September is nearly upon us, and registration is open for the Association for Accessible Medicines (AAM) and its Biosimilars Council’s 2017 two-day conference – Leading on Biosimilars, taking place on September 12 & 13 in Washington, D.C. The conference will feature presentations from key industry leaders, U.S. Government agency officials, and academic experts regarding the dynamic landscape of the biosimilars industry. A primary focus of the conference will be sessions dedicated to educating the public, patients, and healthcare professionals about the safety and effectiveness of biosimilars.
The conference comes at a critical juncture, as the biosimilars market and the science behind these therapies align for accelerated growth. Below are five reasons why AAM and its Biosimilars Council believe now is the time to be “Leading on Biosimilars”:
- FDA-approved Biosimilars have been proven safe and effective. FDA-approved biosimilars have the same mechanism of action as the approved brand biologic counterpart--meaning the biosimilar works the same way as the reference product. The FDA requires biosimilar manufacturers to adhere to the same safety monitoring requirements of brand biologic manufacturers. (See the FDA’s position on biosimilars.) More than 10 years of biosimilars patient-use in the EU have shown no significant difference in health outcomes between patients who use a biosimilar and those who take the original branded biologic medicine.
- The economics of biosimilars are undeniable. According to the latest estimates, consumers could save as much as $250 billion in the first 10 years of biosimilar availability.
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- The FDA has grown more supportive of biosimilars. Recent unanimous recommendations by the Oncologic Drugs Advisory Committee (ODAC) may indicate a sustained embrace in an effort to catch the U.S. biosimilars market up to the European Union’s more robust environment.
- Big Pharma is realizing that “biosimilars are here to stay.” That’s the conclusion of an article that ran recently in the Specialty Pharmacy Times. The brand-name manufacturers are gradually acknowledging that current strategies used to rebuff biosimilar competition will have to be being revisited and tempered.
- The Supreme Court has weighed in. In June, the highest court in the land ruled, in a 9-0 decision, that biosimilar manufacturers will be able to bring their drugs to the market without an additional six-month delay that one brand-name biologics maker, Amgen, had sought. According to the SCOTUS blog, “The litigation arose after the generic pharmaceutical company Sandoz sought a license from the Food and Drug Administration to market an approximate copy…of Amgen’s ‘biologic’ drug filgrastim (trade name Neupogen). Sandoz’s application for an FDA license triggered a complex statutory mechanism for patent litigation under the Biologics Price Competition and Innovation Act.”
Christine Simmon is AAM Senior Vice President, Policy & Strategic Alliances and Executive Director of AAM’s Biosimilars Council.