As we previously reported, in July 2023 Genentech, Inc., Hoffmann-LaRoche, Inc., and Chugai Pharmaceutical Co., Ltd. (collectively, “Genentech”) filed BPCIA litigation against Biogen MA Inc. and Bio-Thera Solutions, Ltd. in the District of Massachusetts, asserting that Biogen sought FDA approval “to commercialize ‘BIIB800,’ a proposed biosimilar to Genentech’s drug Actemra® (tocilizumab).” On October 23, the parties filed a Joint Stipulation of Dismissal with the Court, stating that they “have entered into a settlement agreement, and mutually agree to voluntarily dismiss all claims asserted in the above-captioned case with prejudice.” The parties further agreed to bear their respective attorney fees and waive all rights to an appeal.
On September 29, Biogen received FDA approval for its tocilizumab biosimilar, marketed as TOFIDENCE (tocilizumab-bavi). TOFIDENCE is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. To date, TOFIDENCE is the only FDA-approved tocilizumab biosimilar of Genentech’s ACTEMRA.