Most Americans know Samsung as the maker of the Galaxy Smartphone, but now the South Korean mega-conglomerate wants to nab a healthy slice of the U.S. Drug market.
Samsung’s Bioepis arm has been on a quest to create biosimilars—or copycats of biologic drugs that are usually priced at deep discounts—of some of the world’s top therapies. And on Monday, the company said the FDA will review the application for its biosimilar of Johnson & Johnson’s Remicade, an anti-inflammatory arthritis medication that is among the top five highest-selling drugs in the world whose sales totaled more than $6.5 billion last year.
Samsung Bioepis has had several of its biosimilars approved in European and Asian markets, but its Remicade copycat application is its first foray into the U.S.
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Biosimilars are a fledgling market in America despite their popularity in many other countries. The FDA is still finalizing regulatory decisions about the products and only approved the first U.S. Biosimilar last year, Novartis’ (NVS) copy of Amgen’s (AMGN) Neupogen, called Zarxio.
The agency also approved a different Remicade biosimilar just last month from South Korea’s Celltrion and its U.S. Partner, Pfizer (PFE). The companies are reportedly mulling a 20% to 30% discount for the therapy, Inflectra, over its branded counterpart.
Biosimilars’ burgeoning popularity has fostered some intriguing partnerships as companies try to create new, innovative biologic therapies, defend their existing products from sales slumps, and develop biosimilars to eat into competitors’ branded biologics sales.
For instance, Samsung Bioepis is allied with U.S. Firms Biogen (BIIB) and Merck (MRK). The latter firm will be responsible for marketing and distributing the Remicade biosimilar in America if it wins the FDA’s blessing. But under an arrangement with Johnson & Johnson, Merck also owns marketing rights to the original branded Remicade in Russia, Turkey, and Europe, where the company has itself been feeling a sales pinch thanks to competition from heavily discounted biosimilars of the therapy.