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Regulatory Approval Biologics

Goodwin

Regulatory and Commercial Updates on Bio-Thera’s BAT2506 (golimumab)

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​​​​​​​On February 10, 2025, Bio-Thera Solutions, Ltd. announced that they entered into an exclusive licensing agreement with Intas Pharmaceuticals Ltd. to commercialize BAT2506 (golimumab), Bio-Thera’s proposed biosimilar of...more

Goodwin

Biosimilar Regulatory Approval Updates

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​​​​​​​Teva announced today that the European Commission has granted marketing authorization for RANIVISIO, a biosimilar ranibizumab, for the treatment of age-related macular degeneration (AMD). Teva entered into a strategic...more

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