In April, the US Food and Drug Administration (FDA) recommended the approval of Renflexis, a biosimilar version of Johnson & Johnson’s autoimmune biologic Remicade (infliximab) developed by Samsung Bioepis.
And yesterday the Korean drugmaker’s US commercialisation partner Merck & Co. – known as MSD outside North America – announced the launch of Renflexis (infliximab-abda) for injection to treat the same indications as Remicade.
The product becomes the second version of Remicade to become available in the US after Pfizer launched Inflectra (infliximab-dyyb), developed by Korean drugmaker Celltrion, late last year.
Inflectra entered the market at a 15% discount to the wholesaler acquisition cost of the reference product, but Merck is looking to undercut this by introducing Renflexis at $753.39, a discount of 35% on the list price of Remicade.
"With respect to commercialisation, while Merck is not commenting specifically on details of its commercial strategy for Renflexis in the US, each market and molecule is different and we will deploy different strategies based on the specific needs of each market," spokesman Robert Consalvo told Biopharma-Reporter.
"Merck believes that biosimilars have the potential to help increase access to important medicines that patients need, while also providing savings for the healthcare system, and that our pricing of Renflexis in the US is an example of how we are working to help ensure medicines and vaccines are affordable."
Renflexis is the third biosimilar to be launched in the US, following Sandoz’s version of Amgen’s Neupogen (filgrastim), Zarxio, in September 2015 and Inflectra. A Sandoz version of Amgen’s Enbrel (etanercept) and an Amgen version of AbbVie’s Humira (adalimumab) were approved in August and September 2016, but neither has yet been launched.
J&J confident to retain sales
J&J – which told investors last week it had seen only a 5% decline in Remicade sales since the introduction of Inflectra rather thean the forecasted 10-15% – said physicians' trust of Remicade would ensure it remained competitive.
"People living with autoimmune diseases who are taking biologics have often undergone and failed treatment with several other medicines, often for several years, before achieving control of their symptoms with their current therapy. We are therefore focused on making sure people who are currently stable on Remicade can stay on Remicade, and aren’t told they have to switch to a biosimilar," spokeswoman Caroline Parvis told us.
"We are also working to ensure physicians who want to prescribe REMICADE as the first choice have access to do so. In fact, Remicade has 96% first line biologic access for commercial patients. Of note, 74% of commercial medical lives are covered by plans that prefer Remicade."
Furthermore, she added similar to Inflectra, Merck’s biosimilar was not granted an interchangeable designation by the FDA. "There are no approved interchangeable biosimilars and to our knowledge, no studies have been conducted with the goal of demonstrating interchangeability with Remicade."
At the time of publication, Pfizer had not responded to a request for comment on the launch of Renflexis and its 35% discount rate.