Klinge Biopharma (Klinge) and Teva Pharmaceuticals (Teva) formed a semi-exclusive agreement for the commercialization of Formycon’s FYB203 biosimilar to Eylea (aflibercept) in Europe, while MS Pharma partners for the MENA (Middle East and North Africa) commercialization of FYB202, a biosimilar to Stelara (ustekinumab).
On 13 January 2025, Klinge signed a licensing agreement with Teva for the semi-exclusive commercialization of Formycon’s biosimilar candidate to Eylea (aflibercept); known as FYB203 in major parts of Europe (excluding Italy) and Israel. Concurrently, Formycon signed an agreement with Teva to supply the finished product.
Klinge holds the exclusive global commercialization rights for FYB203. In May 2024, Klinge entered into an exclusive licensing and supply agreement with MS Pharma for FYB203’s commercialization in the MENA region [1].
Under the agreement, Teva will lead the commercialization in the designated regions, marketing FYB203 under the brand name Ahzantive. Klinge will receive milestone payments and a share of product’s revenue.
Formycon will participate in these payments within a mid-single-digit to low-double-digit percentage range will receive compensation for organizing the commercial supply of Ahzantive on behalf of Klinge.
In June 2024, the US Food and Drug Administration (FDA) approved the aflibercept biosimilar FYB203/Ahzantive (aflibercept-mrbb) [2]. In November 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for its marketing authorization under the brand names Ahzantive/Baiama [3]. A final decision from the European Commission is expected in the second half of January 2025.
Separately, on 9 December 2024, Formycon and MS Pharma announced a licensing and supply agreement for the commercialization of FYB202, Formycon’s biosimilar to Stelara (ustekinumab), in the Middle East and North Africa (MENA) region.
Under this agreement, MS Pharma will license, commercialize, and locally produce FYB202 at its new biosimilars site in Saudi Arabia for the Gulf Cooperation Council (GCC) countries and MENA markets.
Formycon had previously entered into a license agreement with Fresenius Kabi in February 2023 for FYB202’s commercialization in key global markets, retaining rights to separately out-license it in specific MENA countries.
In September 2024, both the FDA and the European Commission approved the ustekinumab biosimilar FYB202 – Otulfi (ustekinumab-aauz) in the US, and Fymskina and Otulfi in Europe [4, 5]. MS Pharma plans to submit for regulatory approval in MENA countries at the earliest opportunity.
Formycon has already launched its other ophthalmic biosimilar, FYB201/Ravegza (ranibizumab), in the MENA region in early 2024. This is a biosimilar to Roche/Genentech’s Lucentis and was launched in partnership with MS Pharma [6].
Related article
Fresenius Kabi and Formycon reach agreement with J&J, Alvotech and Teva expand partnership
References
1. GaBI Online - Generics and Biosimilars Initiative. Klinge–MS Pharma and Teva–mAbxience biosimilars licence agreements [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 6]. Available from: www.gabionline.net/pharma-news/klinge-ms-pharma-and-teva-mabxience-biosimilars-licence-agreements
2. GaBI Online - Generics and Biosimilars Initiative. FDA approves third aflibercept biosimilar Ahzantive [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 6]. Available from: www.gabionline.net/biosimilars/news/fda-approves-third-aflibercept-biosimilar-ahzantive
3. GaBI Online - Generics and Biosimilars Initiative. EMA recommends approval of three aflibercept biosimilars: Ahzantive, Baiama, and Eydenzelt [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 6]. Available from: www.gabionline.net/biosimilars/news/ema-recommends-approval-of-three-aflibercept-biosimilars-ahzantive-baiama-and-eydenzelt
4. GaBI Online - Generics and Biosimilars Initiative. FDA approves biosimilars: ustekinumab Otulfi and eculizumab Epysqli [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 6]. Available from: www.gabionline.net/biosimilars/news/fda-approves-biosimilars-ustekinumab-otulfi-and-eculizumab-epysqli
5. GaBI Online - Generics and Biosimilars Initiative. EC approval for three ustekinumab biosimilars: Eksunbi, Fymskina, Otulfi [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 6]. Available from: www.gabionline.net/biosimilars/news/ec-approval-for-three-ustekinumab-biosimilars-eksunbi-fymskina-otulfi
6. GaBI Online - Generics and Biosimilars Initiative. Formycon launches biosimilar ranibizumab Ravegza in Saudi, Gedeon Richter invests [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2025 Feb 6]. Available from: www.gabionline.net/pharma-news/formycon-launches-biosimilar-ranibizumab-ravegza-in-saudi-gedeon-richter-invests
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2025 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment