The FDA defines a biosimilars as biologic products approved because they're highly similar to existing medicines, but there's a lot more to understand. A biosimilar is a manufactured biologic ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

Celltrion Inc., a major South Korean biopharmaceutical company, said Friday it has launched its biosimilar Avtozma for the ...

As Sandoz looks to address the “biosimilar void” created by the scores of lucrative drugs going off patent in the next decade ...

A new AAN position statement outlines guidelines for switching from branded biologics to biosimilars, while preserving clinical autonomy for physicians.

For companies developing interchangeable biosimilars, the FDA guidance opens the door to more tailored, risk-based programs that may reduce reliance on costly comparative efficacy studies (CES). For ...

The biologics market in the United States has grown an average of 12.5% annually over the past 5 years, according to data from the IQVIA Institute. 1 By 2026, these medications are expected to account ...

Welcome to Alston & Bird’s introduction to biological products regulation. In this five-part intro-level series, we provide answers to a number ...

A small study found MS patients reported improved quality of life and reduced depression after Ocrelizumab biosimilar ...

The FDA recently designated Yuflyma as "interchangeable" with the popular biologic Humira for the treatment of Crohn's disease and ulcerative colitis, two types of inflammatory bowel disease (IBD), ...