Monday, March 06, 2017 6:01:14 PM
March 6, 2017
Excerpts:
This now means that Bioepis can begin working on commercializing Humira’s biosimilar, SB5, in European markets. SB5 has already received approval from the continent’s drug regulator, the European Medicines Agency.
Samsung had indicated that it intended to introduce its biosimilar in European markets as soon as the basic patent held on Humira had expired. The basic patent is set for an October 2018 expiry date.
Prior to the start of the trial, AbbVie Inc (NYSE:ABBV) had proposed that the dispute be settled through negotiations between the two parties and not through the court system. Samsung Bioepis, however, objected, preferring a definite court ruling instead.
Humira has gone on to become the best-selling treatment of all time. In 2015, Humira generated sales of over $14 billion.
The U.S. Food and Drug Administration has already approved a biosimilar of Humira that is manufactured by Amgen, Inc. (NASDAQ:AMGN) known as Amjevita and, as promised, AbbVie’s CEO is expected to head to court over the matter claiming infringement of patents.
http://www.insidermonkey.com/blog/in-a-blow-to-abbvie-inc-abbv-humira-market-for-biosimilars-opened-wide-563906/
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