FDA Approves ‘Biosimilar’ of World’s Top-Selling Drug

Published November 11, 2016

The U.S. Food and Drug Administration (FDA) has decided to allow another competitor to enter the inflammatory-disease medication market by approving a biosimilar version of Humira, the world’s top-selling drug.

Biosimilar drugs have unique chemical makeups but produce “no meaningful differences from the reference product” in clinical settings, FDA’s website states.

FDA approved Amjevita, an injectable drug developed by the biotech company Amgen, on September 23. Humira, a medication primarily used to treat rheumatoid arthritis, received FDA approval in 2002 and generated $14 billion for manufacturer AbbVie in 2015.

Amjevita is the fourth biosimilar to receive FDA approval, according to an agency press release announcing the decision. FDA approved the country’s first biosimilar in 2015.

AbbVie filed a lawsuit against Amgen for infringing on the former’s patent for Humira on August 4.


Healthy Competition

Kelley Davenport, director of global communications at Amgen, says the anti-inflammatory drug market has room for competing medications.

“We believe that the FDA’s approval is an exciting step towards recognizing Amjevita as an important treatment option for patients with inflammatory diseases,” Davenport said. “The market has shown that there is already a place for all of these inflammatory products—including Humira, Remicade, and Enbrel.”

FDA approved Remicade, a biosimilar of Inflectra, in April. The agency approved Enbrel, a biosimilar of Erelzi, in August.

These drugs’ entry to the market could expand health care access, increase treatment options, and improve value for patients, Davenport says.

“We see the potential benefits to patients, providers, and payers by Amgen uniquely offering the potential opportunity to access a larger range of products in inflammation,” Davenport said.

AbbVie representatives did not respond to requests for comment.

Patent Lawsuit

AbbVie is suing Amgen in Delaware’s federal district court for allegedly violating 10 patents for Humira when manufacturing the biosimilar Amjevita.

AbbVie representatives maintain Amgen is unfairly capitalizing on AbbVie’s decades-long investment in Humira.

“This lawsuit results from Amgen’s infringement of AbbVie patents that concern AbbVie’s groundbreaking Humira,” AbbVie’s formal complaint states. “Amgen seeks to benefit from AbbVie’s substantial investment in Humira and the two decades of time, effort, investment, and innovation by AbbVie’s scientists. … [This] does not give Amgen a license to infringe AbbVie’s intellectual property.”

Although a biosimilar, Amjevita is not interchangeable with Humira. In addition to meeting FDA’s standard for biosimilars, interchangeables produce the same clinical results as the reference product, FDA’s website states.

Dr. Richard Dolinar, a practicing endocrinologist and pharmaceutical industry consultant, says accusations of patent infringement commonly accompany new drugs to the market.

“One side will always challenge the other over patent infringements,” Dolinar said. “Sometimes there are thought to be infringements, other times not. The courts ultimately decide, and the law is set up to allow for such challenges.”

Biosimilars Breed Competition

Patients benefit when new products replace existing ones that are suddenly rendered obsolete, Dolinar says.

“‘Creative destruction’ goes on constantly in the free market and is a good thing,” Dolinar said, invoking a term coined by the Austrian-American economist Joseph Schumpeter in 1942. “It results in better, cheaper, and more innovative products for the consumer.”

Biosimilars will lead to lower prices, increased access to medications, and healthier patients, Dolinar says.

“[Biosimilars] will bring competing drugs to the market at a lower price than the innovator company is currently charging, and by doing so, more patients will have access to these very expensive lifesaving and life-altering drugs,” Dolinar said. “Competition does not destroy free markets. Only government can destroy free markets.”

Michael McGrady ([email protected]) writes from Colorado Springs, Colorado.

Internet Info:

Sean Parnell, “FDA Approves First ‘Biosimilar,'” Health Care News, The Heartland Institute, March 23, 2015.

Andrew W. Mulcahy, Zachary Predmore, and Soeren Mattke, “The Cost Savings Potential of Biosimilar Drugs in the United States,” RAND Corporation, November 3, 2014.

Dr. Richard Dolinar, “‘Biosimilars’ Are ‘Biodifferent,'” The Heartland Institute, July 23, 2009.

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