The US Food and Drug Administration (FDA)’s Arthritis Advisory Committee will hold a public meting on March 17, 2015, to discuss the biologics license application (BLA) of Celltrion Inc. an Incheon, South Korea-based developer of biosimilars, for a proposed biosimilar to Janssen Biotech Inc.’s Remicad (infliximab).

In August 2014, Celltrion filed the BLA for its biosimilar, Remsima through the US FDA’s biosimilar regulatory approval pathway under the Biologics Price Competition and Innovation Act of 2009 (BPCIA). In filing for US FDA approval, Celltrion said it consulted with the US FDA and conducted additional clinical trials (starting on October 2013 and lasting six months) to determine the bioequivalency of the originator products with Remsima. Specifically, Celltrion tested for pharmacokinetic/pharmacodynamic equivalency and safety equivalency for the three distinct products, the originator products sold in the US, the originator products sold in Europe, and Remsima. These additional clinical trial data, along with Celltrion's global clinical trial data, were submitted to the US FDA by Celltrion as part of its application.

Celltrion obtained approval for its biosimilar infliximab product, which uses the registered brand name of Remsima, from over 50 countries worldwide, including in Europe, Canada, and Japan. Celltrion's strategic focus is to develop and manufacture biosimilar monoclonal antibodies and novel drugs for various therapeutic areas, including oncology and autoimmune diseases. The company has 140,000 L of mammalian cell culture capacity in its facilities in Incheon. 

Cellitron is targeting several indications in its BLA application for the biosimilar. The proposed indications (uses) for this product are: (1) reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; (2) reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in adult patients with fistulizing Crohn’s disease; (3) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy; (4) reducing signs and symptoms, inducing and maintaining clinical remission and mucosal healing, and eliminating corticosteroid use in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; (5) reducing signs and symptoms and inducing and maintaining clinical remission in pediatric patients 6 years of age and older with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy; (6) in combination with methotrexate, reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis; (7) reducing signs and symptoms in patients with active ankylosing spondylitis; (8) reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage, and improving physical function in patients with psoriatic arthritis; and (9) treatment of adult patients with chronic severe (i.e., extensive and/or disabling) plaque psoriasis who are candidates for systemic therapy and when other systemic therapies are medically less appropriate.

In a separate matter, Johnson & Johnson (J&J)  announced receipt of a further action from the US Patent and Trademark Office regarding the re-examination of US Patent No. 6,284,471 (‘471) relating to Remicade, issuing a final rejection of the patent. The patent, granted in 2001, relates to anti-TNFa antibodies and assays employing anti-TNFa antibodies. In issuing a statement on February 12, 2015, J&J said that the company has 60 days to respond to this action and will do so. Currently the ‘471 patent expires in September 2018. “We believe the ‘471 patent is valid and, if necessary, will pursue all available appeals,” said the company in a statement.

Source: Federal Register and Johnson and Johnson