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INSIGHTS+

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…
4 days ago

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NEWS

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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Bio-Thera Solutions Expands its Partnership with STADA for BAT1806 (Biosimilar, RoActemra)
NEWS

STADA & Bio-Thera Receive the EC approval for Gotenfia (Biosimilar, Simponi)

Shots: The EC has approved STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), in all 30 EEA states, with launch preparations ongoing Approval was based on extensive analytical, non-clinical & clinical data demonstrating biosimilarity of BAT2506 to Simponi In May 2024 deal, STADA obtained exclusive commercial rights to Gotenfia…
February 16, 2026

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Accord BioPharma Receive the US FDA’s Approval for Osvyrti and Jubereq (Biosimilar, Prolia and Xgeva)   

Shots:  The US FDA has approved Osvyrti and Jubereq biosimilars to Prolia and Xgeva. Accord is anticipated to commercialize OSVYRTI and JUBEREQ in 2026   The approvals were supported by a P-I study showing JUBEREQ and Xgeva had comparable PK, and a P-III study in postmenopausal women with osteoporosis demonstrating that OSVYRTI and Prolia are highly similar with no clinically meaningful differences in PK, PD, safety, or efficacy  Intas has an exclusive…
November 20, 2025

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Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across Canada

Shots: Bio-Thera Solutions has entered into an exclusive commercialization & license agreement with Intas Pharmaceuticals for BAT2506, a biosimilar version of Simponi (golimumab), for Canada The agreement expands their Feb 2025 deal, under which Intas holds US commercialization rights for BAT2506, while Bio-Thera handles its development & manufacturing BAT2506 is an IgG1 monoclonal antibody that targets…
October 10, 2025

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Bio-Thera Solutions Expands its Partnership with STADA for BAT1806 (Biosimilar, RoActemra)
NEWS

Bio-Thera Solutions Expands its Partnership with STADA for BAT1806 (Biosimilar, RoActemra)

Shots: Bio-Thera & STADA have expanded their partnership to BAT1806, a biosimilar version of Roche’s RoActemra (tocilizumab), whose 20mg/ml vial formulation received EMA’s approval in Jun 2024 for several arthritic conditions As per the deal, STADA will obtain exclusive rights to commercialize BAT1806 in the EU, UK, Switzerland & select other countries under its own marketing…
August 25, 2025

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Accord BioPharma launches Imuldosa (Biosimilar, Stelara) PFS at the lowest WAC  

Shots:  Accord BioPharma, a division of Intas Pharmaceuticals, has launched Imuldosa (ustekinumab-srlf), a biosimilar to Stelara  The launch includes a $0 co-pay program for eligible pts with plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis  Through an exclusive deal with Bio-Thera Solutions, Accord plans to introduce BAT2506, a biosimilar to Simponi, to the U.S.…
August 18, 2025

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Key Biosimilars Events of March 2025
INSIGHTS+

Key Biosimilars Events of March 2025

Shots:        Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency         Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients         Bio-Thera Collaborates with Dr. Reddy’s for the Commercialization of BAT2206 & BAT2506…
April 8, 2025

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