$5B in Humira sales at stake with Amgen EU approval
- Amgen has hooked its first EU biosimilar approval with market authorization for Amgevita (biosimilar adalimumab), a biologic copy of AbbVie's blockbuster Humira (adalimumab). It got the ok for all nine Humira indications—a wide variety of inflammatory disease, in both adults and children.
- The approval is based on two Phase 3 trials, one in plaque psoriasis and the other in rheumatoid arthritis, as well as other pharmacokinetic data confirming its biosimilarity to Humira. The results showed no clinically meaningful differences, or differences in safety and immunogenicity.
- Amgen hasn't commented on timelines for either U.S. or European launches of the biosimilar. The drug, known as Amjevita in the U.S., got approval from the Food and Drug Administration in September 2016.
AbbVie reported 2016 Humira sales of $10.4 billion in the U.S. and $5.6 billion in the rest of the world. While Humira's EU sales aren’t as large as the U.S. market, Humira's net revenue is over 65% of AbbVie's overall adjusted net revenues, and so any inroads into Humira's revenue is going to have an impact on the company's topline. In its third quarter earnings call last year, AbbVie remained upbeat about the European biosimilar threat, predicting continuing increases in Humira and citing the modest impacts of Pfizer and Celltrion's Inflectra, as well as Novartis's Enbrel on European sales of Humira.
Amgevita got a thumbs-up from the European Medicines Agency along with seven other biosimilars in January this year. Others were Pfizer's Xeljanz (tofacitinib), Therakind's Jylamvo (methotrexate), Amgen's Solymbic (adalimumab), GlaxoSmithKline's Rolufta (umeclidinium), Eli Lilly's Tadalafil Lilly (tadalafil), JensorR+'s Yargesa (miglustat), and Hospira U.K.'s Daptomycin Hospira (daptomycin).
The adalimumab biosimilar was approved in the U.S. as Amjevita in September 2016, but its launch has been held up in the U.S. by patent litigation, and a U.S. launch in 2017 still doesn't look particularly likely.
In the fourth quarter call, AbbVie CEO Richard Gonzalez responded to questions about biosimilars and interchangeability, saying, "We don't believe based on what we know that any of the single switch studies that are being done now would meet [the FDA's standard]. But we'll have to see how the competitive dynamics play out as people look at this and start to design programs in order to try to achieve interchangeability. I think we'll have to see how that plays out over time."
- Amgen Statement
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