Eye on Pharma: Interchangeability, Private Labels, and Patent Settlements for Biosimilars

Alvotech/Teva and Biocon Biologics advanced US biosimilar access with FDA interchangeability for ustekinumab biosimilars, Selarsdi and Yesafili, plus broad 2025 formulary coverage for Biocon’s Yesintek.

Alvotech and Teva Secure Interchangeability for Ustekinumab¹

The FDA has approved Selarsdi (ustekinumab-aekn), a biosimilar to Stelara (ustekinumab), as fully interchangeable with the reference product across all approved indications and presentations, effective April 30, 2025. Developed by Alvotech and commercialized in the US by Teva Pharmaceuticals, Selarsdi is approved to treat moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children 6 years and older, as well as moderately to severely active Crohn disease and ulcerative colitis in adults.

Selarsdi is available in various formats, including prefilled syringes, vials for subcutaneous injection, and vials for intravenous infusion. It is produced using the same cell line and continuous perfusion process as Stelara, ensuring consistent quality and performance.

The FDA’s designation of interchangeability allows Selarsdi to be substituted at the pharmacy level, enhancing access and lowering healthcare costs. This approval is part of the broader Teva-Alvotech biosimilars collaboration, which recently launched Simlandi (adalimumab-ryvk), a biosimilar to Humira (adalimumab). Three additional biosimilars under the partnership are currently under FDA review, with decisions expected by late 2025.

Biocon Biologics Gets Private Label Coverage for Another Ustekinumab²

In a separate development, Biocon Biologics announced significant market access progress for Yesintek (ustekinumab-kfce), its FDA-approved biosimilar to Stelara. The company has secured formulary inclusion across major US payers, providing access to over 100 million lives—covering 70% to 80% of the commercial market. Express Scripts, Cigna, UnitedHealthcare, CVS Health, and Optum Rx have all added Yesintek to their formularies starting in 2025, alongside other regional plans including BCBS Michigan and Florida Healthcare Plan, where it is the exclusive ustekinumab product.

Approved by the FDA in December 2024, Yesintek treats Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. It is available in the same formulations as Stelara, including prefilled syringes and vials. The biosimilar has demonstrated comparable safety, efficacy, and immunogenicity to its reference product in phase 3 studies.

Biocon’s leadership emphasized this as a major milestone in its US expansion, reflecting payer confidence in the company’s scientific rigor and supply reliability, and reinforcing efforts to increase access to cost-effective biologics.

Regeneron and Biocon Settle Over Aflibercept Biosimilar³

In more Biocon news, Biocon Biologics has reached a settlement and license agreement with Regeneron, paving the way for the US commercialization of Yesafili (aflibercept-jbvf), an interchangeable biosimilar to Eylea (aflibercept). Yesafili is a vascular endothelial growth factor inhibitor used to treat various ophthalmologic conditions, like age-related macular degeneration and macular edema.

The agreement resolves ongoing patent litigation and an appeal concerning US patent US11084865, allowing Biocon to launch Yesafili in the US in the second half of 2026, or potentially earlier under certain conditions. The settlement terms remain confidential.

Yesafili was approved by the FDA in May 2024 as an interchangeable biosimilar, meaning it can be substituted for Eylea at the pharmacy without prescriber approval, similar to generic drugs. Biocon also secured a separate agreement with Bayer and Regeneron in Canada, enabling a launch there by July 1, 2025. These agreements support Biocon’s broader efforts to expand access to more affordable treatment options in ophthalmology across North America.

References

1. Teva and Alvotech announce FDA approval of interchangeability for Selarsdi™ (ustekinumab-aekn) with Stelara^® (ustekinumab). Press release; Alvotech. May 5, 2025. Accessed May 9, 2025. https://investors.alvotech.com/news-releases/news-release-details/teva-and-alvotech-announce-fda-approval-interchangeability

2. Biocon Biologics secures strong market access coverage for Yesintek™ in the United States covering 100+ million lives. Press release; Biocon Biologics. May 5, 2025. Accessed May 9, 2025. https://www.bioconbiologics.com/biocon-biologics-secures-strong-market-access-coverage-for-yesintek-in-the-united-states-covering-100-million-lives/

3. Harp MD. Biocon reaches settlement agreement with Regeneron to launch aflibercept biosimilar, Yesafili, in the US. Ophthalmology Times. April 15, 2025. Accessed May 9, 2025. https://www.ophthalmologytimes.com/view/biocon-achieves-settlement-agreement-with-regeneron-to-launch-aflibercept-biosimilar-yesafili-in-the-us