FDA Approves First mAb Biosimilar

FDA approved the first monoclonal antibody (mAb)-based biosimilar on April 5, 2016. Celltrion and Pfizer's Inflectra (infliximab) was given the green light for all indications, except for Remicade’s indication for pediatric ulcerative colitis, which is still covered by orphan drug exclusivity until September 23, 2018. Inflectra is approved to treat a range of inflammatory conditions, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

Following the rules outlined in FDA's recent draft guidance on biosimilar labeling, the common name of the product is infliximab-dyyb and contains a suffix that does not identify the manufacturer directly or have any specific meaning. This is unlike the naming of the first-ever biosimilar, Sandoz' Zarxio, the biosimilar to Neupogen (filgrastim), which was named before the FDA draft guidance on biosimilar labeling was officially released and has a suffix that identifies the manufacturer (filgrastim-sndz). As it stands, the clinical trial information listed on the Inflectra label is almost exactly the same as the information on the Remicade label, even though the two products are not interchangeable-meaning the Inflectra label contains immunogenicity data pulled from the Remicade label.

Infliximab, commercialized by Hospira (now owned by Pfizer) under the trade name Inflectra, was approved in 2013 in parts of Europe and in 2015 in West Europe. Celltrion gained approval for infliximab under the name Remsima in 2012 in Korea.

Although Inflectra has been proven to be highly similar to Janssen Biotech's reference product, Jay Siegel, MD, chief biotechnology officer and head, scientific strategy and policy at Johnson & Johnson, adamantly stressed that infliximab-dyyb is not identical to Remicade. He wrote in a prepared emailed release, “It is important to note that the FDA has not approved Celltrion’s infliximab-dyyb as being interchangeable with Remicade. For FDA to determine a biosimilar is interchangeable with its reference product, a manufacturer must demonstrate that the biosimilar is expected to produce the same clinical result as the reference product in any given patient. In addition, the manufacturer must demonstrate the risk of alternating or switching between the reference product and biosimilar is no greater than the risk of using the reference product.”

Siegel also warned that J&J's subsidiary Janssen plans to protect its patents for Remicade, which he says remain enforceable until September 2018. He added, "A commercial launch of Celltrion’s infliximab-dyyb in advance of this date would be an infringement of our patents, and we intend to defend our intellectual property rights."

Source: FDA