Formycon AG

The FDA has approved 64 biosimilars, including Steqeyma. Biosimilars are highly similar to FDA-approved reference products with no clinically meaningful differences. Interchangeable biosimilars meet additional requirements, allowing pharmacy-level substitution without prescriber intervention. Examples include biosimilars for Actemra, Avastin, Enbrel, and others, highlighting their safety, effectiveness, and cost-saving potential.

Formycon published results of analytical similarity study of biosimilar candidate FYB206 and Keytruda® in peer-reviewed journal Drugs in R&D, indicating FYB206 is structurally and functionally highly similar to Keytruda®, supporting ongoing clinical trials.

FDA approves Imuldosa, the fifth Stelara biosimilar for Crohn’s disease, ulcerative colitis, and other inflammatory conditions, expected to launch in early 2025.

Fresenius Kabi and Formycon AG received FDA approval for Otulfi (ustekinumab-aauz), a biosimilar of Stelara, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Fresenius Kabi's fourth biosimilar in the U.S. market, aligning with their Vision 2026 strategy to expand their biopharma portfolio globally.

Fresenius Kabi and Formycon AG announced FDA approval of Otulfi™ (ustekinumab-aauz), a ustekinumab biosimilar referencing Stelara®, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. This marks Fresenius Kabi's fourth biosimilar in the U.S., aligning with their Vision 2026 growth strategy to expand their biopharma portfolio globally.

FDA approves Otulfi, a fourth Stelara biosimilar, for chronic inflammatory diseases including Crohn’s and ulcerative colitis, expected to be available in the U.S. by February.

FDA approves Formycon AG's biosimilar FYB202/OtulfiTM (ustekinumab-aauz) for treating Crohn’s disease, ulcerative colitis, moderate-to-severe plaque psoriasis, and active psoriatic arthritis.

The CHMP recommended 14 medicines for EMA approval, including 6 biosimilars: EKSUNBI, FYMSKINA, OTULFI for psoriasis and related conditions; ITUXREDI for lymphoma and autoimmune diseases; RANIBIZUMAB MIDAS for eye diseases; and TUZNUE for breast and gastric cancer, all deemed similar to existing treatments.

FDA approves FYB203/Ahzantive® (aflibercept-mrbb), a biosimilar to Eylea®, for treating nAMD, DME, DR, and RVO, inhibiting VEGF. FYB203/Ahzantive® demonstrated comparable efficacy and safety to Eylea®, with global sales of around US$ 9 billion in 2023. A marketing authorization application for FYB203 was submitted to the EMA, with a decision expected by early 2025.