Earlier today, the U.S. Food and Drug Administration approved Celltrion's application to market Inflectra, a biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-α antibody. This marks only the second biosimilar approved by the FDA pursuant to the BPCIA, and only the first to approve a therapeutic monoclonal antibody. Biologics License Application ("BLA") 125544 was submitted by Celltrion, Inc. on August 8, 2014, and the FDA's Arthritis Advisory Committee recommended its approval on February 9, 2016 (see "Celltrion's Proposed REMICADE® Biosimilar Recommended for Approval"). Of course, the date on which Celltrion will be able to market this drug is unclear, because of the uncertainty surrounding the Notice-of-Commercial-Marketing provision of the BPCIA. Because the Amgen v. Sandoz case suggested that this provision is mandatory in all cases, it may be at least 180 days before Inflectra will hit the market.
According to a press release on the FDA website, Inflectra is approved to be prescribed for the treatment of the following conditions:
• 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 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.
The FDA indicated in this press release that its approval was:
[B]ased 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. Inflectra has been approved as biosimilar, not as an interchangeable product.
Much like Sandoz's experience last year with Zarxio, Celltrion certainly benefited from the fact that its biosimilar antibody had already been approved outside the U.S. for similar indications. For example, in the EU, South Korea, Japan, and India, it has been approved for all US-approved indications under either the trade name Inflectra and Remsima. It has also been approved in Canada for all indications except ulcerative colitis and Crohn's Disease.
Nevertheless, even though the biosimilar was approved by the FDA today, Celltrion represented to the U.S. District Court for the District of Massachusetts on March 22, 2016 that it would "not sell in the United States a proposed biosimilar version of Janssen's Remicade for use by doctors or patients before June 30, 2016," the date on which one of the asserted patents will expire. Moreover, a motion for a preliminary and permanent injunction is still pending in that Court, which could delay the sale of the drug even longer. Celltrion had initially served a notice of commercial marketing on February 5, 2015, indicating that it would begin selling the product as early as August 4, 2015 (which it obviously did not do). Celltrion did provide Janssen with its aBLA after it was accepted by the FDA, but (according to Janssen's Complaint) Celltrion refused to provide the requisite "other information" required by the BPCIA, which would have described the manufacturing process. In addition, Celltrion has taken a similar position as Apotex in the Amgen v. Apotex case that the Notice-of-Commercial-Marketing provision of the BPCIA is not a stand-alone provision. Therefore, according to Celltrion, because it took part in the "Patent Dance," it is not required to give such notice. The Federal Circuit heard oral argument in the Amgen v. Apotex case yesterday, so if a decision comes out in the next six months, it could be determinative in this case. We will report on the Amgen v. Apotex oral argument in an upcoming post.
