2021 Biosimilar Approval and Litigation Update
The last two years saw the launch of several biosimilars. Looking ahead to 2021, several others may be on the horizon. In 2019-2020, the FDA approved thirteen biosimilars directed to seven reference products. Eight of the approved biosimilars have launched, while five are either embroiled in litigation or awaiting agreed-upon launch dates. Over the last two years, biosimilars launched for:
- Avastin® (bevacizumab): Zirabev®, January 2020
- Herceptin® (trastuzumab): Kanjinti™, July 2019; Trazimera™, February 2020; Ontruzant®, April 2020
- Neulasta® (pegfilgrastim): Ziextenzo®, November 2019
- Remicade® (infliximab): Avsola™, July 2020
- Rituxan® (rituximab): Ruxience®, January 2020; Riabni™ (expected January 2021)
Three biosimilars to Humira® (adalimumab)—Hadlima™, Abrilada™, and Hulio®—were approved by the FDA but will not launch until 2023 as a result of agreements between their manufacturers and AbbVie. Likewise, Eticovo™ (an Enbrel® (etanercept) biosimilar) and Nyvepria™ (a Neulasta biosimilar) have been approved but have been involved in litigation and have not launched.
Following Eticovo’s April 2019 approval, Immunex, Amgen, and Hoffman-La Roche filed suit in the District of New Jersey seeking to enjoin its launch. See Immunex Corp. v. Samsung Bioepis Co., Ltd., No. 2:19-cv-11755 (D.N.J.). The parties entered a confidential stipulation in December 2019, after which the Court entered a consent injunction preventing Samsung from launching Eticovo in the United States. Dkt. 113. The Court then stayed the litigation (Dkt. 116) and Eticovo’s future launch date remains unknown.
Nyvepria has also been the subject of litigation. In February 2020, Amgen filed suit in the District of Delaware seeking to prevent its launch. See Amgen Inc. v. Hospira, Inc., No. 1:20-cv-00201 (D. Del.). In March 2020, Hospira filed a motion to dismiss, which is still pending. See Dkt. 12, 19. Nyvepria was subsequently approved by the FDA in June 2020. The parties are engaged in claim construction and trial is scheduled to start in July 2022.
Last year also saw litigation involving a biosimilar that is yet to be approved by the FDA. In June 2020, Genentech sued Samsung Bioepis seeking to prevent the launch of Samsung’s Avastin (bevacizumab) biosimilar. See Genentech, Inc. v. Samsung Bioepis Co. Ltd., No. 1:20-cv-00859 (D. Del.). Genentech’s motion to dismiss Samsung’s counterclaims remains pending. See Dkt. 12. The case is scheduled for trial starting in July 2023.
The year ahead may offer clarity as to the projected launch dates for these pending biosimilars.