CVS Health Inc. CVS on Thursday said it is taking additional steps to lower prescription drug costs by expanding access to ...

The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process.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

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 ...

As Sandoz looks to address the “biosimilar void” created by the scores of lucrative drugs going off patent in the next decade, the generic and biosim specialist sees a multibillion-dollar opportuni | ...

CVS Caremark will begin offering osteoporosis biosimilars Ospomyv and Stoboclo, as well as generic teriparatide, Bonsity and ...

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 ...

(Corrects paragraph 5 in February 5 story to say 2025 Prolia sales were $4.4 billion, not $1.05 billion) Feb 5 (Reuters) - ...

The FDA recently gave his company a waiver from conducting a costly clinical trial of its biosimilar substitute for Keytruda, a blockbuster cancer drug. But Merck & Co., which got about half of its ...

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, ...

On January 12, 2026, Sanofi announced that the European Commission approved its Teizeild (teplizumab) for delaying progression to stage 3 type ...

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 ...