In 2024, the FDA approved 19 biosimilars across various therapeutic areas, including the first biosimilars for ustekinumab ...

As Sandoz gears up to launch one of the most anticipated biosimilars of the year, the company could face near-term ...

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

Discover how the three largest pharmacy benefit managers are rejecting biosimilars from their formularies, except for their own private-label drugs.

This year the biosimilars to Stelara (ustekinumab) stand to be the stars of the biosimilars show. The FDA has approved seven ...

An ustekinumab biosimilar to Stelara launched in France, completing its rollout across 5 major European markets and paving ...

With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be ...

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

Formycon and Fresenius Kabi announce MHRA approval for FYB202/Otulfi® (ustekinumab), a biosimilar to Stelara® Otulfi ® received MHRA approval for both subcutaneous and intravenous formulations, to ...

Earlier patent litigation can be reformed to reflect similar success across Europe, resulting in accelerated US biosimilar ...

Regulatory ApprovalFormycon receives EU approval for FYB203 (aflibercept), a biosimilar to Eylea®, under the brand names AHZANTIVE® and Baiama® 20.01.2025 / 06:30 CET/CESTThe issuer is solely ...