It’s been more than ten years since the FDA signed off on the United States’ first biosimilar product, opening up what was ...

TRENTON, N.J. (AP) -- Years after discounted versions of some of the most expensive drugs ever went on sale in other countries, they're finally coming to the world's biggest medicine market. Last week ...

US Oncologists anticipate rapid biosimilar uptake – up to 50% of PD-1/PD-L1 eligible patients within the first year – while ...

As drug pricing pressure intensifies and benefit structures shift, some health systems are still treating biosimilars as a selective cost lever — deploying them in certain payer segments while ...

Findings showed equivalent efficacy in change from baseline in weekly itch severity score between omalizumab-igec 300mg and Xolair 300mg. The Food and Drug Administration (FDA) has approved Omlyclo ® ...

The FDA approved omalizumab-igec (Omlyclo) as the first biosimilar for omalizumab (Xolair) and the first for any respiratory condition in the U.S., drugmaker Celltrion announced Monday. The ...

Michael Ellenberger, Aydin Harston Ph.D. On October 29, 2025, the U.S. Food and Drug Administration (FDA), in coordination with the Department of Health and Human Services (HHS) and the Centers for ...

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...

The FDA approved pertuzumab-dpzb (Poherdy) as the first biosimilar for its reference product Perjeta, a monoclonal antibody commonly used in standard regimens for HER2-positive breast cancer. FDA ...

Launch of European-made Uzpruvo in Europe comes immediately upon expiry of exclusivity rights for the molecule used to treat certain conditions in gastroenterology 1, dermatology and rheumatology ...