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GPhA establishes new division in Biosimilars Council


WASHINGTON — The Generic Pharmaceutical Association announced Thursday 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," stated Craig Wheeler, GPhA board chairman and president and CEO of Momenta Pharmaceuticals. "The GPhA Biosimilars Council is designed to meet the unique needs of healthcare companies as they navigate this emerging space,” he said.


“In addition to being a voice with policymakers, this new division will be an invaluable partner for patients, providers, manufacturers, consumer groups and stakeholders from all corners of the supply chain seeking to stay apprised of critical developments regarding biosimilars,” Wheeler said. “The GPhA Biosimilars Council also will be a key resource for organizations seeking relationship building opportunities, and a forum for indepth scientific, regulatory, legislative and policy discussions.”


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 also is the industry’s first educational resource for the general public and patient groups seeking information about the safety and effectiveness of biosimilars.


Among the first offerings of the Biosimilars Council is a new educational handbook, "The Next Frontier for Improved Access to Medicines: Biosimilars and Interchangeable Biologic Products." This publication explains the benefits and science behind biosimilar medicines — safe, effective alternatives to costly biologic therapies. It explains who will benefit from access to these medicines, outlines the legal and regulatory framework, and illuminates the quality manufacturing and development process in approachable language. 


The GPhA Biosimilars Council will begin operations immediately. As per recently adopted changes to the GPhA bylaws, a Biosimilar board, elected by members of the Biosimilars Council, will develop the Association’s biosimilar activities and programming consistent with the longstanding mission of GPhA and the association’s board of directors. With a roster of committed members and full startup funding, the new division will supplement GPhA’s regulatory, government affairs, policy and communications/education team to support anticipated activities. The GPhA Biosimilars Council will welcome all biosimilar companies dedicated to bringing more affordable biosimilar medicines to US patients as it works to continue its leadership in supporting this emerging industry.


“GPhA and its members historically have been the industry pioneers on biosimilars, beginning with their role as the fundamental organizing force behind the law which created the biosimilar pathway. The Biosimilars Council is the next evolution in this leadership, and will ensure these new medicines will deliver tremendous benefits for both our health and our healthcare system,” said GPhA president and CEO Ralph Neas. “We look forward to continuing to work with our strategic partners and all stakeholders who share our vision of the transformative potential of biosimilars and interchangeable biologics.”


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