Formycon and Fresenius Kabi Settled with Johnson & Johnson for FYB202, a Proposed Biosimilar to Stelara (ustekinumab)
Shots:
- Formycon and Fresenius Kabi entered into a settlement agreement with Johnson & Johnson concerning FYB202, a proposed ustekinumab biosimilar in the US. FYB202 can be marketed in the US subject to regulatory approval, no later than April 2025
- FYB202, a human mAb that targets the cytokines interleukin-12 and interleukin 23 for immune-mediated disorders. Stelara was approved for mod. to sev. PsO, CD, UCas well as active PsA
- Formycon seeks to submit the BLA in 2023. Formycon & Fresenius Kabi collaborated in Feb 2023 to commercialize the proposed ustekinumab biosimilar (FYB202) in key global markets after successful approvals while both companies share equal post-commercialization value
Ref: FORMYCON | Image: FORMYCON
Related News:- Formycon AG and its License Partner Klinge Biopharma GmbH Report the BLA Submission of FYB203 (biosimilar, aflibercept) to the US FDA
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