Multiple biosimilars may have launched in a particular category, but this does not lessen the financial risk of a biosimilar manufacturer who has not settled (or cleared) their patent litigation. The recent filing by Genentech against Samsung Bioepis’ proposed Avastin® biosimilar, SB8, serves as a reminder.
The June 28th filing of Genentech v. Samsung Bioepis, which was reported by Big Molecule Watch. Genentech alleges that Samsung Bioepis is violating 14 different patents and failed to follow notification protocols as mandated in the BPCIA legislation, which established the biosimilar approval pathway.
Genentech had filed suit against Amgen (makers of Mvasi®) in October 2017, and although this litigation is unresolved, Amgen launched the biosimilar last summer. Genentech had also filed suit against Pfizer (makers of Zirabev®), but the parties reached a settlement September 19, 2019, clearing the way for a Pfizer launch in January 2020.
These patent litigations, including the newest involving Samsung Bioepis’ bevacizumab biosimilar, are not very interesting, except that there are at least seven biosimilars in development for this drug category. Samsung’s 351(k) application was accepted by the Food and Drug Administration in November 2019, with a decision expected in Q4 2020. However, partners Mylan and Biocon have also filed an application for their own Avastin biosimilar (MYL-1402O) just a month later.
No doubt, Genentech is committed to defending its intellectual property. Yet, does it intend to file suit against each developer, especially as its Avastin US marketshare drops precipitously (35% loss in marketshare since Mvasi’s introduction less than a year ago)? It seems apparent that Genentech is fighting a losing battle against a tide of manufacturers, and perhaps seeks little more than royalties or licensing fees from the upcoming challengers. This seems to be the case with Abbvie in its settlements with biosimilar producers of adalimumab. We’ll know more if Genentech announces a new suit against Mylan or Biocon involving MYL-1402O, which may also launch in the fourth quarter of this year if approved.
Don’t expect safety in numbers, in any case. Amgen still faces significant uncertainty with its at-risk launch last year. A jury trial is supposed to begin in November 2020. If the jury rules in Genentech’s favor, the profits from Mvasi in addition to punitive damages could be awarded by the judge.