Shanghai Henlius Biotech, Organon Report FDA Has Accepted Biologic License Application For HLX14, An Investigational Biosimilar Of PROLIA/XGEVA
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Shanghai Henlius Biotech and Organon announced that the FDA has accepted the Biologic License Application for HLX14, a biosimilar of PROLIA/XGEVA. This development could impact Organon's market position in the biosimilar space.
October 30, 2024 | 10:06 am
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Organon, in collaboration with Shanghai Henlius Biotech, has received FDA acceptance for the Biologic License Application of HLX14, a biosimilar of PROLIA/XGEVA. This could enhance Organon's biosimilar portfolio.
The FDA's acceptance of the Biologic License Application for HLX14 is a significant regulatory milestone. It positions Organon to potentially expand its biosimilar offerings, which could positively impact its market share and revenue in the biosimilar sector.
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