Celltrion's Proposed REMICADE® Biosimilar Recommended for Approval

by McDonnell Boehnen Hulbert & Berghoff LLP
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On February 10, 2016, the FDA's Arthritis Advisory Committee recommended approval of biologics license application ("BLA") 125544 submitted by Celltrion, Inc. for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-α antibody.  According to a press release from Celltrion, the committee voted 21-3 to recommend approval for all sought indications, including treatment of a variety of autoimmune diseases such as Crohn's disease, ulcerative colitis, and rheumatoid arthritis.  This would be the second biosimilar ever approved in the United States (U.S.) pursuant to the Biologics Price Competition and Innovation Act (BPCIA), and the first biosimilar therapeutic monoclonal antibody.  If the experience with Sandoz's ZarxioTM biosimilar is any indication, the FDA should be expected to approve the application in the next couple of months.  Marketing of the drug may be delayed, however, pending the outcome of Janssen's motion for partial summary judgment and a preliminary and permanent injunction.  A key consideration of that case is the Federal Circuit's Amgen v. Sandoz decision and its interpretation, which may delay marketing for an additional six months because the Notice of Commercial Marketing cannot be effective until approval by the FDA.

Last week, in advance of today's meetings, staff at the FDA released a briefing document in which they reported that the data submitted by Celltrion showed "that CT-P13 is highly similar to US-licensed Remicade, notwithstanding minor differences in clinically inactive components, and that there are no clinically meaningful differences between CT-P13 and US-licensed Remicade in terms of the safety, purity, and potency of the product."  Importantly, much like Sandoz's experience with Zarxio, Celltrion benefited from the fact that CT-P13 has already been approved outside the U.S. for similar indications.  For example, in the EU, South Korea, Japan, and India, Celltrion's biosimilar has been approved for all US-approved indications under the trade names Inflectra and Remsima (although no name has yet been assigned to the U.S. version of the drug).  In Canada, however, the same drug has been approved for all indications except ulcerative colitis and Crohn's Disease.  Because the development of CT-P13 occurred entirely outside of the U.S., Celltrion had to provide additional comparative data -- in order to "scientifically justify the relevance of that data by establishing an adequate scientific bridge between EU-approved Remicade, the US-licensed reference product and CT-P13."  The FDA explained that this bridging data should always include results from analytical studies, such as structural and functional data that directly compares all products, and should also include bridging PK and/or PD clinical data.

The FDA's briefing document also said that Celltrion had "provided an extensive data package to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use and potential licensure of CT-P13 for each of the seven indications for which US-licensed Remicade is currently licensed and for which CT-P13 is eligible for licensure."  Celltrion is seeking to market CT-P13 for the following indications: (1) Crohn's Disease (CD), (2) Pediatric CD, (3) Ulcerative Colitis (UC), (4) Rheumatoid Arthritis, (5) Ankylosing Spondylitis, (6) Psoriatic Arthritis, and (7) Plaque Psoriasis.  In addition, Celltrion is seeking approval for Pediatric CD, but according to the briefing, this indication is protected by orphan drug exclusivity until September 23, 2018.  Unlike in Canada, the committee recommended approval for all sought-after indications in the U.S.

Once the FDA accepts the committee's recommendation and approves Celltrion's application, it may still be at least six months before the biosimilar drug can be marketed.  Unlike Sandoz in the case of Zarxio, Celltrion provided Janssen with its aBLA after it was accepted by the FDA.  Nevertheless, according to the Complaint filed by Janssen in the U.S. District Court for the District of Massachusetts, Celltrion refused to provide the requisite "other information" required by the BPCIA, which would describe the manufacturing process.  Moreover, Celltrion served a notice of commercial marketing on February 5, 2015, indicating that it would begin selling the product as early as August 4, 2015.  Of course, even though this notice occurred after Celltrion's application was accepted, it was significantly before actual approved (especially considering the biosimilar is not yet approved).  Celltrion has responded to Janssen's injunction motions by alleging that the Notice-of-Commercial-Marketing provision of the BPCIA is not a stand-alone provision and that because it took part in the "Patent Dance," it is not required to give such notice.  While Janssen's motion is pending, the Federal Circuit will be considering the almost identical issue in the Amgen v. Apotex case, which we will preview in an upcoming post.

Nevertheless, the committee's vote today is especially significant considering the intense interest focused on biosimilar therapeutic antibodies.  Going into this meeting, there was a lot of uncertainty about just how much information the FDA would require in order for a biosimilar applicant to establish "no clinically meaningful differences" between its biosimilar drug and the reference product.  Of course, Celltrion benefited from extensive data that it had already generated outside of the U.S.  It therefore remains to be seen just how much data the FDA will require for biosimilar therapeutic antibodies that do not have such a history.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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