Mylan, Fujifilm score EU thumbs-up for Humira biosimilar, putting more pressure on AbbVie

AbbVie and its investors have been fretting over the potential impact of biosimilar competition to Humira—the world’s top-selling drug, with more than $18 billion a year in sales—and now they have another contender to worry about.

Mylan and Fujifilm Kyowa Kirin Biologics have nabbed approval from the European Commission for their biosimilar version of the drug, Hulio. The companies will start rolling it out in Europe on Oct. 16, they said in an announcement.

Hulio was the fifth biosimilar version of Humira given the go-ahead in the EU, following earlier approvals granted to Amgen, Sandoz, Boehringer-Ingelheim and Samsung Bioepis—all of which are expected to launch next month.

Biosimilars represent "a huge opportunity in Europe," said Jacek Glinka, president of Mylan Europe, in the statement. Humira alone has brought in $4.4 billion in sales in the last 12 months, according to health data provider IQVIA.

The entry of a fifth biosimilar player could feed growing fears that the impact of Humira competition in Europe might be bigger than AbbVie CEO Rick Gonzalez and his colleagues predicted. They told analysts to expect sales of the product in Europe to drop no more than 20% by the end of 2019.

If that were to hold true, the total worldwide sales of Humira would continue to soar, hitting or even surpassing $21 billion in 2022, before bowing to biosimilar competition in the U.S. the following year, most analysts estimate.

But lately, some analysts have started questioning that optimism. In August, Credit Suisse released a report predicting that sales of Humira would begin falling in 2020, shrinking to $18 billion in 2022 and then to $16.4 billion in 2023.

There’s good reason to be cautious, considering the precedent set by Enbrel and Remicade, which compete in the same market Humira does. All three products are prescribed to treat Crohn’s, rheumatoid arthritis and other inflammatory diseases. And biosimilar competition has not been kind to Enbrel and Remicade.

Sales of Remicade have dropped 66% in Europe in the three years since the first biosimilar version of the product was approved there, while Enbrel has dropped a third since 2016, when cheaper rivals started hitting the market.

For Mylan, the EU approval of Hulio is a much-needed piece of good news. The company’s best-selling EpiPen emergency allergy shot is in danger of losing its lead, as the company grapples with a manufacturing shortfall. To make matters worse, three epinephrine makers are gearing up to launch rival products. That’s only compounding the challenges for Mylan CEO Heather Bresch, who is still taking heat for jacking up EpiPen’s price in 2016.

Hulio alone won’t be enough to solve Mylan’s problems, of course. The company warned in its second-quarter earnings release last month that its revenues for this year will be flat, at $11.25 billion to $12.25 billion. It has assembled a committee to evaluate strategic "alternatives" for the company—and that group will "be looking at everything," Bresch said, to improve Mylan’s prospects.

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