The FDA has approved Celltrion and Pfizer’s biosmiliar of Johnson & Johnson's Remicade (infliximab) for treating Crohn's disease, ulcerative colitis, rheumatoid arthritis, psoriasis and arthritis of the spine – making it only the second biosimilar approved in the US.
HyoungKi Kim, CEO of Celltrion, said that the company’s biosimilar, named Inflectra, is expected to be priced 20 to 30 percent lower than Remicade in the US market.
Remicade has generated annual worldwide sales of $6.5 billion, of which $4.5 billion were in the United States. In the UK, the approval of biosimilar infliximab last year led to a sharp decline in sales of the original drug.
The first biosimilar launched in the US, Sandoz’s copycat of Amgen’s Neupogen, faced a rocky road on the way to approval, with Amgen attempting to delay its sale until a patent dispute between the firms was settled.
HyoungKi said that Celltrion hopes the process will become smoother for all companies in the future: “As one of the first companies to navigate the biosimilar approval pathway with the FDA, we believe this approval will be an essential step in helping to clarify the application process for these critical medicines.”
“Our experience with biosimilars outside the US suggests that Inflectra provides patients with both therapeutic and financial benefits, and we hope to see the same value provided in the US.”