FDA Briefing Documents Offer Support for Remicade Biosimilar

Posted 05 February 2016 By Zachary Brennan

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The US Food and Drug Administration (FDA) on Friday unveiled briefing documents that could support the approval of Celltrion’s proposed Remicade (infliximab) biosimilar ahead of next Tuesday’s advisory committee hearing.

The 73-page document offers new insight into what Celltrion submitted to support the licensure of its biosimilar, known as CT-P13, for Johnson and Johnson’s reference product, and FDA officials noted that the two products are “highly similar,” though there was no mention of an interchangeability designation.

Remicade, which last year brought in more than $4 billion in US sales, is used to treat rheumatoid arthritis (RA), psoriatic arthritis, ulcerative colitis, Crohn's disease and ankylosing spondylitis (AS).

“The conclusion of the comparison of the structural and functional properties of the clinical and commercial product lots of CT-P13 and US-licensed Remicade was that they were highly similar, notwithstanding minor differences in clinically inactive components,” FDA said. The advisory committee was originally slated to be held last March, but was postponed after FDA had additional data requests pending with Celltrion.

If approved, CT-P13 would be the second biosimilar ever approved by FDA, which previously gave the go-ahead to Sandoz’s Zarxio (filgrastim-sndz) last March. Zarxio was not approved as interchangeable, meaning pharmacists cannot automatically switch the biosimilar for its reference product, Amgen’s Neupogen, without a doctor’s prescription.

The European Medicines Agency approved Celltrion’s Remicade biosimilar, known as Remsima, in 2013.

Celltrion Ad Com Details

Celltrion submitted to FDA clinical pharmacology studies, which the agency said are adequate to (1) support the demonstration of pharmacokinetic (PK) similarity between CT-P13 and Remicade, (2) establish the PK component of the scientific bridge to justify the relevance of the data generated using EU-approved Remicade, (3) justify the relevance of the PK findings from the CT-P13 clinical program to the same indications for which US-licensed Remicade is licensed.

“The results of the clinical development program indicate that the Celltrion’s data would meet the requirement for a demonstration of 'no clinically meaningful differences' between CT-P13 and the US-licensed reference product in terms of safety, purity, and potency in the indications studied,” FDA said.

The agency noted that the results from the comparative clinical efficacy, safety and PK studies, which included two different chronic dosing regimens of CT-P13 and EU-approved Remicade in two distinct patient populations (RA and AS), and a single dose in healthy subjects of CT-P13, EU-approved Remicade and US-licensed Remicade, “adequately supported the determination that there are no clinically meaningful differences between CT-P13 and US-licensed Remicade in RA and AS.”

In addition, the single transition from EU-approved Remicade to CT-P13 during long-term extension studies in RA and AS “did not result in worsening safety or immunogenicity. This would support the safety of a clinical scenario where nontreatment naïve patients undergo a single transition to CT-P13.”

In considering the totality of the evidence, the data submitted by the applicant show that CT-P13 is highly similar to US-licensed Remicade, notwithstanding minor differences in clinically inactive components, FDA added.

The agency also noted that Celltrion has provided an “extensive data package to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use suggesting that CT-P13 should receive licensure for each of the seven indications for which US-licensed Remicade is currently licensed and for which CT-P13 is eligible for licensure.”

Celltrion has an agreement with Pfizer’s Hospira to market CT-P13 in the US once it's approved.

FDA Briefing Document Arthritis Advisory Committee Meeting February 09, 2016

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Categories: Biologics and biotechnology, Clinical, Due Diligence, Government affairs, Research and development, News, US, FDA, EMA

Tags: Remicade, biosimilar, 351(k) application, clinical trials to support biosimilars

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