Can Celltrion's Remicade biosim repeat its EU market-share steal in the U.S.?

The first Remicade biosimilar has won approval in the U.S.--and now it's time to see if it'll cause the same pain for Johnson & Johnson ($JNJ) that it has for Merck ($MRK) overseas.

Late Tuesday, the FDA green-lighted the Celltrion and Hospira med, dubbed Inflectra, as a treatment for Crohn's, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis, making it just the second biosimilar to get the go-ahead from the agency. And as Kim Hyoung-Ki, CEO of South Korea's Celltrion, told Reuters Wednesday, he expects the product will hit the market at about 20% to 30% below Remicade's price--though his company still has to work out a final cost with Hospira's new owner, Pfizer ($PFE).

There's plenty of potential in the U.S. for the newcomer, with Remicade racking up $4.5 billion in U.S. sales last year. But stateside marketer Johnson & Johnson has insisted the downfall of its blockbuster isn't imminent.

Biosimilars "are not generics," CEO Alex Gorsky told investors on the company's Q4 conference call, noting that 70% of its Remicade patients "have a pretty high satisfaction rate" and are unlikely to jump ship.

But if the FDA gets its way, biosimilars will bear pretty similar labels to generics; last week, it rolled out draft guidance recommending that data proving a drug's biosimilarity--which reference product-makers favor as a tool for setting their meds apart from their copies--not make the label.

And meanwhile, the Remicade knockoff is tearing it up in Europe, where the original brand is sold by Merck. In Q4, Merck's quarterly sales of the drug sunk 29% to $396 million--an 18% decline at constant exchange rates.

Pfizer, for one, certainly wouldn't mind a similar performance for Inflectra in the U.S. On Wednesday, it called off its $160 billion Allergan ($AGN) merger in the wake of a U.S. tax crackdown.

- read the release
- see Reuters' take

Special Reports: The 10 best-selling drugs of 2013 - Remicade | Top 20 generics companies by 2014 revenue - Hospira