Humira facing building pressure in EU as Samsung, Biogen get nod for biosimilar

Samsung Bioepis
Samsung Bioepis has had its Humira biosimilar Imraldi recommended by the EMA for approval in Europe.

A new flank is opening up in the assault on Humira, the world’s best-selling drug, as the European Medicines Agency today recommended approval of Imraldi, a Humira biosimilar from Samsung Bioepis and Biogen.  

If it wins the expected approval of the European Commission, it will be the second approved biosimilar in Europe of the $16 billion behemoth. Amgen’s version, Amjevita, was approved in the EU in March after snagging an FDA approval last year.

Samsung, which announced the recommendation, said Imraldi will be marketed in the EU by partner Biogen. The drug is recommended for approval in all of the available indications, which include rheumatoid arthritis, juvenile idiopathic arthritis and psoriasis.

AbbVie had international sales of Humira last year of $5.6 billion, up 4%. Sales in the U.S. were $10.4 billion, up 24%.

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AbbVie, which gets about 60% of its revenues from Humira, has been frantically throwing up legal hurdles to the copies. It has said it believes it can hold off copies until 2022. The milestone for Imraldi comes after a March decision by a U.K. court found that med’s European patents for rheumatoid arthritis, psoriasis and psoriatic arthritis indications could not be enforced.

RELATED: Amgen's Humira biosim, Amjevita, passes FDA milestone on long road to market

AbbVie has sued Amgen in the U.S. over its Humira biosimilar. The Thousand Oaks, California biotech so far has held off on an at-risk launch: CEO Robert Bradway has said the copycat won’t hit the U.S. scene before November.

Coherus BioSciences in May was able to defeat AbbVie’s '135 methods patent, considered cornerstone to its IP protection, but there are other patents that still have to be overcome.

RELATED: Key Humira patent goes down via IPR—but biosims makers shouldn't celebrate yet, analysts warn

Even with biosimilars nipping at its heels, drug sales projections from analyst group Evaluate show Humira continuing to be the top-selling drug through 2022 with a projected $15.9 billion in sales that year.