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INSIGHTS+

Key Biosimilars Events of May 2026 

Shots:  May 2026 saw strong biosimilar momentum with key approvals including Bevqolva (Health Canada), Langlara and Immgolis/Immgolis Intri (US FDA), Bysumlog and Dazparda (EC), and Eyzanfy (MFDS), expanding competition across oncology, diabetes, immunology, and ophthalmology.  Strategic progress continued with Henlius’ FDA IND clearance for HLX05-N, alongside partnerships between IQVIA–Kexing Biopharm and Polpharma–Tuteur, supporting global development and commercialization efforts.  Commercialization accelerated through the EU launches of FYB203 and Opuviz, as well as Samsung Bioepis’ ustekinumab biosimilar launch in Japan,…
June 2, 2026

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Formycon and Klinge Biopharma Launch FYB203 (Biosimilar, Eylea) in the EU 

Shots:  Formycon and licensing partner Klinge Biopharma have reported the EU launch of FYB203, a biosimilar version of Eylea 2mg (aflibercept)  FYB203 is now available in the EU as a PFS under the brand names Ahzantive and Baiama. The launch began on May 15, 2026, in key markets including Germany, France, and Italy, with further expansion across Central and Eastern Europe planned…
May 19, 2026

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Key Biosimilars Events of March 2026 

Shots:  Regulatory momentum remained strong, with key biosimilar launches and approvals including Celltrion’s Remsima IV (EU) and Avtozma SC (US), Teva’s FDA-approved Ponlimsi, Japan’s approval of tocilizumab BS MA by Mochida Pharmaceutical and AYUMI Pharmaceutical, and IND clearance for HLX18 by National Medical Products Administration.  Strategic partnerships expanded access, led by Samsung Bioepis–Sandoz collaboration, Formycon’s aflibercept settlement deal with Regeneron Pharmaceuticals and Bayer, and Bio-Thera…
April 7, 2026

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NEWS

Formycon Inks Settlement and Licensing Deal with Regeneron & Bayer for Commercialization of FYB203 (Biosimilar, Eylea)  

Shots:  Formycon has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of FYB203, a biosimilar version of Eylea 2 mg (aflibercept 0.05 ml of 40 mg/mL solution), in the EU  Under the agreement, both products may launch in the EU and other regions, including LATAM and Asia-Pacific, from May 2026. Earlier, in October 2025, Formycon secured…
March 19, 2026

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NEWS

Formycon and Zydus Lifescience Report Successful Clinical Development of FYB206 (Biosimilar, Keytruda) 

Shots:  Formycon & Zydus Lifescience has reported that the pivotal Dahlia PK study of FYB206, a biosimilar version of Keytruda (pembrolizumab), has met its 1EP   The multicenter PK study showed bioequivalence of FYB206 (pembrolizumab) to Keytruda   Zydus Lifesciences has exclusively in-licensed FYB206, a proposed biosimilar to Keytruda (pembrolizumab), from Formycon for the US and Canada   Ref: Zydus Lifesciences | Image: Zydus Lifesciences and Formycon | Press Release  Related…
February 25, 2026

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Lotus Pharmaceutical Partners with Formycon to Commercialize FYB206 (Biosimilar, Keytruda) across APAC Region

Shots: Formycon & Lotus have reported the conclusion of their exclusive license agreement for Formycon’s FYB206, a biosimilar version of Keytruda (Pembrolizumab), in the APAC market Upon closing, Formycon will receive an upfront payment, plus potential development & regulatory milestone payments, & a share of gross profits after launch, while retaining responsibility for manufacturing &…
February 12, 2026

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Key Biosimilars Events of December 2025  

Shots:        Regulatory and launch momentum accelerated globally in late 2025, with multiple FDA approvals, CHMP positive opinions, and EU/US launches for biosimilars referencing blockbuster biologics such as Prolia/Xgeva, Lucentis, Eylea, Xolair, Stelara, Simponi, Neulasta, Humira, Opdivo, and Keytruda—broadening patient access across oncology, immunology, ophthalmology, bone health, and allergy indications  Leading biosimilar developers including Samsung Bioepis, Celltrion, Alvotech, Formycon,…
January 6, 2026

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NEWS

Formycon Receives the US FDA Approval for Nufymco (Biosimilars, Lucentis)

Shots:  The US FDA has approved Nufymco (ranibizumab-leyk), an interchangeable biosimilar of Lucentis, with Zydus serving as its commercialization partner in the US  Nufymco is an interchangeable Lucentis biosimilar developed by Formycon, approved for the treatment of wet AMD, diabetic macular edema, diabetic retinopathy, retinal vein occlusion-related macular edema, and myopic choroidal neovascularization  Zydus secured exclusive US and Canada rights to Formycon’s Keytruda…
December 23, 2025

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Formycon Partners with Zydus to Commercialize FYB206 (Biosimilar, Keytruda) in the US and Canada

Shots: Formycon has entered into an exclusive licensing & supply agreement with Zydus Lifesciences Global FZE, UAE (Zydus' subsidiary) to commercialize Formycon’s FYB206, a biosimilar version of Merck’s Keytruda (pembrolizumab), in the US & Canada As per the deal, Formycon will be responsible for development, registration, manufacturing & supply of the product, while Zydus Lifesciences…
December 10, 2025

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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…
December 4, 2025

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