Pfizer weighs 'strategic options' for newly FDA-approved Remicade biosim, its second

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Pfizer won FDA approval Wednesday for Ixifi, its second biosimilar to Johnson & Johnson's Remicade. Its first, Inflectra, is struggling to capture sales.

Pfizer is already working to pick up market share with Inflectra, the first biosimilar to Johnson & Johnson's blockbuster immunology med Remicade, but now the company has a second copycat boasting an FDA approval. 

But even now that the new med, Ixifi has the FDA's backing, Pfizer has no plans to launch the biosim in the U.S., according to a spokesperson. The drugmaker is "evaluating our strategic options for this medicine" instead, he said. 

How does a company win approval for a drug it doesn't plan to sell? When Pfizer bought Hospira back in 2015, the drugmaker already had one Remicade biosim in the works; Hospira brought along a second, which is now approved as Inflectra. On Wednesday, the FDA blessed Pfizer's internally developed candidate, formerly known as PF-06438179. 

RELATED: As J&J holds off U.S. biosims, Remicade's European market share falls to 50%

With that approval in hand, Pfizer could sell Ixifi or license it out. It's true that would create a new competitor for its own Inflectra. But there's precedent; the company sold off European rights to Novartis' Sandoz unit in a deal early last year, despite the fact that Inflectra's for sale in the EU as well. Since then, Sandoz has applied for marketing approval in Europe, and the EMA accepted its application in May. 

Then again, the U.S. biosimilar market has proven more difficult to crack for Inflectra than Europe was. It was one of the first biosims to hit the U.S. market—and the first Remicade copycat—but more than a year after its debut, the product is still sputtering commercially. The drugmaker launched at a 15% discount initially, then discounted Inflectra further after Merck launched the second Remicade biosim in July. Partnered with Samsung, Merck launched at a 35% discount. 

So far this year, Remicade has reeled in $3.45 billion in sales in the U.S., compared to $74 million for Pfizer's Inflectra. Merck didn't disclose Renflexis sales in its third-quarter results. 

Despite growing competition from biosims, J&J executives have stated that the company's stalwart med remains in a good position. Last year, pharma group chairman Joaquin Duato said the market is already “extremely competitive” on price, and that J&J intends to develop “innovative contracts” to “utilize the full breadth” of its portfolio. 

Pfizer isn't a fan of that strategy, of course. In a lawsuit against J&J, the company argued the tough contracting is "anticompetitive" and won't change unless a court intervenes. According to Pfizer, J&J tied discounts on the existing Remicade patient pool to the stipulation that payers don't use biosims, effectively shutting out the competition. 

J&J countered in a public statement that Pfizer isn't offering enough value to win business.