Mayo Clinic’s Chelsee Jensen, PharmD, discusses FDA policy changes, biosimilar development hurdles, denosumab lessons, and ...

The Centers for Medicare & Medicaid Services just announced the next 15 brand-name medicines selected for Medicare’s drug ...

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 ...

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

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 ...

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.

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

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

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, ...