FDA Approves Amgen’s Biosimilar Versi...
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Oct
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Sandeep Singh Dhillon
FDA Approves Amgen’s Biosimilar Version of Humira – Wall Street Journal
Pharma News, Pharma Notables
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U.S. regulators approved Amgen Inc.’s copy of the AbbVie Inc.’s anti-inflammatory treatment, Humira, which was the second-biggest selling drug in 2015.

Amgen’s drug, known as Amjevita, is only the fourth so-called biosimilar—which are copies of complex biotech medicines—approved by the U.S. Food and Drug Administration. Biosimilars were authorized as part of the federal health-care overhaul to reduce spending on such biotech drugs, much like generics have cut the costs of pills.

Amgen shares added a dime to $174.90 in after-hours trading, while AbbVie added 2 cents to $65.

Last month, AbbVie filed a patent-infringement lawsuit against Amgen, seeking to block sales of the biosimilar. The lawsuit alleged that Amgen violated AbbVie’s patents, and the suit asked the court to keep the copy off the market if it gains FDA approval.

Sean E. Harper, executive vice president of research and development at Amgen, called the FDA move “an exciting accomplishment.”

A spokeswoman for AbbVie said in an email that the approval was “anticipated” and reiterated that “AbbVie and Amgen are currently in litigation over AbbVie’s Humira-related intellectual property.”

Humira, which has a list price of $53,260 a year, had $8.4 billion in sales last year and accounts for about 60% of AbbVie’s revenue.

In a prepared statement, the FDA said Amgen’s Amjevita proved to be a biosimilar of Humira based on clinical safety and effectiveness data, among other metrics.

Biosimilars, long available in other markets, were first approved in the U.S. in March 2015. It remains unclear if the new biosimilars are generating the degree of cost savings that some expected.

“The biosimilar pathway is still a new frontier and one that we expect will enhance access to treatment for patients with serious medical conditions,” said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, on Friday.



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