Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative ...

The U.S. Food and Drug Administration (FDA) has accepted for review Biologics License Applications (BLA) for AVT05, ...

Alvotech and Teva announced FDA acceptance of the Biologics License Application (BLA) for AVT05, a proposed biosimilar ...

The FDA accepted applications for a golimumab biosimilar, while Samsung Biologics reported record sales, and a Japanese ...

AVT05 is a biosimilar candidate to Johnson & Johnson's (JNJ) Simponi and Simponi Aria, also known by their generic name, golimumab, which are approved to treat a variety of inflammatory conditions.

Biologics License Applications for AVT05, their proposed biosimilar to the anti-inflammatory drugs Simponi and Simponi Aria. Review of the applications is expected to by completed in Q4 2025, ...

The company noted that these are the first U.S. BLA filing acceptances announced for a biosimilar candidate to golimumab. The FDA review process is anticipated to be completed in the fourth ...

Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva ...

Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced that the FDA has ...