The FDA expanded the approval of mirikizumab (Omvoh) to include treatment of adults with moderately to severely active ...

The FDA has approved Omvoh for the treatment of moderately to severely active Crohn’s disease, making it the second ...

A study from Spain found a subcutaneous tocilizumab biosimilar to be cost-effective when treating patients with rheumatoid ...

The US Food and Drug Administration (FDA) has approved Omvoh (mirikizumab-mrkz), from US pharma major Eli Lilly, for the ...

Formycon and Fresenius Kabi secure UK approval for Otulfi, a ustekinumab biosimilar targeting inflammatory conditions.

J&J will protect the branded anti-interleukin (IL)-12/23 biologic Stelara against sales erosion from biosimilars.

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 ...

Regulatory ApprovalFormycon and Fresenius Kabi announce MHRA approval for FYB202/Otulfi® (ustekinumab), a biosimilar to Stelara® 15.01.2025 / 06:30 CET/CESTThe issuer is solely responsible for the ...

As 2025 begins, we would like to reflect on last year’s regulatory developments in the biologics and biosimilars space. Here are ...

Biocon shares increased by 4.5% after the US FDA classified its Malaysian insulin facilities as Voluntary Action Indicated.

Adalimumab and secukinumab are the only FDA-approved biologic drugs to treat hidradenitis suppurativa, limiting options for ...