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

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

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 Food and Drug Administration said it will take steps to speed up the process of developing generic versions of complex biological drugs, in a bid to increase cheaper competition for expensive ...

How long before the biosimilar market looks like the generics market? While still a relatively new area of biopharma, the biosimilar market has been getting more and more competitive, with huge ...

The Biosimilars Council applauded the bipartisan introduction of the Biosimilar Red Tape Elimination Act in the U. S. House of Representatives. The legislation, sponsored by Representatives Pfluger (R ...

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