Biosimilars have yet to achieve their main purpose: to reduce the costs of complex biological drugs, as generics do for small molecules. Multiple barriers, from development costs to the contracting ...
On September 11, 2025, the U.S. Food and Drug Administration (FDA) issued new guidance for the development of therapeutic protein biosimilars, focusing on comparative analytical assessment and quality ...
Janet Woodcock, the acting commissioner of the US Food and Drug Administration (FDA), says there has been a “significant increase” in biosimilars approvals as the pharmaceutical industry has shown ...
A new independent analysis of the US Food and Drug Administration's (FDA) workload around biosimilars over the first three years shows how biosimilar development has slowly progressed as companies ...
The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...
The updated guidance allows originators to cite existing comparative data, not exclusively from the United States, for clinical pharmacokinetic testing. This updated guidance in conjunction with ...
Last year marked an all-time record of 18 Food and Drug Administration (FDA) biosimilar approvals, bringing the total number of FDA-approved biosimilars to 63. Forty-one of those biosimilars have ...
Alvotech, a biotech firm focused on biosimilar medicine development, announced the acquisition of Xbrane Biopharma’s R&D operations and a biosimilar candidate named XB003, aimed at extending its ...
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