In the News: Advances in Manufacturing Key to Biosimilar Approval Fast Track

Late last week the FDA issued its long-anticipated draft guidance documents governing the development of biosimilars. As reported in FiercePharma Manufacturing the documents contain numerous references to how technological and manufacturing advances will help pave the way to abbreviated approvals. 

The FDA said “[g]reater knowledge due to advances in science and technology, and improvements in manufacturing processes, process controls, materials and product testing, as well as characterization tests and studies, facilitate the use of an abbreviated pathway for the approval of a protein product.”

The article goes on to detail more about the manufacturing process found in the FDA’s “Quality Considerations” document:  “A comprehensive understanding of all steps in the manufacturing process for the proposed biosimilar product should be established during product development. Characterization tests, process controls, and specifications that will emerge from information gained during process development must be specific for the proposed biosimilar product and manufacturing process. The use of Quality-by-Design approaches to pharmaceutical development, along with quality risk management and effective quality systems, will facilitate the consistent manufacturing of a high-quality product.”

 -- Joe Rothman