The U.S. Food and Drug Administration (FDA) today announced action to make it faster and less costly to develop biosimilar medicines, which are lower-cost alternatives to expensive biologic drugs used ...

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 ...

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 ...

A top official from the US Food and Drug Administration (FDA) offered a mixed assessment of the agency’s biosimilars program, noting that although the program is growing, there is more uptake of the ...

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 ...

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 ...

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 ...