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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…
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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…
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Bio-Thera and Avalon Pharma have signed commercialization and licensing agreements for BAT3306, a biosimilar version of Keytruda (Pembrolizumab)
As per the deal, Bio-Thera will oversee development, manufacturing, and supply of BAT3306, while Avalon Pharma will handle regulatory approvals and commercialization across Saudi Arabia and the MENA region
BAT3306 is a humanized monoclonal antibody and immune checkpoint inhibitor…
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The CHMP has recommended STADA & Bio-Thera’s Gotenfia (BAT2506; 50mg/0.5mL & 100mg/mL PFS), a biosimilar version of Simponi (golimumab), for EC approval valid in all 30 EEA states
Opinion was based on extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects, plus P-III…
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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…
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Bio-Thera Solutions & Jamjoom Pharmaceuticals have entered into a strategic agreement to commercialize BAT2306, a biosimilar version of Novartis’ Cosentyx (secukinumab) in the Middle East & Africa (MENA)
As per the deal, Jamjoom will obtain exclusive MENA rights of BAT2306 to handle regulatory submissions, market access & commercialization, while Bio-Thera will be responsible for development…
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The EC has approved Usymro (BAT2206), a biosimilar version of J&J’s Stelara (ustekinumab) for all indications of the reference product
In Oct 2024, Bio-Thera & Gedeon Richter entered a licensing & commercialization deal under which Bio-Thera will develop & manufacture Usymro, while Gedeon will commercialize it post-approval & MA Holder transfer in the EU,…
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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…
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FDA has accepted BLA for BAT2506, a biosimilar of Simponi (golimumab) for all approved doses, formulations, & indications of reference product, with a request for interchangeability (BsUFA: May 16, 2026)
BLA was backed by extensive analytical characterization & biosimilarity of BAT2506 in comparison to US & EU Simponi from P-I trial in healthy subjects,…
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Bio-Thera Solutions & SteinCares signed an agreement to commercialize a proposed dupilumab biosimilar for inflammatory diseases in Latin America
As per the deal, Bio-Thera will handle product development and supply, while SteinCares manages registration and commercialization in Latin America
Dupilumab (SC) is a fully human mAb that blocks IL-4 and IL-13 signalling pathways and…

