- The Food and Drug Administration on Friday approved Renflexis (infliximab-abda), Samsung Bioepis and Merck & Co's biosimilar form of Johnson & Johnson's Remicade.
- This is the first U.S. approval for Samsung Bioepis and the second Remicade biosimilar approved for use in the U.S. market, where it will be sold by Merck & Co. Pfizer and its partner Celltrion began shipping their Remicade biosimilar, Inflectra (infliximab-dyyb), at the end of October.
- The FDA approval for Renflexis, a tumor necrosis factor (TNF) blocker, covers all of Remicade's indications: adult and pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
While Renflexis is the fifth biosimilar approved in the U.S., only two of the copycat biologics (Pfizer's Inflectra and Novartis' Zarxio) have so far been introduced to market due to ongoing litigation proceedings.
Although the entry of generic drugs has historically spelled doom for the reference product, biosimilars are not likely to play the same role in the marketplace, at least at first. For example, Pfizer priced Inflectra only 15% lower than Remicade, a far cry from the steep discounts typically seen in the generic space. Biosimilar drugmakers also face an uphill battle in educating physicians and the public about what exactly biosimilars are and the role they can play in treatment.
Due to these challenges, Remicade sales have not been substantially eroded by biosimilar competition just yet. Last week, Johnson & Johnson reported only a 6% drop in sales for the originator drug, which company CFO Dominic Caruso suggested was due to a reluctance by physicians to switch from the branded form to the biosimilar.
Caruso predicted a slow shift from Remicade, rather than the much faster fall in sales often seen with small molecule generics. Pfizer and Celltrion aren't giving up, though. They are currently pushing for claims of interchangeability, which would allow pharmacists to substitute Inflectra for Remicade without a physician's ok.
Samsung Bioepis is a joint venture between Korean contract manufacturing company Samsung BioLogics and U.S. biopharma Biogen Idec, and has a pipeline of biosimilars that are commercialized by Biogen Idec and Merck & Co
Samsung Bioepis gained approval of Renflexis in Korea back in 2015, and in Europe in 2016, and it is also approved in Norway, Liechtenstein, Iceland and Australia.