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Formycon Partners with MS Pharma to Commercialize FYB206 (Biosimilar, Keytruda) in the MENA Region

Shots: Formycon has entered into an exclusive licensing & supply agreement with MS Pharma for the commercialization of Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the MENA region As per the deal, Formycon will receive an upfront payment, potential development & regulatory milestones, & a significant share of regional gross profits, though…
3 days ago

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Klinge Pharma Partners with NTC to Commercialize FYB203 (Biosimilar, Eylea) in Italy

Shots: Klinge Pharma, holder of global commercialization rights for Formycon’s FYB203, has entered into an exclusive agreement with NTC to commercialize FYB203, a biosimilar version of Eylea (aflibercept), in Italy As per the deal, Klinge will receive royalties on net sales, with Formycon participating in these payments in the mid-single to low-double-digit % range, while…
November 24, 2025

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Formycon Launches Epruvy (Biosimilar, Lucentis) in the Germany

Shots:  Sandoz commercializes Epruvy (Biosimilar, Lucentis) across Germany in PFS and vial forms, following an agreement with Formycon and Bioeq   Epruvy (ranibizumab)was approved by the EMA in Sep'24 to treat severe visual impairments like nAMD and other retinopathies and is marketed by Sandoz in Germany under a Bioeq license   Epruvy is available in vials and pre-filled syringes, offering a convenient treatment option in Germany  Ref: Formycon | Image: Formycon  | Press Release Related…
November 20, 2025

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Polpharma Biologics Launches Ranivisio PFS (Biosimilar, Lucentis) in the EU

Shots: Polpharma Biologics has launched Ranivisio pre-filled syringe (PFS), a biosimilar version of Lucentis (ranibizumab) in France Bioeq AG, a joint venture of Polpharma & Formycon, develops & licenses Ranivisio PFS, with Teva holding exclusive commercialization rights in France. The drug substance is manufactured by Rezon Bio (Polpharma Biologics) in Poland Ranibizumab is a recombinant humanized…
October 22, 2025

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Actor Pharmaceuticals and Megalabs Collaborate with Formycon to commercialize FYB203 (Biosimilar, Eylea) in Australia and LATAM 

Shots:  Formycon has reported that Klinge Biopharma, holder of global rights to its FYB203 (biosimilar, Eylea), has granted exclusive commercialization rights to Actor Pharmaceuticals for Australia and to Megalabs for LATAM. Regulatory filing is submitted to Australia’s TGA, and Formycon is preparing approval applications with Megalabs for LATAM  As per the deal, Klinge will receive…
October 16, 2025

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Formycon and Klinge Biopharma sign a semi-exclusive licensing deal with Horus Pharma to commercialize the FYB203/Baiama (Biosimilar, Eylea)  

Shots:  Formycon and Klinge Biopharma have signed a semi-exclusive licensing deal with Horus Pharma to commercialize the FYB203/Baiama (Biosimilar, Eylea) in selected EC, following a similar agreement with Teva in Jan for covering major parts of the EU & Israel  Klinge will receive upfront, milestone payments, and royalties on net sales, with Formycon earning a…
September 17, 2025

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Formycon Receives the ANVISA Approval for Ranivisio (Biosimilar, Lucentis) Across Brazil

Shots: Brazil’s ANVISA has approved marketing authorization for Formycon’s Ranivisio (ranibizumab), a biosimilar to Lucentis; launch is anticipated in Q4’25 Formycon & Biomm have partnered to commercialize Ranivisio in Latin America, with approvals already granted in Peru, El Salvador, Honduras, and the Dominican Republic. Additional launches across Central and South America are planned through early…
June 6, 2025

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Fresenius Kabi
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Fresenius Kabi’s Otulfi (Biosimilar, Stelara) Receives the US FDA’s Interchangeability Designation

Shots: The US FDA has granted interchangeable designation to Otulfi, a biosimilar version of Stelara (ustekinumab) to treat mod. to sev. active Crohn's disease, ulcerative colitis, plaque PsO as well as active PsA, available in the US since March 2025 FDA approval was granted in Sep 2024 on the basis of analytical, pre-clinical, clinical & manufacturing data,…
May 20, 2025

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Formycon Reports the MHRA’s Approval of FYB203 (Biosimilar, Eylea) as Ahzantive

Shots: Following the EC approval, Formycon & Klinge Biopharma have reported the UK MHRA’s approval of FYB203, biosimilar of Eylea (aflibercept), under the brand name: Ahzantive The biosimilar is intended to treat Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal…
February 25, 2025

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Lotus Pharma & Formycon
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Lotus Pharmaceutical and Formycon Enter into a Strategic Partnership to Commercialize FYB203/Ahzantive (Biosimilar, Eylea) in APAC

Shots: Formycon has signed an exclusive license agreement with Lotus Pharmaceutical to commercialize FYB203/Ahzantive in APAC countries, including Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam, and Hong Kong. Additionally, Formycon will supply the finished product to Lotus As per the agreement, Klinge will receive upfront and milestone payments, along with royalties on Lotus’ net…
February 5, 2025

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