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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Survey Presentation at Spanish Ministry of Health On November 25, Executive Director Michael Reilly presented the European Survey results at the “1st EuropaBio – ASEBIO Meeting on Innovation and Biological Therapies” at the Spanish Ministry of Health, Social Services and Equality in Madrid. The event was hosted by EuropaBio and the Spanish Bioindustry Association (ASEBIO) and was the first time specific Spanish responses and data were presented and compared to responses from physicians in the other countries surveyed. Mr. Reilly pointed out that while Spanish physicians have a better understanding of biologics and biosimilars than their European counterparts, only 28% of Spanish physicians are “very familiar” with biosimilars and almost a quarter of Spanish physicians surveyed – 23% – could not define or had not heard about biosimilars before. Additionally, physicians in Spain overwhelmingly indicated that they should have the sole authority to decide the most suitable biologic medicine for their patients with 88% agreeing that they alone should be the decision-maker. The meeting included regulators from the Spanish Ministry of Health, physicians from Spanish oncology and rheumatology societies, representatives from a hospital pharmacist organization and patient groups. Read the press release here. |
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DIA Biosimilars Conference in Berlin On December 2, ASBM Executive Director Michael Reilly presented results from the European Survey at the DIA Biosimilars Conference held in Berlin, Germany. The conference focused on current regulatory, scientific and market access perspectives for biosimilars. ASBM provided a physician’s perspective on biosimilars on the “Health Care Professionals’ and Patients’ Perception, Understanding and Experience of the Biosimilar Concept” panel. Read more here. |
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Dr. Gewanter Responds to Hill Op-Ed On November 18, Dr. Gewanter responded to an Op-Ed in The Hill by Tom Schatz, president of Citizens Against Government Waste, by pointing out that biosimilars were wrongly categorized in his piece as a trade/competition issue when it is really a patient safety issue. Dr. Gewanter wrote the following statement: “But Mr. Schatz makes a common error in equating biologic medicines with chemical medicines. Unlike generic copies of chemical medicines, the complexity of biologics means that an attempted copy will never be identical. A biologic produced from a different cell line can, at most, be ‘similar,’ hence the term ‘biosimilars.’ This scientific reality is why biologics cannot simply be treated as generics by regulators. Even minor differences can create adverse impact in patients, including unwanted immune responses. How similar is ‘similar enough’ to safeguard patient safety? The Food and Drug Administration (FDA) has wisely taken its time in drafting approval criteria and other guidance to answer that question accurately.” Read more here. |
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Rep. Bobby Rush Op-Ed in Huffington Post On November 6, Rep. Bobby Rush (D-Ill.) penned an Op-Ed for the Huffington Post on his concerns for ensuring safety as biosimilars are approved in the U.S. In Biosimilars – Another Untold Story of the Affordable Care Act he says: There is “an earnest debate, currently taking place both in Washington, DC and in state capitals across the country, about how laws governing pharmacy practices can be updated to expand access to these drugs. While the nuances of the legislation and rules considered in each state may vary, one underlying issue has been raised in every state discussion thus far: the need to ensure active pharmacist-prescriber communications when it comes to dispensed biologics and biosimilars. “Prescribing physicians need to know which biologic has been dispensed to support patient care in the event that a patient has an adverse response and has received multiple biologics. This is relevant not only to retail dispensed biological products, where a pharmacist and physician may not normally communicate about the history of a patient’s medicines, but also to mail-order prescriptions where the occurrence of pharmacist and prescriber communication is even less likely to take place.” Read more here. |
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GaBI Newsletter Features ASBM WHO Presentation On November 11, ASBM was highlighted in the Generics and Biosimilars Initiative (GaBI) newsletter for presenting on naming at the WHO 59th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. From More Discussion on WHO Biological Qualifier: “During the meeting, which took place from 14–16 October 2014, the Alliance for Safe Biologic Medicines (ASBM) gave a presentation on ‘Global biosimilar naming standards: physician (and patient) perspectives’ in support of the WHO’s draft biological qualifier (BQ) proposal. “The WHO BQ proposal would assign a four-letter alphabetic code to all biologicals [1]. The ASBM, which represents healthcare, patient and physician groups, as well as originator biologicals companies, believes that the WHO’s BQ will prioritize patient safety. In September 2014, the ASBM and 14 of its member groups submitted comments to WHO supporting the BQ proposal because it ensures clear product identification and promotes manufacturer accountability.” Read the article here. |
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Medscape Interview with Dr. Margaret Hamburg Eric Topol, Editor-in-Chief of Medscape, sat down with Dr. Margaret Hamburg, commissioner of the U.S. Food and Drug Administration (FDA), as part of the Medscape series on the most interesting people in medicine. In the interview “FDA’s Hamburg on Balancing the Risks, Benefits for 310M Patients” Dr. Hamburg addresses biosimilars. Watch the interview here. |
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EMA Revises Biosimilars Guideline In October, the European Medicines Agency (EMA) published a revised version of its 2005 overarching biosimilars guidelines that contains new recommendations on how to bring biosimilars to market in Europe. Read more here. |
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Upcoming Conferences:
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