The EMA issued a positive recommendation that both Celltrion's and Hospira's biosimilar versions of J&J's Remicade receive approval for use in the EU. If the EC follows the advice as expected, then both drugs will be the first biosimilar mAbs approved and J&J (and partner Merck) will potentially have more competition on its hands. Celltrion's drug will be called Remsima and Hopsira's will be sold under the name Inflectra.
I say potentially as J&J will have legal avenues that it can pursue to try to keep either competitor off the market. The blocking strategy would result from J&J's IP position with Remicade which has not run the course of its patent life just yet. If alternate forms of Remicade do make it to market, this will represent the first big blockbuster mAb that has competition from biosimilar producers. And we can expect more to come. Earlier this week, Sandoz indicated that it had 7 biosimilars in clinical trials and certainly most of these are current blockbuster mAbs reaching toward their patent expiration dates.
The movement toward biosimilars won't be stemmed in my view. The economic argument favoring them with governments and other third party payers is just too strong to ignore. Biosimilar versions of Remicade are projected to provide at least 30% savings in price. Said Kim Hyoung Ki, senior VP and CFO of Celltrion, "We're confident in Remsima as it has price competitiveness, while it has the same effect as the originator drugs." See Fierce Biotech.
Posted by Bruce Lehr June 28th 2013