Shanghai Henlius Biotech, Organon Report FDA Has Accepted Biologic License Application For HLX14, An Investigational Biosimilar Of PROLIA/XGEVA
Portfolio Pulse from Benzinga Newsdesk
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.
CONFIDENCE 90
IMPORTANCE 70
RELEVANCE 80