J&J updates on Celltrion Remicade biosimilar in U.S. outlook with October date

Wall Street

Johnson & Johnson ($JNJ) executives were emphatic in April that there would be no U.S. launch for a biosimilar of Remicade (infliximab) in 2016. But in the second quarter earnings call this week, the company gave some wiggle room on that forecast.

Incheon-based Celltrion had hoped to launch its intravenously administered rheumatoid arthritis biosimilar Inflectra (infliximab-dyyb) as early as the end of June, with sales being handled by Pfizer ($PFE) by dint of a marketing pact it now holds after the acquisition of Hospira.

That date was challenged by Johnson & Johnson successfully under 180-day provisions. The company’s chief financial officer, Dominic Caruso, noted other litigation related to the patent, as well as a hearing scheduled next month that may provide clarity.

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But Caruso told analysts on the July 19 earnings call that the current state of play means the earliest date for any biosimilar launch is a few months away.

"There was also a ruling issued in relation to another biosimilar, not our biosimilar, which made it very clear when the 180-day waiting period applies," Caruso said. "And for us, that 180-day waiting period extends through October 6, so obviously there cannot be any launch before that date."

Caruso added that in any event, legal moves to block a launch in the near-term remain the strategy.

"And then as we have mentioned, we're continuously and vigorously defending our patent, and will continue to do that. So whether or not a biosimilar launch happens is uncertain, but we have not included it in our guidance estimates. But as you know, our guidance, of course, is a range, between certain ranges of 3% to 4% in overall growth, so we feel confident about that, in any event."

Separately on the call, Louise Mehrotra, the outgoing vice president of Investor Relations, put some figures on Asia-Pacific/Africa for the company with overall growth of 2.1% across divisions. Mehrotra repeated that the impact of hyper-inflation in Venezuela hit overall operational growth for the company outside the U.S. by 90 basis points.

And CEO Alex Gorsky briefly mentioned a renewed push to get better growth rates and earnings in China.

- here's the release

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