Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships

As the FDA granted interchangeable status to 2 biosimilars, Alvotech and Advanz Pharma have expanded their European biosimilar partnership to include new candidates targeting high-value biologics.

As the FDA granted interchangeable status to 2 biosimilars, Alvotech and Advanz Pharma have expanded their European biosimilar partnership to include new candidates targeting high-value biologics.

Two Biosimilars Are Deemed Interchangeable

Otulfi (ustekinumab-aauz) was 1 of 2 biosimilars recently granted interchangeable status by the FDA, meaning pharmacists can substitute it for Stelara (ustekinumab) without needing prescriber approval, depending on state laws.¹

Developed by Fresenius Kabi and Formycon AG, Otulfi is used to treat conditions like Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis in adults and kids 6 years and older. It’s the first product from the Fresenius-Formycon partnership to launch in the US, and it’s available in both injection and infusion forms.

The FDA’s decision was based on data showing Otulfi is just as safe and effective as Stelara, even for patients who switch between the 2 products. The approval reflects newer FDA guidance that allows biosimilars to be designated interchangeable based on existing approval data, without requiring separate switching studies.

The other biosimilar to gain this label recently was Hadlima (adalimumab-bwwd), which references Humira (adalimumab).² The new designation concerns both the high- and low-concentration versions of the biosimilar.

The decision was backed by data from a clinical trial in patients with plaque psoriasis, showing that those who switched between Hadlima and Humira had comparable results in terms of drug levels, safety, and effectiveness. Originally approved in 2019, Hadlima has been available in both concentrations since 2023. Its broader interchangeability could help improve access to treatment and potentially reduce out-of-pocket costs, especially given data showing patients may pay significantly more for Humira.

Like Otulfi, Hadlima treats several inflammatory conditions like rheumatoid arthritis, Crohn disease, ulcerative colitis, and psoriasis.

Alvotech and Advanz Pharma Expand Partnership

Alvotech and Advanz Pharma expanded their biosimilar partnership in late May 2025 to include 3 new biosimilar candidates. Under the deal, Alvotech took on development and supply responsibilities, while Advanz Pharma was set to handle registration and commercialization across Europe. Two of the new biosimilars target Ilaris (canakinumab) for various inflammatory diseases and Kesimpta (ofatumumab) for relapsing multiple sclerosis. The third product remains undisclosed. The agreement included up to $180 million in development and commercial milestone payments, along with revenue sharing.

This expansion built on their existing collaboration, which already covered biosimilars to high-profile biologics like Xolair (omalizumab), Simponi (golimumab), Entyvio (vendolizumab), Eylea (aflibercept), Dupixent (dupilumab), Taltz (ixekizumab), and Tremfya (guselkumab). Their commercial reach spans all European Union/European Economic Area countries, the UK, and Switzerland—with some rights also extending to Canada, Australia, and New Zealand.

Executives from both companies emphasized the partnership’s role in increasing access to specialty and rare-disease treatments across Europe. Together, the products covered by the partnership represent a market worth at least $13.8 billion.

References

1. FDA grants interchangeable designation to Fresenius Kabi’s biosimilar Otulfi (ustekinumab-aauz). Press release. Fresenius Kabi; May 19, 2025. Accessed May 29, 2025. https://www.businesswire.com/news/home/20250519113313/en/FDA-Grants-Interchangeable-Designation-to-Fresenius-Kabis-biosimilar-Otulfi-ustekinumab-aauz

2. US Food and Drug Administration (FDA) grants interchangeability designation to Samsung Bioepis and Organon Hadlima (adalimumab-bwwd) injection. Press release. Organon; May 27, 2025. Accessed May 29, 2025. https://www.businesswire.com/news/home/20250527970852/en/US-Food-and-Drug-Administration-FDA-Grants-Interchangeability-Designation-to-Samsung-Bioepis-and-Organon-HADLIMA-adalimumab-bwwd-Injection

3. Alvotech and Advanz Pharma extend strategic partnership to commercialize three additional biosimilars in Europe. Press release. Alvotech; May 28, 2025. Accessed May 29, 2025. https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-advanz-pharma-extend-strategic-partnership-0