Fresenius Kabi announced the U.S. launch of Tyenne® (tocilizumab-aazg) on April 15, 2024, marking the first biosimilar of Roche's Actemra® (tocilizumab) to reach the American market. The launch follows FDA approval in March 2024, making Tyenne® the first Actemra® biosimilar approved with both intravenous (IV) and subcutaneous (SC) formulations.
The launch proceeded under a confidential settlement agreement after Fresenius filed seven inter partes reviews (IPRs) against patents owned by Chugai Seiyaku Kabushiki Kaisha, Hoffmann-La Roche, and Genentech covering methods of treatment and drug delivery devices.
Competitive Landscape for Tocilizumab Biosimilars
While Tyenne® is the first to market, it faces future competition from other approved and pending tocilizumab biosimilars. Biogen and Bio-Thera's Tofidence™ (tocilizumab-bavi) received FDA approval in September 2023 but has yet to launch following a settlement of Biologics Price Competition and Innovation Act (BPCIA) litigation with an undisclosed launch date.
Celltrion's proposed Actemra® biosimilar CT-P47 is currently under FDA review, with its application accepted in January 2024. Celltrion recently prevailed in two IPR challenges against patents owned by Chugai, Genentech, and Hoffmann-La Roche, clearing potential patent obstacles to market entry.
The biosimilar competition targets a significant market opportunity, as Roche reported worldwide sales of Actemra® in 2023 of approximately $3 billion.
Setback for Xbrane's Ranibizumab Biosimilar
In contrast to Fresenius Kabi's success, Xbrane Biopharma announced on April 21, 2024, that it received a Complete Response Letter from the FDA regarding Xlucane™ (ranibizumab), its proposed biosimilar of Genentech's Lucentis® (ranibizumab).
According to Xbrane, the FDA's concerns "relate primarily to the reference standard and pre-approval inspections of manufacturing partners' sites." The company emphasized that the FDA has not requested re-inspections or additional studies to demonstrate biosimilarity, and plans to announce a resubmission date following discussions with regulators.
Xlucane™ faces an established competitive landscape, as two interchangeable Lucentis® biosimilars are already approved and marketed in the U.S.: Samsung Bioepis's Byooviz™ (ranibizumab-nuna) and Coherus's Cimerli™ (ranibizumab-eqrn). The combined 2023 sales of Lucentis® by Novartis and Roche were approximately $1.475 billion.
New Herceptin® Biosimilar Approval
Adding to the expanding biosimilar landscape, Accord BioPharma and Shanghai Henlius Biotech announced on April 29, 2024, that the FDA had approved Hercessi™ (trastuzumab-strf), a biosimilar of Genentech's Herceptin® (trastuzumab).
Hercessi™ becomes the sixth Herceptin® biosimilar approved in the U.S. and represents Accord's first U.S. biosimilar approval. The company is building a broader biosimilar portfolio with pending applications for biosimilars of Neupogen® (filgrastim), Neulasta® (pegfilgrastim), and Stelara® (ustekinumab).
The approval targets the Herceptin® market, which generated approximately $1.77 billion in global sales for Roche in 2023.
Market Impact and Future Outlook
These developments highlight the continued maturation of the U.S. biosimilar market, with manufacturers targeting high-value biologics as patents expire and legal barriers are resolved. The entry of biosimilars typically leads to price competition and expanded patient access to important therapies.
For tocilizumab, used in treating rheumatoid arthritis, giant cell arteritis, and cytokine release syndrome among other conditions, the introduction of Tyenne® represents a significant milestone in expanding treatment options and potentially reducing costs.
Similarly, the growing number of trastuzumab biosimilars for HER2-positive breast cancer and metastatic gastric cancer treatments continues to reshape the oncology landscape, while competition in the ophthalmology space for ranibizumab biosimilars addresses the needs of patients with wet age-related macular degeneration and other retinal conditions.
As patent disputes resolve and manufacturing capabilities expand, the biosimilar market is expected to continue its growth trajectory, creating both challenges for reference product manufacturers and opportunities for healthcare systems seeking cost-effective alternatives.
