Biosimilar Launch and Approval Updates – Tyenne® (tocilizumab-aazg), Xlucane™ (ranibizumab), Hercessi™ (trastuzumab-strf) | Venable LLP
First Actemra® Biosimilar Launch – Fresenius Kabi’s Tyenne® (tocilizumab-aazg)
On April 15, 2024, Fresenius Kabi announced the U.S. launch of Tyenne® (tocilizumab-aazg), the first Actemra® (tocilizumab) biosimilar to launch in the U.S., after receiving FDA approval in March 2024 (see Fresenius Kabi’s Actemra® biosimilar Tyenne® (tocilizumab-aazg) Approved in the U.S.). Tyenne® was the first Actemra® biosimilar to be approved with both IV and SC formulations.
Tyenne® was launched pursuant to a confidential settlement agreement, entered into after Fresenius filed seven IPRs against various patents owned by Chugai Seiyaku Kabushiki Kaisha, Hoffmann-La Roche, and Genentech covering methods of treatment and drug delivery devices.
Biogen and Bio-Thera’s Tofidence™ (tocilizumab-bavi) was approved in September 2023, but has yet to launch, following the settlement of a BPCIA lawsuit (1:23-cv-11573 (D. Mass.)) in October 2023, with an undisclosed launch date (see BPCIA Litigation Related to Actemra® Biosimilar Tofidence™ Settles).
Celltrion’s pending aBLA for its proposed Actemra® biosimilar CT-P47 was accepted by the FDA in January 2024. Celltrion recently prevailed in two IPR challenges against U.S. Patent Nos. 8,580,264 (IPR2022-00578) and 10,874,677 (IPR2022-00579) owned by Chugai, Genentech, and Hoffmann-La Roche (see Chugai, Genentech, and Hoffmann-La Roche Dismiss Appeals of Actemra® Patent IPR Final Written Decisions). These were the last pending patent disputes related to Actemra® biosimilars.
Roche reported worldwide sales of Actemra® in 2023 were approximately $3 billion USD.
Xbrane’s Xlucane™ (ranibizumab) Receives Complete Response Letter
On April 21, 2024, Xbrane provided an update on the FDA review of Xlucane™ (ranibizumab), its proposed biosimilar of Genentech’s Lucentis® (ranibizumab), after resubmitting its aBLA in April 2023. Xbrane announced the receipt of a Complete Response Letter from the FDA, which according to its press release “relate[d] primarily to the reference standard and pre-approval inspections of manufacturing partners’ sites.” Xbrane clarified that the FDA had not requested re-inspections of any sites or any further studies to demonstrate biosimilarity. Xbrane indicated it will announce a date for resubmission of its aBLA following discussions with the FDA.
Two interchangeable biosimilars of Lucentis® have already been approved and launched, Samsung Bioepis’s Byooviz™ (ranibizumab-nuna) and Coherus’s Cimerli™ (ranibizumab-eqrn).
Currently there are no pending biosimilar patent disputes related to Lucentis® biosimilars.
Novartis and Roche reported 2023 Lucentis® sales of approximately $1.475 billion USD.
New Herceptin® Biosimilar Approval – Accord BioPharma’s Hercessi™ (trastuzumab-strf)
On April 29, 2024, Accord BioPharma and Shanghai Henlius Biotech announced the FDA approval of Hercessi™ (trastuzumab-strf), a biosimilar of Genentech’s Herceptin® (trastuzumab). Hercessi™ is the sixth biosimilar of Herceptin® to be approved in the U.S. and is Accord’s first U.S. biosimilar approval. Accord has a number of other pending aBLAs, including for Accofil® (filgrastim) (proposed Neupogen® biosimilar), Pelgraz™ (pegfilgrastim) (proposed Neulasta® biosimilar), and DMB-3115 (ustekinumab) (proposed Stelara® biosimilar).
Currently there are no pending biosimilar patent disputes related to Herceptin® biosimilars.
Roche reported 2023 Herceptin® sales of approximately $1.77 billion USD.
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The authors would like to thank April Breyer Menon for her contributions to this article.
