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Bio-Thera Expands Collaboration with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) in India 

Shots:  Bio-Thera Solutions expanded its partnership with Intas Pharmaceuticals for BAT2506, a proposed biosimilar of Simponi (golimumab), through an exclusive commercialization and licensing agreement for India  BAT2506 is a proposed golimumab biosimilar by Bio-Thera. Golimumab, a human IgG1 monoclonal antibody, targets TNF-α to reduce key inflammatory markers such as CRP, IL-6, ICAM-1, MMP-3, and VEGF. The reference drug is approved…
March 23, 2026

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Cytiva and Yoshindo Collaborate to Strengthen Domestic Biosimilar Manufacturing through their FlexFactory Contract in Japan 

Shots:  Cytiva and Yoshindo sign a FlexFactory contract to support the establishment of domestic biosimilar drug substance manufacturing in Japan. The investment is partly supported by Japan’s MHLW  Yoshindo plans to supply biosimilars from its Toyama plant starting in 2028, supporting a stable and affordable biologics supply in Japan  Cytiva’s FlexFactory platform uses modular bioprocessing technologies to support faster transition from facility design to GMP…
March 23, 2026

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Mochida Pharmaceutical and AYUMI Pharmaceutical Receives Manufacturing & Marketing Approval for Tocilizumab BS MA (Biosimilar, Actemra) in Japan  

Shots:  The company has received manufacturing and marketing approval in Japan for tocilizumab BS MA, a biosimilar version of Actemra (tocilizumab)   Tocilizumab BS MA, a biosimilar jointly developed by Mochida Pharmaceutical and Gedeon Richter. Under their agreement with AYUMI Pharmaceutical, Mochida will supply the product, while AYUMI will handle its sales in Japan   Mochida Pharmaceutical…
March 23, 2026

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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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Samsung Bioepis Partners with Sandoz for Up to Five Biosimilar Candidates

Shots: Samsung Bioepis has entered into a global license, development & commercialization agreement with Sandoz for up to five biosimilars, incl. SB36 (preclinical), a biosimilar version of Entyvio (vedolizumab) Samsung Bioepis will handle development, manufacturing & regulatory filings, while Sandoz will lead commercialization globally (excl. China, Hong Kong, Taiwan, Macau & Republic of Korea) The…
March 18, 2026

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Celltrion
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Celltrion Introduces Remsima IV Liquid Formulation (Biosimilar, Remicade) in the EU 

Shots:  Following the EU approval of Remsima IV in Nov’25, Celltrion launched Remsima IV, a biosimilar version of Remicade (Infliximab), across Europe  Celltrion has filed and secured patents for the Remsima liquid formulation across most EU countries, including key markets such as the UK, Germany, and France  The Remsima liquid formulation adds to existing IV (100 mg lyophilized) and SC options, aligning with clinical demand in Europe…
March 11, 2026

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Gan & Lee Pharmaceuticals Receives the CHMP Positive Opinion for Bysumlog and Dazparda (Biosimilar, Humalog and NovoRapid) 

Shots:  The CHMP has recommended marketing authorization for Bysumlog (insulin lispro) and Dazparda (insulin aspart), a biosimilar version of Humalog and  NovoRapid, respectively, across all 30 EEA states  Opinion was supported by P-I demonstrating biosimilarity and comparable safety of Bysumlog vs Humalog and Dazparda vs NovoLog/NovoRapid.  Gan & Lee Pharmaceuticals signed a development, license, and commercialization agreement with Sandoz for three insulin biosimilars: glargine, lispro, and aspart. Upon approval, Sandoz…
February 27, 2026

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Gedeon Richter
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Gedeon Richter Receives the CHMP Positive Opinion for Tuyory (Biosimilar, RoActemra) 

Shots:  The CHMP has recommended marketing authorization for Gedeon Richter’s Tuyory, a biosimilar version of RoActemra (Tocilizumab)  Tuyory (tocilizumab) inhibits IL-6 signaling and is indicated for rheumatoid arthritis, juvenile idiopathic arthritis (including polyarthritis), giant cell arteritis, cytokine release syndrome, and COVID-19. It is available in both IV and SC forms, with dosing and presentations matching the reference product  Tuyory was co-developed by Gedeon Richter and Mochida Pharmaceutical …
February 27, 2026

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