Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2206, a Proposed Biosimilar to Stelara® in the US and EU

The U.S. Food and Drug Administration (FDA) has accepted Bio-Thera’s Biologics License Applications (BLA) for BAT2206 as an interchangeable biosimilar to reference product Stelara® The European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for BAT2206…

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