The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.
On May 21, 2019, FDA published guidance on the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act (PHS Act). The guidance also offers recommendations on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) portion of a marketing application for a proposed product submitted under section 351(k) of the PHS Act.
Among an overview of the PHS Act and the Biologics Price Competition and Innovation Act of 2009 (BPCI Act), the guidance specifically discusses expression systems, manufacturing processes, physicochemical properties, functional activities, target binding, impurities, reference products and standards, finished drug products, and stability. Considerations addressed for a comparative analytical assessment include reference and biosimilar products and data analysis.
The guidance is part of a series of documents to facilitate the implementation of the BPCI Act. Other guidance documents address scientific considerations, biosimilar development, clinical pharmacology data, labeling of biosimilars, and demonstrating interchangeability.
Source: FDA
MHRA Approves GSK Therapy Combinations for Multiple Myeloma
April 21st 2025Belantamab mafodotin is approved in combination with bortezomib plus dexamethasone in patients who have had at least one prior therapy, and in combination with pomalidomide plus dexamethasone for those who have had a prior therapy including lenalidomide.
Thermo Fisher Opens Advanced Therapies Collaboration Center in California
April 18th 2025The 6000-square-foot facility will provide cell therapy developers the support they need to transition to CGMP manufacturing, and an expanded footprint of the new center is expected to open in Philadelphia later in 2025.