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.

For more information on these and other biosimilars, please visit BiologicsHQ.



The authors would like to thank April Breyer Menon for her contributions to this article.


    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website ( Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.


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