Janssen Biotech Inc. has succeeded in pushing back the earliest launch date for Pfizer Inc.'s biosimilar to Remicade (infliximab), though it may still come sooner than Janssen wishes.

Celltrion Inc. and US marketing partner Pfizer previously agreed not to launch Inflectra (infliximab-dyyb) in the US before June 30, the day after a patent covering a method of using infliximab to treat Crohn's disease expires ([A#00160411006]).

They now have agreed instead not to start marketing the biosimilar before Sept. 15 barring certain circumstances. The companies stipulated to the date in a June 6 filing in the US District Court for the District of Massachusetts as part of ongoing litigation with Janssen. FDA approved Inflectra April 5.

It is unclear why Pfizer and Celltrion chose Sept. 15 as the earliest possible launch date. Pfizer said it could not say anything more than what was in the court filing, which did not note the significance of the date. A Janssen spokesperson said that Remicade patents remain valid and enforceable until at least September 2018 and commercial launch of Celltrion's biosimilar prior to this date would be an infringement of its patents.

Janssen had filed a motion for a preliminary injunction to prevent marketing of the biosimilar until Oct. 2, 180 days after FDA approval of the product. It withdrew the motion pending a decision by the US Court of Appeals for the Federal Circuit in Amgen Inc. v. Apotex Inc. That case is addressing whether 180-day launch notification, required under the Biologics Price Competition and Innovation Act, can be given prior to FDA approval if the sponsor provides its application to the innovator company. The court heard oral arguments in the case on April 4.

In previous court filings Janssen said it would renew its preliminary injunction motion if the Federal Circuit did not issue a ruling before June 30, or the court's decision did not resolve the dispute ([A#14160510002]).

According to the June 6 court filing, the Inflectra launch could come before Sept. 15 if the parties agree that the Federal Circuit's forthcoming decision moots Janssen's renewed preliminary injunction motion to delay marketing until Oct. 2; the court denies Janssen's renewed motion; or Celltrion and Pfizer obtain a court order authorizing an earlier launch date.

Inflectra Partners Seek Patent Invalidity Ruling

Janssen's suit against Celltrion and Pfizer claims infringement of patent No. 6,284,471, which covers the infliximab antibody and expires in September 2018, and No. 7,598,083, which covers a particular cell media culture and expires in February 2027.

The Patent and Trademark Office found the '471 patent to be invalid in a reexamination proceeding and the decision is on appeal to the PTO's Patent Trial and Appeal Board. Celltrion and Pfizer have asked the court to enter summary judgment of invalidity of the patent for obviousness-type double patenting.

In a May 31 briefing schedule, Massachusetts District Judge Mark Wolf said that if the Federal Circuit does not issue a ruling in Amgen v. Apotex by June 29, the parties are to meet and "discuss how to proceed fairly and efficiently" and provide the court with a joint status update by July 6. A hearing on motions in the case is to begin Aug. 16.

Inflectra is the second biosimilar to clear FDA, following the approval of Sandoz Inc.'s Zarxio (filgrastim-sndz), a biosimilar to Amgen's Neupogen (filgrastim). In May, Samsung Bioepis Co. Ltd., a South Korean-based joint venture of Samsung BioLogics and Biogen Inc., announced that FDA had accepted an application for its biosimilar to Remicade. The application was submitted in March and is undergoing a 10-month review, which would put the user fee goal date in January 2017. If approved the product would be commercialized by Merck & Co. Inc. ([A#14160524001]).

Pfizer's Remicade Biosimilar: Sept. 15 Is Earliest Launch Date

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