In a new draft guidance, issued on October 29, 2025, the FDA proposed major updates to simplify biosimilarity studies and potentially reduce clinical testing for therapeutic protein products. The ...

Aydin Harston Ph.D., Alexander Shaver Ph.D. FDA approves Omylco® (omalizumab), first biosimilar of Xolair®. After Q1, FDA and EMA on track for a record number of biosimilar authorizations in 2025.

FDA-approved carbon copies of brand-name drugs with expired patents—over the last 30 years, these generic drugs have saved ...

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 (FDA) is launching an effort to streamline the approval process for cheaper alternative “biosimilar” versions of biologic drugs as a way to curb health costs. The ...

The U.S. Food and Drug Administration has approved Sanofi-Aventis's Merilog (insulin-aspart-szjj) as a biosimilar to Novolog (insulin aspart) for adults and pediatric patients with diabetes mellitus.

Nine out of 10 prescriptions are filled by generic drugs - FDA-approved carbon copies of brand-name drugs with expired patents. Over the last 30 years, generic drugs have saved trillions of dollars ...

Teva Pharmaceuticals Stock: Unlock Value in This Generic Drug Gem Alvotech (NASDAQ:ALVO) Chief Strategy Officer Balaji Prasad ...

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, ...

The US Food and Drug Administration (FDA) on Tuesday approved the second biosimilar in the US, known as Inflectra (infliximab-dyyb), which is biosimilar to Janssen Biotech’s Remicade (infliximab).