Remicade's U.S. patent rejection could open up early rivalry with Celltrion biosim

The U.S. Patent Office gives, and the U.S. Patent Office takes away.

Unfortunately for Johnson & Johnson ($JNJ), it was the latter for Remicade. After a re-examination of Remicade's September 2018 patent, agency officials issued a big fat rejection.

If it sticks, the patent rejection could open the blockbuster anti-inflammatory drug to biosimilar competition as early as next year. South Korea's Celltrion has been working toward just such a situation, with its Remicade biosim under FDA review even as we speak. The drug will have its moment with an FDA advisory panel next month; partner Hospira ($HSP) sells it in Europe under the Inflectra brand, and Celltrion sells it in dozens of countries as Remsima.

The unexpected competition could take a bite out of Remicade's $8 billion-plus in sales, though how much of a bite is open to question. Doctors would have to prescribe Celltrion's version by name, because there's no automatic substitution on the biosimilar side as there is in the small-molecule generics business.

If Europe's experience is any guide, the uptake could be slow. Biosimilars have been available in European countries for some time--in some markets longer than others, of course--and so far haven't sold very well. Doctors are wary--to the point where Norway is funding a head-to-head trial, pitting Inflectra against the Remicade brand, in an effort to show physicians that biosims are viable alternatives.

And J&J may end up keeping its exclusivity through September 2018, when the patent at issue--the '471 patent--expires. "We have 60 days to respond to this action and will do so," the company said in a terse statement announcing the PTO decision. "We believe the '471 patent is valid and, if necessary, will pursue all available appeals."

- read the J&J statement

Special Reports: The best-selling drugs of 2013 - Remicade

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