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

The Association for Accessible Medicines and its Biosimilars Council have released an analysis undertaken by the IQVIA Institute for Human Data Science on behalf of AAM assessing the impact of patent ...

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

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 ...

According to multiple recent market analyses, the global API market is experiencing steady growth. One comprehensive forecast ...

Both Alvotech ALVO and Teva Pharmaceuticals TEVA operate in the biosimilar space, but their business models differ significantly. ALVO has built its revenue model around partnerships, relying on ...

The FDA has decided that biosimilar medications must have unique naming features, distinguishing them from brand-name biologics in a move to improve patient safety, according to a STAT news report. 1.

With the first biosimilar approved by the US Food and Drug Administration (FDA) in March and a second approval likely in the next few months, practical and operational challenges are already starting, ...

FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo (Reuters) -The U.S. Food and ...

Enzeevum, a biosimilar to Eylea, is approved in Canada for multiple retinal conditions, expanding treatment options for ...