DIA, in cooperation with the Food and Drug Law Institute (FDLI), will host Future of Biosimilars in the US: Legal, Regulatory, Scientific, Regulatory, Clinical and Payer Issues from May 4-5 in North Bethesda, MD.
FDA, industry, lawyers, academics, clinicians, payers, and patients will discuss the challenges and opportunities associated with the introduction of biosimilars to the US, including:
- Level of similarity and extent of physiochemical and biological data required to demonstrate the follow-on protein to be “highly similar” to the innovator product and to qualify as a biosimilar
- Value of nonclinical testing for the demonstration of “biosimilarity”
- Criteria to achieve interchangeability status
- Exclusivity under the BPCIA
- Supplemental qualifications for exclusivity
- Intellectual property protection and litigation
- Labeling and nomenclature need to be applied to biosimilars
- Patient access to expensive biological medicines and extent that patient choice becomes compromised or even severely limited
“The Biologics Price Competition and Innovation Act (BPCIA) was enacted into law as part of US healthcare reform, establishing an approval pathway for biosimilar biological products in the US,” explains Program Co-chair Philip L. Huang, MBA, MD, Vice President, Vaccine Strategy & Innovation, Merck & Co., Inc. “This Act and the way it is implemented will have a huge impact on the development and availability of biological medicines in the US, both from an intellectual property and market access perspective.”
ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.