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

The US Food and Drug Administration (FDA) has debuted new draft guidance that aims to streamline and expedite the biosimilar development process.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

Add Yahoo as a preferred source to see more of our stories on Google. FDA Commissioner Marty Makary speaks in the Oval Office at the White House on May 05, 2025. (Anna Moneymaker via Getty Images) ...

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 ...

Alvotech inks supply and commercialization pacts with Sandoz covering multiple biosimilar candidates in Canada, Australia & New Zealand: Reykjavik, Iceland Tuesday, February 3, 20 ...

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

Alvotech, a biotech firm focused on biosimilar medicine development, announced the acquisition of Xbrane Biopharma’s R&D operations and a biosimilar candidate named XB003, aimed at extending its ...

If the Trump White House is serious about its push to make medicines more affordable, it should ensure CMS officials never ...

(Reuters) -India's Biocon expects a 50% drop in costs for developing complex biosimilars as the United States has proposed to ease clinical testing for the drugs that make up more than 60% of its ...

Biosimilars are driving down drug costs, expanding access to critical treatments, and creating space for future innovation. In this episode, Linda Choi MacDonald, EVP and Global Head of Commercial at ...

With a strong presence in Canada, Australia and New Zealand, Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and ...

Biosimilars have yet to achieve their main purpose: to reduce the costs of complex biological drugs, as generics do for small molecules. Multiple barriers, from development costs to the contracting ...