January 16, 2018 / 6:09 AM / 7 months ago

BRIEF-FDA accepts Novartis submission of biosimilar version of Humira

Jan 16 (Reuters) - Novartis AG:

* SANDOZ REGULATORY SUBMISSION FOR PROPOSED BIOSIMILAR ADALIMUMAB ACCEPTED BY FDA

* US FOOD AND DRUG ADMINISTRATION (FDA) ACCEPTED ITS BIOLOGICS LICENSE APPLICATION (BLA), SUBMITTED UNDER THE 351 (K) PATHWAY, FOR PROPOSED BIOSIMILAR ADALIMUMAB TO THE REFERENCE MEDICINE, HUMIRA

* ‍DATA PACKAGE PROVIDED IS EXPECTED TO DEMONSTRATE THAT SANDOZ PROPOSED BIOSIMILAR ADALIMUMAB MATCHES REFERENCE BIOLOGIC MEDICINE IN TERMS OF SAFETY, EFFICACY AND QUALITY​ Source text for Eikon: Further company coverage: (Reporting By Michael Shields)

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