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

Samsung Bioepis released its Q1 2026 Biosimilar Market Report, which provides an overview of the market status of all ...

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 ...

Each year, the FDA approves a wide range of medications that help shape the future of medicine in the U.S. These include novel drugs that offer new treatment options, as well as first generics and ...

The letter was sent to Sens Cassidy, M.D. (R-La.) and Sanders (I-Vt.), chair and ranking member of the Senate Health ...

As cancer cases climb steadily across India, lower-cost biosimilars like Tishtha could reshape access to life-saving ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

Ondibta is approved for the treatment of diabetes mellitus in adults, adolescents and in children aged two years old and ...

The FDA has decided that biosimilar medications must have unique naming features, distinguishing them from brand-name biologics in a move to improve patient safety, according to a STAT news report. 1.

Blau Farmacêutica, a Brazilian pharmaceutical company listed on Brazilian Stock Market (B3) and a regional leader in hospital pharmaceuticals with a strong presence across Latin America, announces an ...

With the first biosimilar approved by the US Food and Drug Administration (FDA) in March and a second approval likely in the next few months, practical and operational challenges are already starting, ...

The launch follows a Delhi High Court nod allowing sales of the cancer drug biosimilar ahead of patent expiry in May 2026.