argue that distinct names are needed to track adverse events and to protect against improper pharmacy substitution. “The specialty physician groups wrote to FDA Thursday (Dec. 18) that a shared name would imply interchangeability, referencing statements made by the agency in past about how INNs should not be used to ‘imply pharmacologic interchangeability of products with the same active ingredient(s).’“ Read more here. |
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New ASBM Canadian Survey Released at Ottawa Workshop On December 10, ASBM Executive Director Michael Reilly presented the results from a new Canadian Survey of physicians’ views at the Subsequent Entry Biologics in Canada: Current State of the Science workshop in Ottawa. The goal of the Canadian Physician Perspectives on Subsequent Entry Biologics (SEBs) survey is to provide empirical data to Health Canada and other regulators on the perspective of Canadian physicians regarding SEBs (biosimilars), particularly for naming. The survey included 427 prescribers made up of dermatologists, gastroenterologists, internists, oncologists, pulmonologists, neurologists, urologists, nephrologists, rheumatologists and endocrinologists. The physicians were from four provinces in Canada – Alberta, British Columbia, Ontario and Quebec. Read more here. |
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ASBM to Offer Class on Biosimilars to Pharmacists ASBM is organizing a CE class for pharmacists on the fundamentals of biologics that will be offered through the Long Island School of Pharmacy. The five-hour class “The Fundamentals of Biosimilars: What Every Pharmacist Will Need to Know” will help pharmacists: 1. Discuss the basic science and manufacturing of biologic medicines. The class will be held on March 15 at the New York LaGuardia Airport Marriott. |
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Upcoming Conferences:
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