In A Blow To AbbVie Inc (ABBV) Humira, Market For Biosimilars Opened Wide 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.
I'm unclear on how much Humira revenue is actually derived from the UK. International in 2016 was $5.6 Billion or roughly a 1/3 of total ($16.0 Billion) revenue. Nevertheless, it appears cracks in the patent estate are happening and will likely be repeated in the US.
The scope of the revenue stream with both a large international stream and very large domestic revenue suggests that it might be advantageous for MNTA to act like a movie studio and sell off international rights to generate cash while focusing domestically. There are likely many possibilities for M923 - depending of course on interchangeability data, although this may be less important in the EU as there is not a standard for it.
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