- Samsung Bioepis said Tuesday the FDA will review its application to market a copy of the blockbuster anti-inflammatory drug Remicade (infliximab). This is the first attempt by the South Korean biosimilars company to break into the U.S. market.
- Samsung has received a positive recommendation for its biosimilar infliximab from the European Medicines Agency earlier this year, with a final decision from the European Commission pending.
- If approved, Samsung's copy would be only the third biosimilar approved in the U.S., following South Korean rival Celltrion's Inflectra and Novartis' Zarxio.
Samsung Bioepis is aggressively developing a wide array of biosimilar candidates, aiming to take advantage of expiring patents on a number of blockbuster biologic drugs, such as Humira, Avastin, Lantus, and others.
In addition to its Remicade copy, Samsung has also won E.U. approval for a biosimilar version of Pfizer's Enbrel.
But the company faces competition in the U.S., not least from its South Korean rival Celltrion. The FDA approved Celltrion's version of Remicade, marketed as Inflectra, in early April.
However, Johnson & Johnson, the producer of brand name Remicade, has said it will defend its intellectual property rights in the event Celltrion attempts to market Inflectra before September 2018, when the last of its patents expire.
If Samsung's copy is approved, marketing and distribution in the U.S. will be handled by Merck, under a 2013 commercialization agreement.
Samsung conducted Phase 1 and Phase 3 studies to test to equivalence of its biosimilar infliximab to branded Remicade, demonstrating comparable safety and efficacy.