Biogen, Samsung Humira copy wins EU approval

A second biosimilar of AbbVie's Humira, the world's top-selling drug at $16 billion, has been approved in Europe.

The forces of competition are mounting against Humira, the world’s best-selling drug at $16 billion in global sales, with approval of a second biosimilar in Europe. 

The European Commission gave its approval on Thursday to Imraldi, which was developed by Samsung Bioepis, the joint venture between Biogen and South Korea’s Samsung Biologics. In March, the EU gave a green light to Amgen’s Amjevita, which has also been approved in the U.S.

Imraldi was approved for all of the available indications, including rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, psoriasis, pediatric plaque psoriasis, Crohn’s disease and ulcerative colitis and uveitis.

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The JV has said that Imraldi will be marketed in Europe by Biogen but didn’t say when it might launch. Imraldi is the third biosimilar approval for Samsung Biopsis in the EU and with its OK, Biogen and Samsung now have EU approvals for three of the top-selling RA drugs in the world, Remicade, Enbrel and Humria. 

AbbVie gets about 60% of its revenues from Humira, which last year recorded $10.4 billion in U.S. sales, up 24%, and $5.6 billion in the rest of the world, up 4%. The company has made every legal effort to postpone the patent loss inevitability, hoping to hold off copies until at least 2022.

RELATED: Pro-Samsung U.K. court ruling hurts AbbVie's defense against Humira biosims

Those efforts were blunted earlier this year when a U.K. court found that the 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

Even though Amgen’s Amjevita has won an FDA approval, the California-based company has so far held off on an at-risk launch as litigation by AbbVie plays out. But the legal efforts by competitors wanting to get a piece of Humira’s very large pie are chipping away at AbbVie’s defenses. Coherus BioSciences in May was able to defeat AbbVie’s '135 methods patent, considered cornerstone to its IP protection, although 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

Despite the fact that biosimilars are expected to make it into the EU and U.S. before long, perhaps yet this year, the entrenched Humira is expected to hold on to a very big piece of the action for some years yet. Drug analyst group Evaluate has projected that it will continue to be the global sales leader through 2022 with a projected $15.9 billion in sales that year.

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