Topics include two Food and Drug Administration (FDA) pathways for biosimilars in BPCIA including the 351(k) (2) (A) on non-interchangeable biologic and 351(k) (2) (B) for interchangeable biologic. Also cited are questions on immunogenicity risks with biologic reference and interchangeability ...
Biosimilar and interchangeable biologics: more treatment choices. US Food and Drug Administration. Updated October 12, 2021. Accessed March 16, 2023. https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices ...
Biosimilars: Review and Approval. Accessed online April 5, 2023. https://www.fda.gov/drugs/biosimilars/review-and-approval 7. U.S. Food & Drug Administration. Biosimilar and Interchangeable Biologics: More Treatment Choices. October 12, 2021. Accessed online April 5, 2023. https://www.fda....
Biosimilars in Oncology: Latest Trends and Regulatory Status 2022, Pharmaceutics Improving access to cancer treatments: The role of biosimilars 2017, Journal of Global Oncology Biosimilars and Interchangeable Biologics: Tactical Elements 2016, Biosimilars and Interchangeable Biologics: Tactical Elements The adv...
FDA’s First Interchangeable Exclusivity Determination Results in ExpirationJanuary 11th, 2024 Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). As has been ...
FDA will also continue to educate clinicians, patients, and payors about biosimilar and interchangeable products as we seek to increase awareness about these important new treatments.”18 The dynamics of the US market are changing as the regulatory environment evolves. The US is undoubtedly...
Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products. This guidance provides specific recommendations for all three classes of products—biologics approved under 351(a) of the Pu...
Hear from Fran Gregory, VP of Emerging Therapies, and how Cardinal Health is expanding access to biosimilars. FDA resources for biosimilars If you are new to biosimilars, these resources may be useful: FDA Overview on biosimilars and interchangeable products ...
The BPCI Act is part of the healthcare reform legislation, which was signed into law on 23 March 2010 by President Barack Obama. The BPCI Act establishes an abbreviated approval pathway forbiological productsthat are demonstrated to be ‘highly similar’ (biosimilar) to, or ‘interchangeable’ ...
What is an Interchangeable? An interchangeable product is a biological product that meets all the requirements for a biosimilar product, but also meets additional requirements outlined by the Biologics Price Competition and Innovation Act. A manufacturer developing an interchangeable product will need to ...