An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

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 ...

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

The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process. The regulatory framework has been designed to reduce ...

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

2024 saw the highest number of biosimilars approved by the US Food and Drug Administration (FDA) in a calendar year, with this year set to break this record again, analysis suggests. The FDA approved ...

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

Please provide your email address to receive an email when new articles are posted on . Poherdy (pertuzumab-dpzb, Shanghai Henlius Biologics Co.), a HER2 receptor antagonist and biosimilar to ...

On Wednesday, Oct. 29, the Food and Drug Administration (FDA) issued draft guidance proposing to update its biosimilar review framework. Under the new approach, most biosimilar applications will no ...

While the FDA is streamlining regulation of copycat versions of the expensive drugs that millions take for arthritis, cancer, and other diseases, the U.S. patent office is making it harder for the ...

The FDA has approved Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Perjeta (pertuzumab). Poherdy, as approved, is indicated for use in adults with HER2-positive breast cancer, ...

AEON confirmed that earlier today it held its BPD Type 2a Meeting with the FDA, in line with prior guidance, and is now awaiting official ...