Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2206, a Proposed Biosimilar to Stelara® in the US and EU
Bio-Thera's BAT2206, a biosimilar to Stelara®, has its BLA accepted by the FDA and MAA by the EMA, marking a milestone as the first ustekinumab biosimilar from a Chinese company submitted for approval in the US and EU. The applications are supported by comprehensive analytical, non-clinical, and clinical data.
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Bio-Thera Solutions Announces Regulatory Filing Acceptance for BAT2206, a Proposed Biosimilar to Stelara® in the US and EU
Bio-Thera's BAT2206, a biosimilar to Stelara®, has its BLA accepted by the FDA and MAA by the EMA, marking a milestone as the first ustekinumab biosimilar from a Chinese company submitted for approval in the US and EU. The applications are supported by comprehensive analytical, non-clinical, and clinical data.