FDA set to approve Remicade biosimilar
pharmafile | February 9, 2016 | News story | Manufacturing and Production, Research and Development, Sales and Marketing | Remicade, biosimilars, remsima
An FDA committee has had some positive words for Celltrion’s biosimilar candidate to Janssen/MSD’s Remicade (infliximab), concluding that the copycat biologic drug is “highly similar” to the reference product, in a briefing document released ahead of a hearing to be held later today.
At a recent meeting, the FDA’s Arthritis Advisory Committee discussed Celltrion’s biologics license application (BLA), which seeks approval for CT-P13 in all of Remicade’s approved indications, namely Chron’s disease, Paediatric CD, Ulcerative Colitis (UC), Paediatric UC, Ankylosing Spondylitis, Psoriatic Arthritis and Plaque Psoriasis.
Celltrion can take heart from the Committee’s report, which says “Celltrion’s data support the demonstration of ‘no clinically meaningful differences’ between CT-P13 and the US Remicade in terms of safety, purity, and potency in the indications studied.”
However, the news will worry Janssen, as the positive opinion means Remicade, which earnt it $4.5 billion in revenues in last year, may well face cheaper competition in its most important market sooner rather than later. Remicade is marketed by Janssen-J&Js’ pharma division- in the US, while MSD holds the rights for Europe, Russia and Turkey.
South Korea-based Celltrion’s biosimilar is already approved in Europe as Remsima, and has been sold by the South Korean company’s partner Hospira since early 2015. Remsima sales have already hit those of the original Remicade in European markets, and it now appears Celltrion’s version is on course to become the second biosimilar to be approved in the US, following Novartis’ Zarxio last year.
The FDA Committee’s report reads: “The results of the clinical development program indicate that Celltrion’s data support the demonstration of “no clinically meaningful differences” between CT-P13 and the US Remicade in terms of safety, purity, and potency in the indications studied.”
It also noted that the transition in the EU from Remicade to the biosimilar did not result in worse safety or immunogenicity profiles, as well as the extensive data package provided by Celltrion in support of the biosimilar.
Joel Levy
Related Content
Samsung Bioepis & Biogen receive positive CHMP opinion for ranibizumab biosimilar
Samsung Bioepis and Biogen have announced that the EMA’s Committee for Medicinal Products for Human …
Biosimilars and Brexit: What’s in store for UK’s biosimilar market?
It’s been 15 years since the first biosimilar entered the market, and the impact of …
Celltrion’s infliximab biosimilar Remsima secures European approval in five indications
The subcutaneous (SC) formulation of Remsima, Celltrion’s biosimilar version of infliximab, has secured approval from …