] Samsung Bioepis is expected to receive a milestone payment of some 20 billion won (US$17.63 million) from its collaboration with Merck, following US regulatory approval to sell its biosimilar of Johnson & Johnson‘s Remicade, according to a news report on May 10.
As part of a research collaboration and license agreement between Samsung Bioepis and Merck, the US pharma giant is required to make payments to the Korean firm based on reaching regulatory milestones.
On April 22, Bioepis got a nod from the US Food and Drug Administration to sell Renflexis in the local market, which will be marketed and distributed by Merck.
Bioepis is likely to receive the payment in May and will reflect the amount in the company’s second quarter earnings.
The Korean company expects Merck to start selling its biosimilar of blockbuster rheumatoid-arthritis treatment Remicade in October and compete against another biosimilar from Celltrion and Pfizer called Inflectra.
“The sales of Celltrion’s Remicade biosimilar in the US are accelerating, but the market itself is so large that Renflexis could soon generate multibillion won sales,” an industry watcher said.
Having a pipeline of six biosimilar candidates, Bioepis could secure additional milestone payments from global retail partners if it clears regulatory hurdles later this year.
Last year, it filed for approval of its copy of Roche’s blockbuster breast cancer drug Herceptin and AbbVie rheumatoid arthritis drug Humira, both in Europe. Biogen holds exclusive marketing licenses for the two drugs.
The Suwon-based company logged 148.3 billion won in revenue from biosimilar-related business, mainly from two drugs -- Benepali and Renflexis -- including sales and milestone payments.
By Park Han-na (firstname.lastname@example.org)