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.
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