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FDA Approves Amjevita, a Biosimilar of Humira

September 28, 2016
The US Food and Drug Administration approves the fourth biosimilar, a generic version of adalimumab, better known as Humira.

The US Food and Drug Administration (FDA) has approved Amjevita (adalimumab-atto), a biosimilar to the popular immunosuppressant Humira (AbbVie Inc.). Amjevita is the fourth biosimilar to be approved by the FDA, as a new wave of biosimilars begin to make their way into the pharmaceutical market.

Amjevita is approved for the following indications for adult patients:

  • moderately to severely active rheumatoid arthritis
  • active psoriatic arthritis
  • active ankylosing spondylitis (an arthritis that affects the spine)
  • moderately to severely active Crohn’s disease
  • moderately to severely active ulcerative colitis
  • moderate to severe plaque psoriasis

According to the FDA, Amjevita also is indicated for moderately to severely active polyarticular juvenile idiopathic arthritis in patients 4 years of age and older, although doctors still are recommended to review the drug’s prescribing labeling for details on prescribing information.1

Biosimilar drugs are intended as generic, cost-effective versions of existing biologic drugs, which typically have high prices. For instance, Humira, the current brand-name adalimumab drug, typically costs around $3,100 a month. The hope is that biosimilar drugs will open up a new segment of the pharmaceutical market for immunosuppressants.  

“This is important because these products (biologics) represent the fastest growing sector of pharmaceutical spending, and both patients and third party payers are struggling to pay the bills,” said G. Caleb Alexander, MD, an associate professor at the Johns Hopkins Bloomberg School of Public Health and co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, told Practical Pain Management.

Three other biologic drugs have been approved by the FDA so far, including:

  • Erelzi by Sandoz, Inc., a biosimilar of Amgen, Inc.’s etanercept (Enbrel)
  • Zarxio by Sandoz, Inc., a biosimilar of Amgen, Inc.’s filgrastim (Neupogen)
  • Inflectra by Hospira, a biosimilar of Janssen Pharmaceutica's infliximab (Remicade)

What Are Biosimilars?

The FDA designates new formulations as “biosimilar” if the drug shows “no clinically meaningful differences” from the reference product in all meaningful characteristics, like safety, purity, and potency.2 This does not mean the drugs are exact replicas of the reference formulations, however.

The FDA uses another distinction, “interchangeables,” which are generic versions of reference products that show identical clinical benefits. Because the latest drugs approved by the FDA, including Amjevita, are biosimilars and not interchangeables, there is a concern these drugs may not be as safe or effective for patients.

Some doctors even suggest the inclusion of biosimilars into the market may soon prompt clinicians to switch all their patients over to cheaper biosimilar agents. This could be seen as concerning considering there is a lack of professional consensus about biosimilar-use in immunosuppressive therapy and few studies have examined the effects of switching patients over to a biosimilar, despite the fact they were adequately responding to the reference drug, already.

The Debate About Biosimilars

Humira is considered one of the most popular, profitable drugs on the pharmaceutical market, with experts estimating AbbVie’s revenue from the drug last year climbing just over $14 billion.3

Because pharmaceutical companies that own the patents on reference products have a strong profit motive to keep biosimilars out of the market, the perception has been that biosimilars are not up to par with their reference counterparts.

“Biologic treatments represent a rapidly growing proportion of prescription drug expenditures and thus there is enormous interest in whether or not biosimilar products are truly biosimilar,” Dr. Alexander told Practical Pain Management. However, in a recent literature review, Dr. Alexander and his colleagues found numerous trials reporting biosimilars, when compared to reference products, showed similar results in their safety and effectiveness.

“Our results have important implications for many different stakeholders – not just patients and clinicians, but also payers who foot the bills and regulators who are charged with approving these products for the market,” said Dr. Alexander.

Granted, the literature review looked at studies conducted outside the US, since many countries already offer patients generic alternatives to expensive biologics. “Additional studies of the clinical performance of these (biosimilar TNF-alpha) products are needed, yet the totality of evidence supports their comparability with their branded counterparts,” said Dr. Alexander.

Unfortunately, it may take some time before these new drugs enter the market, though. AbbVie filed a lawsuit against Amgen back in August, alleging infringement on 10 of the company’s patents related to Humira. The litigation also seeks to prevent Amgen from commercial marketing of Amjevita for at least 180 days. Puzzlingly, Amgen already has made it known they intend to comply with this provision, which is set by the Biologics Price Competition and Innovation Act of 2009 (BPCIA).

This should mean Amjevita will be commercially marketed sometime in the second or third quarter of 2017, although Amgen was not available to provide an official comment on an expected release date for the drug. Amjevita also has been under review by the European Medicines Agency, which has yet to reach a decision on the drug’s approval.

Last updated on: September 28, 2016
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Biologic Generic Drugs Are as Safe and Effective, says Review