Samsung Bioepis & Organon Announce FDA Acceptance Of Supplemental Biologics License Application For Interchangeability Designation For HADLIMA, A Biosimilar To Humira
Portfolio Pulse from Benzinga Newsdesk
Samsung Bioepis and Organon & Co. (NYSE:OGN) have announced that the FDA has accepted for review the Supplemental Biologics License Application (sBLA) for the interchangeability designation for HADLIMA, a biosimilar to Humira. The sBLA was submitted based on clinical data from a Phase 4 study assessing the pharmacokinetic similarity between two treatment groups. The acceptance of the filing reinforces the commitment of both companies to provide better access to biologic medicines for patients in the United States.
November 07, 2023 | 10:38 pm
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The FDA's acceptance of the sBLA for HADLIMA, a biosimilar to Humira, could potentially increase Organon's market share in the biologic medicines sector. This could lead to increased revenues for the company in the short term.
The FDA's acceptance of the sBLA for HADLIMA is a positive development for Organon, as it could potentially lead to increased market share in the biologic medicines sector. This could result in increased revenues for the company in the short term. The news is highly relevant to Organon as it directly pertains to one of their products. The importance is high as the outcome of the FDA review could have significant financial implications for the company. The confidence in this analysis is high based on the information provided in the news article.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100