The Need for Biosimilars in Inflammatory Diseases and Regulatory Requirements for Approval
Drs Lio, Botsoglou, and Alexrad discuss the need for biosimilars in inflammatory diseases, and clinical pharmacist Dr Humphreys reviews the regulatory requirements for biosimilars to receive FDA approval.
Biosimilars vs Bad Patents: Accessibility, Key Court Cases With Ha Kung Wong
March 10th 2024Intellectual property attorney, Ha Kung Wong, JD, discusses concerns about "bad patents" hindering biosimilar access, but assures that the FDA and United States Patent and Trademark Office are working to improve the system.
Patent Shift Predictions, Legal Landscapes of Biosimilars With Ha Kung Wong
February 25th 2024Ha Kung Wong, JD, examines proposed patent law changes that could significantly impact the biosimilars sector, including limitations on asserted patents, elimination of interchangeability requirements, and heightened oversight of pharmacy benefit managers.
Dr Chelsee Jensen Discusses Pricing Strategies for Adalimumab Biosimilars
November 26th 2023Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, explains the purpose of dual-pricing strategies for adalimumab biosimilars and predicts whether these strategies will occur in other treatment spaces.