Pfizer cautious on Remicade biosimilar U.S. launch after J&J blast

Pfizer HQ
Pfizer headquarters

Pfizer ($PFE) is ready to go at the end of June with a biosimilar of Remicade in the U.S., executives said on the May 3 earnings call, sidestepping a direct counter claim to remarks from Johnson & Johnson ($JNJ) that there is no threat of that action this year to the product from its Janssen Biotech unit shared with Merck ($MRK).

Pfizer owns the rights to the copycat biologic by virtue of its purchase of Hospira last year--which in turn has a marketing pact with South Korea's Celltrion. The biosimilar dubbed Inflectra (infliximab-dyyb), has been sold in Europe since 2015.

The FDA noted at the time of approval it was the second biosimilar approved after Novartis' ($NVS) Sandoz unit won last year for Zarxio, a biosimilar of Amgen's ($AMGN) Neupogen (filgrastim).

Ian Read, chairman and CEO, was a bit cautious on the exact launch date--which served to only heighten analysts' interest after Johnson & Johnson's CFO Dominic Caruso was emphatic on the April 19 earnings call that a biosimilar of Remicade will not be launched in the U.S. this year.

"While launch timing of Inflectra will ultimately depend upon a number of factors, such as marketplace dynamics and intellectual property considerations, we are continuing with the preparation of our launch plans for 2016," Read said on the call, adding the company holds exclusive commercialization rights to this product in the U.S.

However, John Young, president of Pfizer's established pharma unit, gave a bit more on the issue when asked by Deutsche Bank analysts Gregg Gilbert, on how the regulatory issues may play out on a biosimilar of Remicade.

"In regard to Inflectra, launch timing will ultimately depend on a number of factors including marketplace conditions, payer dynamics, expected timing for entry of other products, and intellectual property-related considerations among others," he said.

"Pursuant to the stipulation entered in recent core conference related to ongoing litigation between Hospira, Celltrion, and Janssen, Hospira agreed not to sell Inflectra in the U.S. prior to June 29, 2016, with the expiration of the its Crohn's patent. We are moving ahead with the preparation of our launch plans for 2016 as you heard in Ian's [Read] comments, and we can't comment further beyond those points."

Young later noted that the biosimilar portfolio of Pfizer, legacy Pfizer, and legacy Hospira asset has "around nine distinct biosimilar molecules in different stages of development and approval. We are going to look to optimize the launch of that portfolio on a global basis over the coming years."

Separately, Read took time to note that Pfizer, through the Hospira purchase, is now the world's top sterile injectables company.

"We now have one of the broadest and most diverse offerings of difficult to manufacture sterile injectable medicines, which are critically important for patients around the world," Read said.

"This leading market position combined with our expanded biosimilars offering and the continued growth of Pfizer's legacy branded portfolio in emerging markets, will help us to move the established pharmaceuticals business from a period of loss of exclusivity driven decline to potential growth. The Hospira acquisition was a clear growth driver, and the integration continues to proceed well."

- here's the Pfizer earnings release

Read more on