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Leading Drugs Under Fire In 2015

Biologics: Biosimilar competition emerged for the first time in U.S. market

by Ann M. Thayer
December 7, 2015 | A version of this story appeared in Volume 93, Issue 48

High-priced, big-selling biologic drugs lost a bit of their luster this year as competition from the first biosimilar approved in the U.S. emerged. In September, Sandoz, the generic drug arm of Novartis, launched Zarxio, a copycat version of Amgen’s white-blood-cell stimulant Neupogen.

Zarxio may be the first, but it certainly isn’t the last. When granting approval in March, the Food & Drug Administration indicated that more biosimilars were “on the way.” At least five versions of four products await U.S. approval, and more than 50 are in development.

“Biosimilars are likely to create greater competition in the medical marketplace,” said Leah Christl, FDA’s associate director for therapeutic biologics. She sees them as new, lower-priced alternatives to existing products.

Indeed, biosimilar competition is expected to reduce U.S. prices by as much as 35% on the basis of experiences in Europe, Canada, Japan, and Australia, where dozens of biosimilars have been sold for about a decade.

In all markets, biosimilar competition is introducing a new dynamic to drug sales. Over the past decade, biologics have accounted for up to 40% of drug approvals and have risen to a level of about 25% of overall sales, according to the market research firm EvaluatePharma. In 2015, six biologics were among the top 10 selling drugs, and five of these will lose patent protection by 2019.

Biologics with an estimated $80 billion in combined sales will lose patent protection through 2020, EvaluatePharma reports. This year marked just the start, with $10 billion worth coming under fire.

Nevertheless, AbbVie’s anti-inflammatory antibody Humira is predicted to remain the world’s top-selling drug for another few years. That’s despite fast growth for Gilead Sciences’ high-priced hepatitis C treatment Harvoni and at least three biosimilar versions of Humira in late-stage development. Another, from Amgen, is now before FDA for approval.

A table of Top 10 leading products.


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