Two new voices have emerged with goals to help expand patient access and information about biosimilars in the United States—the Biosimilars Forum and the Biosimilars Council, discussed below. Along with these voices, the New York State Bar Association’s (NYSBA’s) Food, Drug and Cosmetic Law Section (FDC Law Section) Biologics Law Committee is working with NYSBA’s Health Law Section, Committee on Medical Research and Biotechnology, to take a look at and consider legislative changes for state laws regarding substitution, as well as reimbursement and biological analytics. NYSBA is the largest voluntary state bar organization in the nation and welcomes attorney members of any state bar to join and get involved in Sections and Committees. As the Chair of the FDC Law Section, McGuireWoods LLP’s Brian Malkin, would like to invite interested members to join us for a rooftop networking event (see Events tab below the picture) in New York City next week (Thursday, May 14, 2015), co-hosted by the Committee on Medical Research and Biotechnology, to learn more about our respective Sections, as well as the Committees. The FDC Law Section is leading the way with NYSBA’s new Communities as a way for members to communicate with one another and share information, as we consider ways to help to meaningfully contribute to the development of sound laws, policies, and regulations in the food and drug law arena, as previously discussed here.
On May 5, 2015 a coalition of 11 major companies involved in the development and manufacturing of biological products announced the formation of the Biosimilars Forum, a nonprofit organization dedicated to expanding patient access to biosimilars in the United States. The 11 founding members of the Biosimilars Forum are Actavis, Amgen, Boehringer Ingelheim, Coherus BioSciences, EMD Serono, Hospira, Merck, Pfizer, Samsung, Sandoz, and Teva. According to the press release, the Biosimilars Forum plans to provide evidence-based information to educate and advocate for public policies and practices that encourage access, awareness, and adoption of biosimilars. The recently-elected officers of the Biosimilars Forum are President, Juliana Reed, Vice President, Global Government Affairs, Hospira, Inc.; Vice President, Hillel Cohen, Ph.D., Executive Director, Scientific Affairs, Sandoz Biopharmaceuticals (a Novartis company); Treasurer, Geoffrey Eich, Executive Director, External Affairs, Amgen Biosimilars; and secretary, Stacie Phan, Director, State Government Affairs and Public Policy, Boehringer Ingelheim. The press release further stated that the Biosimilars Forum plans to submit a public statement about the need for appropriate coding for biosimilars to the Centers for Medicare and Medicaid Services (CMS) Healthcare Common Procedure Coding System (HCPCS) Public Meeting on May 7, 2015.
On April 16, 2015, the Generic Pharmaceutical Association (GPhA) announced the launch of the Biosimilars Council, a division of GPhA. “Following unanimous Board of Directors’ approval, the Biosimilars Council is the culmination of the Association’s longstanding and unwavering commitment to patient access to safe, affordable, and lifesaving biosimilar medicines. The GPhA Biosimilars Council is designed to meet the unique needs of healthcare companies as they navigate this emerging space,” said Craig Wheeler, GPhA Board Chairman, and President and CEO of Momenta Pharmaceuticals, Inc. According to the press release, the Biosimilars Council will comprise manufacturers and stakeholders working to ensure a positive regulatory, reimbursement, political, and policy environment that supports patient access to these more affordable new medicines. The Biosimilars Council plans to focus on education, access, the regulatory environment, reimbursement, and legal affairs. The press release further states that it has a “roster of committed members and full start-up funding . . . to substantially supplement GPhA’s already strong regulatory, government affairs, policy, communications/education team to support anticipated activities.” The Biosimilars Council posted its first publication, an educational handbook, The Next Frontier for Improved Access to Medicines: Biosimilars and Interchangeable Biologic Products.