Merck & Co., Samsung Bioepis introduce Remicade biosimilar Renflexis in US

Merck & Co. and Samsung Bioepis on Monday announced the US launch of Renflexis (infliximab-abda), a biosimilar referencing Remicade (infliximab). Renflexis will be marketed by Merck in the US, where it was approved in April across all eligible indications, as part of a global biosimilars development and commercialisation agreement reached in 2013 with Samsung Bioepis. 

Meanwhile, Merck also sells Remicade in certain countries outside the US, including in Europe, while partner Johnson & Johnson markets the drug in the US. Johnson & Johnson recently disclosed that revenue from Remicade fell 14 percent in the second quarter to $1.5 billion, while the drug's US sales totalled $4.8 billion last year.  

Merck and Samsung Bioepis noted that Renflexis will carry a wholesale list price of about $753, reflecting a 35-percent discount to the current list price for Remicade. Dora Bibila, general manager at Merck Biosimilars, said the company "believes that biosimilars have the potential to help increase access to these important medicines, while also providing savings for the healthcare system." 

Renflexis is the second Remicade biosimilar available in the US following Pfizer and Celltrion's Inflectra (infliximab-dyyb), which was cleared by the FDA in April 2016. Pfizer, which markets Inflectra in the country, gained rights to the biosimilar via its acquisition of Hospira. Inflectra is priced 15 percent below the current price for Remicade, whose annual cost is more than $30 000 on average for adults.

Nevertheless, Johnson & Johnson CEO Alex Gorsky recently said "physicians have a strong preference for Remicade versus biosimilars and we enjoy a strong access position in the US," adding that "we'll continue to compete in the market and defend our [intellectual property] against biosimilars to launch at risk in the US." In May, Johnson & Johnson filed a patent infringement lawsuit in US district court seeking to block the launch of Renflexis in the country. A hearing for the lawsuit has yet to be scheduled.

Meanwhile, Merck was recently accused by the UK's Competition and Markets Authority (CMA) of having breached UK and EU competition law by implementing a discount scheme in relation to the supply of Remicade to the NHS. According to the CMA, the alleged scheme for Remicade "was likely to restrict competition from biosimilar versions of [the product] that were new to the market." Samsung Bioepis introduced a biosimilar version of Remicade in the UK last year under the name Flixabi, formerly known as SB2.