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.”
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the discovery, development, and life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.