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Regulatory Focus™ > News Articles > FDA Approves Second Biosimilar, First mAb Biosimilar for US Market

FDA Approves Second Biosimilar, First mAb Biosimilar for US Market

Posted 05 April 2016 | By Zachary Brennan 

FDA Approves Second Biosimilar, First mAb Biosimilar for US Market

The US Food and Drug Administration (FDA) on Tuesday approved the second biosimilar in the US, known as Inflectra (infliximab-dyyb), which is biosimilar to Janssen Biotech’s Remicade (infliximab).

Celltrion and Pfizer’s Inflectra has been approved as biosimilar, not as an interchangeable product, meaning in a number of states, pharmacists will not be able to automatically switch patients from Remicade to Inflectra. This is the first monoclonal antibody biosimilar approved by FDA. The same biosimilar was approved in the EU in 2013.

A Janssen spokeswoman told Focus that patents for Remicade, first approved by FDA in 1998, remain valid and enforceable until September 2018 and a commercial launch of Celltrion’s infliximab-dyyb  in advance of this date would be an infringement of its patents, and Janssen intends to defend its intellectual property rights.  

Inflectra is approved and can be prescribed by a health care professional for the treatment of:

  • adult patients and pediatric patients (ages six years and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy;
  • adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to conventional therapy;
  • patients with moderately to severely active rheumatoid arthritis in combination with methotrexate;
  • patients with active ankylosing spondylitis (arthritis of the spine);
  • patients with active psoriatic arthritis;
  • adult patients with chronic severe plaque psoriasis.

As expected, Inflectra is not indicated for pediatric UC or Crohn's disease as Remicade's pediatric UC indication is protected by orphan exclusivity through 23 September 2018.

Partha Roy, Ph.D., Director of Integrated Product Development at Parexel Consulting, which helped Pfizer and Celltrion win approval for Inflectra, told Focus that getting approval of Inflectra as an interchangeable biosimilar "is a sequential process" and that "a path is set for an increasing number of approved treatment options, a benefit to patients and the healthcare system."

FDA’s approval of Inflectra is based on review of evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates Inflectra is biosimilar to Remicade.

A biosimilar product can only be approved by FDA if it has the same mechanism of action (but only to the extent that the mechanism of action is known for the reference product), route(s) of administration, dosage form(s) and strength(s) as the reference product, and only for the indication(s) and condition(s) of use that have been approved for the reference product.

The facilities where biosimilars are manufactured must also meet FDA’s standards and Inflectra will be produced at Celltrion's manufacturing facility in Incheon, Korea. A panel of experts backed Inflectra's approval in February.

The approval comes more than a year since FDA approved the last biosimilar -- Sandoz' Zarxio (filgrastim-sndz), which is biosimilar to Amgen's Neupogen, and unlike Inflectra used a meaningful suffix as part of its biosimilar name.

Story updated on 4/6/16 with comments from Janssen and Parexel.

FDA Approval Announcement

Inflectra Label

Approval Letter

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