Recently, in Adello Biologics LLC v. Amgen Inc., Case PGR2019-00001 (Paper No. 13) (PTAB Apr. 19, 2019), the PTAB instituted post-grant review of claims 1-30 of U.S. Patent No. 9,856,287 (“the ’287 patent”).  The ’287 patent is the patent at issue in a pending litigation between Amgen and Apotex under the Biologics Price Competition

  • FDA approves the second Enbrel® (etanercept) biosimilar—no etanercept biosimilar has launched in the United States to date.
  • FDA approves the fourth Herceptin® (trastuzumab) biosimilar—no trastuzumab biosimilar has launched in the United States to date.
  • European Medicines Agency approves ninth and tenth adalimumab biosimilars and second bevacizumab biosimilar.

As pharmaceutical drug costs attract increasing media attention

  • Coherus launches UdenycaTM, a pegfilgrastim biosimilar, in the United States.
  • Pfizer launches Retacrit®, an epoetin alfa biosimilar, in the United States.
  • FDA approves the first rituximab biosimilar, although it has not yet launched in the United States.
  • European Medicines Agency approves third, fourth, and fifth pegfilgrastim biosimilars and a fifth trastuzumab biosimilar, while

  • European Medicines Agency approves first two pegfilgrastim biosimilars and another adalimumab biosimilar
  • Pfizer launches NivestymTM, a filgrastim biosimilar, in the United States
  • Only five of twelve approved biosimilars have launched in the United States

As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set

On March 8, 2018, Amgen Inc. (“Amgen”) filed suit against Adello Biologics, LLC (“Adello”) in the District of New Jersey, alleging infringement of seventeen patents:  U.S. Patent Nos. 6,180,391; 7,083,948; 7,118,884; 7,384,765; 7,427,659; 7,662,930; 7,735,525; 7,781,395; 8,191,566; 8,273,707; 8,940,878; 8,952,138; 9,418,416; 9,632,095; 9,643,997; 9,704,239; and 9,856,287.  The case is assigned to Judge Claire C. Cecchi

As we recently covered, May 15, 2018, saw the FDA granting approval to Hospira (now a Pfizer subsidiary) for its Retacrit injection, a biosimilar to Amgen’s Epogen®. The approval, based on a Biologics License Application dated December 16, 2014, came after Hospira resubmitted its application twice after receiving Complete Response Letters from the FDA,

Since our prior article on the litigation between Amgen and Hospira over Hospira’s proposed biosimilar to Amgen’s Epogen®, there have been several developments, including those that occurred after the Supreme Court’s recent Amgen v. Sandoz decision.

The last major development we previously discussed was a motion for a preliminary injunction filed by Amgen seeking “to