Christl, L. The problem with potential changes to the biosimilar regulatory framework. 26. 09. 2023. GUIDANCE DOCUMENT: Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act. Draft ...
The guidance includes information on the type and quantity of evidence needed to demonstrate interchangeability of a proposed therapeutic protein product; how switching studies or other studies to support interchangeability should be designed; how reference ...
The FDA issued afinal guidanceon the pathway for interchangeable biosimilar drugs. The guidance is intended to assist sponsors in demonstrating the interchangeability of a proposed therapeutic protein with a reference product, the pathway for which is created by the Public Health Services Act (“PHS A...
The guidance provides an overview of scientific considerations and discusses the type and amount of data needed to support interchangeability. Specifically, the guidance addresses product-dependent factors such as product complexity and immunogenicity risk. Biosimilar postmarketing data are also discussed. F...
The FDA has released a draft guidance for industry entitled “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act.” According to the FDA, the draft guidance is “intended to inform prospective applicants and facilitate the development of proposed bio...
Guidance intends to help sponsors demonstrate Interchangeability with a reference product. The FDA has released its draft guidance regarding biosimilar interchangeability, recommending that sponsors conduct 1 or more switching studies to demonstrate safety and efficacy in patients alternating between the 2 ...
Determination of interchangeability and the naming of interchangeable products will be covered in a future guidance, and FDA requested feedback on how to name interchangeable products. Related biological products FDA categorized products not just as originator or biosimilar, but as or...
FDAreleasesthreebiosimilarsguidances The U.S. FDA finalized and published three new guidances which clarifies what’s needed to submit so-called 351(k) applications to the agency in order to gain new approvals. Although companies are eagerly awaiting the guidance on interchangeability and also clos...
[7] FDA. Draft Guidance for Industry Biosimilarity and Interchangeability: Additional Draft Q & As on Biosimilar Development and the BPCI Act (November 2020) [EB/OL]. (2020-11-19) [2023-03-06]. https://www. fda.gov/media/143847/download. [8] FDA. Draft Guidance for Industry Drug ...
• FDA is in the process of updating its guidance to the pharmaceutical industry on interchangeable biosimilars to recommend fewer tests to demonstrate interchangeability.• Biosimilars and interchangeable biosimilars have had a positive impact on public health.• Use FDA’s Purple Book Database...