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

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

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 ...

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

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 ...

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

In 2024, the use of generic and biosimilar medicines saved $467 billion for the United States health-care system and the patients who use it, according to a recent report by the Association for ...

Biocon recently unveiled three new biosimilar oncology assets to its R&D pipeline —trastuzumab/hyaluronidase (Herceptin ...

The Federal Circuit heard oral arguments this week in Amgen v Sandoz, and the dispute centres on a seemingly simple question that goes to a key part of the Biologics Price Competition and Innovation ...