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Biosimilar Regulatory Updates - February 2024 | Goodwin

On January 28, 2024, Celltrion USA announced that it has completed submission of its application to the FDA for CT-P47, its proposed tocilizumab biosimilar. CT-P47 references. ....

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Accord's ABLA For Proposed Biosimilar DMB-3115 Accepted By FDA - Life Sciences, Biotechnology & Nanotechnology

According to a January 2024 press release from Accord BioPharma, Inc. ("Accord"), the FDA accepted Accord's abbreviated Biologics License Application (aBLA). ....

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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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BTS agency likely to face tougher disclosure rules

Hybe, the K-pop powerhouse behind the mega success of bands such as BTS and New Jeans, could be obliged to disclose its corporate information if the total assets of the firm and its affiliates continue to surpass 5 trillion won ($3.7 billion) by the end of this year. The combined total assets of Hybe and its 16 affiliates stood at 5.37 trillion won as of end-June, a report by corporate data research institute CEO Sco. ....

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