FDA approves a Fourth Biosimilar of HERCEPTIN

Yesterday, the U.S. FDA approved Pfizer’s Trazimera™ (trastuzumab-qyyp), a biosimilar of Genentech’s Herceptin®, for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.  These indications are the same as those for which the reference product is approved.

Trazimera™ is the fourth trastuzumab biosimilar, and the eighteenth biosimilar overall, to receive FDA approval.  Its approval follows the FDA’s licensure of Mylan’s Ogivri™ (trastuzumab-dkst) in December 2017, Celltrion’s Herzuma™ (trastuzumab-pkrb) in December 2018, and Samsung Bioepis’s Ontruzant™ (trastuzumab-dttb) in January 2019.  Indeed, the last three biosimilars to gain FDA approval have all been trastuzumab biosimilars.  To date, no trastuzumab biosimilars have launched in the United States.

As we previously reported, Pfizer, Mylan, and Celltrion settled their patent disputes with Genentech.  Amgen, whose trastuzumab biosimilar is not yet approved, and Samsung Bioepis remain engaged in BPCIA patent litigations against Genentech regarding their respective trastuzumab biosimilars.