Biosimilar Business Recap: Updates on Tocilizumab, Omalizumab, and Ranibizumab Products

Discover the latest advancements in biosimilars, including tocilizumab's new indication, and partnerships for omalizumab and ranibizumab.

The FDA expanded an indication for a tocilizumab biosimilar to include cytokine release syndrome, Kashiv BioSciences and MS Pharma partnered on an omalizumab biosimilar for the Middle East and North Africa, and Lupin teamed with Sandoz on a ranibizumab biosimilar to improve global access to affordable biologics.

Tocilizumab Biosimilar Indication Expansion

The FDA has expanded the indication for the intravenous (IV) formulation of tocilizumab-anoh (Avtozma; Celltrion), a biosimilar to Actemra, to include treatment of cytokine release syndrome (CRS) in adults and children 2 years and older.1 This aligns Avtozma IV’s indications fully with the reference product, broadening therapeutic options for a potentially life-threatening complication of chimeric antigen T-cell therapy. CRS, caused by excessive release of proinflammatory cytokines like interleukin (IL)-6, can lead to severe inflammation, organ damage, and multi-organ failure. Tocilizumab-anoh, an IL-6 receptor antagonist, blocks IL-6 signaling to mitigate the inflammatory cascade while preserving the effects of immunotherapy. The FDA decision was supported by robust biosimilarity data, including a global phase 3 trial in rheumatoid arthritis, which also underpinned earlier approvals for multiple inflammatory conditions. Avtozma IV will be available in the US on August 31, 2025, following a patent settlement with Genentech, offering a cost-effective alternative that may reduce health care costs.

New Deal for Omalizumab Biosimilar

Kashiv BioSciences and MS Pharma have signed a license and supply agreement for ADL-018, Kashiv’s biosimilar candidate to Xolair (omalizumab), covering the Middle East and North Africa (MENA) region.2 Xolair generated about $4.5 billion in global sales and $60 million in MENA in 2024, according to IQVIA. Under the deal, Kashiv will handle product development, while MS Pharma will manage licensing, distribution, and commercialization, with the option for local manufacturing at its biologics facility in Saudi Arabia.

The companies emphasized their shared commitment to expanding access to biologic therapies and growing their specialty portfolios. MS Pharma aims to submit for regulatory approval in MENA in Q4 2025. Omalizumab is used to treat chronic urticaria, severe allergic asthma, chronic rhinosinusitis with nasal polyps, and immunoglobulin E–mediated food allergies. ADL-018 remains investigational and has not yet been approved or deemed biosimilar by any regulatory authority.

Lupin and Sandoz Partner on Ranibizumab Biosimilar

Lupin has signed a licensing agreement with Sandoz to develop and commercialize a biosimilar version of ranibizumab, a treatment for retinal disorders such as age-related macular degeneration and diabetic macular edema.3 Under the arrangement, Lupin will oversee manufacturing and regulatory submissions, while Sandoz will manage commercialization in select global markets, with exclusive and semi-exclusive rights in those regions.

The partnership aims to improve patient access to affordable therapies for vision-threatening conditions. Lupin will focus on meeting stringent regulatory requirements during production and filing, and Sandoz will utilize its strong market presence to ensure effective distribution. The collaboration is expected to expand treatment availability in key regions and contribute to lowering health care costs associated with retinal disease management.

References

1. Serani S. FDA expands approval for tocilizumab biosimilar to treat CRS. Targeted Oncology™️. August 7, 2025. August 12, 2025. https://www.targetedonc.com/view/fda-expands-approval-for-tocilizumab-biosimilar-to-treat-crs

2. Levy S. Kashiv BioSciences, MS Pharma ink deal for Xolair biosimilar. Drug Store News. August 12, 2025. Accessed August 12, 2025. https://drugstorenews.com/kashiv-biosciences-ms-pharma-ink-deal-xolair-biosimilar

3. Chian M. Lupin Partners with Sandoz to develop and commercialize biosimilar ranibizumab for retinal disorders. Gene Online. August 12, 2025. Accessed August 12, 2025. https://www.geneonline.com/lupin-partners-with-sandoz-to-develop-and-commercialize-biosimilar-ranibizumab-for-retinal-disorders/