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Accord's aBLA for Proposed Biosimilar DMB-3115 Accepted by FDA | Venable LLP

According to a January 2024 press release from Accord BioPharma, Inc. (“Accord”), the FDA accepted Accord’s abbreviated Biologics License Application (aBLA) for DMB-3115 (ustekinumab),. ....

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FDA Accepts for Review BLA for DMB-3115 of Dong-A ST, a Proposed Biosimilar to Stelara (Ustekinumab)

FDA Accepts for Review BLA for DMB-3115 of Dong-A ST, a Proposed Biosimilar to Stelara (Ustekinumab)
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Henlius Announces U.S. FDA Acceptance of Biologics License Application for Proposed Biosimilar Trastuzumab HLX02

/PRNewswire/ Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License. ....

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Intas Enters into an Exclusive License Agreement with Meiji and Dong-A ST to commercialize DMB-3115 (Proposed Biosimilar to Ustekinumab)

Intas Enters into an Exclusive License Agreement with Meiji and Dong-A ST to commercialize DMB-3115 (Proposed Biosimilar to Ustekinumab)
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Intas inks pacts with Japanese, Korean firms for biosimilar product

Intas inks pacts with Japanese, Korean firms for biosimilar product
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