Global Biosimilars Market Sees Gains in Access and Pipeline Expansion

The global biosimilar industry experienced significant momentum in early October 2025, driven by a key US product launch, strategic international partnerships aimed at improving affordability, and major regulatory filings for a high-value asthma and allergy treatment. These updates reflect continued efforts by biopharmaceutical companies to increase patient access and reduce the economic burden on health care systems worldwide.

Celltrion Expands US Immunology Access

On October 2, 2025, Celltrion announced the launch of its Avtozma (tocilizumab-anoh) intravenous (IV) formulation in the US, providing a new treatment option for people living with serious immune-mediated conditions. Avtozma, a proposed biosimilar to the reference product Actemra (tocilizumab), had received approval from the FDA in January 2025. Following the initial approval, the FDA approved an expanded indication for the IV formulation in July 2025 for the treatment of adult and pediatric patients 2 years and older experiencing cytokine release syndrome.

The biosimilar is now available to patients across all the same indications as the reference product, including individuals with rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. It also treats hospitalized adult patients with COVID-19 who require supplemental oxygen or more intensive support, such as mechanical ventilation or extracorporeal membrane oxygenation.

This launch marked Celltrion’s seventh FDA-approved biosimilar and its fifth immunology biologic. The drug acts as an IL-6 receptor antagonist, which expanded Celltrion’s immunology portfolio beyond tumor necrosis factor-α and IL-12/23 inhibitors.

Celltrion’s news release noted that the availability of a tocilizumab biosimilar offers clinicians additional options for managing disease and maintaining continuity of care for people living with these conditions. The company says it is committed to supporting patients receiving Avtozma IV with comprehensive patient support resources and co-pay assistance for eligible individuals with commercial insurance.

Partnership Boosts Affordability in MENA Region

In a key move to expand biosimilar availability across the Middle East and North Africa (MENA) region, Hikma Pharmaceuticals and its long-standing partner Celltrion signed exclusive licensing agreements. The agreements focused on introducing 6 new biosimilar treatments to MENA markets. These products were aimed at broadening access to affordable biologics for people requiring treatment in key therapeutic areas, including allergic diseases, oncology, immune diseases, ophthalmology, and skeletal-related disorders.

Hikma secured exclusive commercialization rights for all MENA markets under the deal, while Celltrion maintained responsibility for the treatments’ manufacturing, supply, and development. Hikma’s executive vice chairman noted that these high-quality biosimilar treatments had the potential to significantly improve the quality of life for patients living with chronic, debilitating, or life-threatening conditions. By offering cost-effective alternatives, the partnership aims to reduce burdens on health care systems and enhance outcomes for people in the region.

Omalizumab Biosimilar Submissions Signal Market Competition

In October 2025, Kashiv BioSciences announced an advance in its pipeline, submitting a biologics license application (BLA) for ADL-018, a proposed biosimilar to Xolair (omalizumab), to the FDA. Simultaneously, the European Medicines Agency accepted the marketing authorization application for ADL-018. Omalizumab, a humanized monoclonal antibody, is indicated for individuals experiencing conditions such as chronic spontaneous urticaria, moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy.

This therapeutic market is large, with global annual sales for the reference product totaling approximately $5.5 billion for the 12 months ending in June 2025, including $4.1 billion in the US and $1.0 billion in the European Union.

Kashiv is developing ADL-018 in partnership with Alvotech. Kashiv’s BLA submission positions ADL-018 to be among the first wave of biosimilar entrants in this large market. Amneal Pharmaceuticals, a partner, anticipated that the product would serve as a significant growth catalyst and announced plans to launch 5 additional biosimilars between 2026 and 2027, highlighting biosimilars as a critical growth driver for the company.

References

1. Celltrion launches Avtozma (tocilizumab-anoh) intravenous (IV) formulation in the United States. News release. Celltrion. Oct 02, 2025. Accessed October 7, 2025. https://www.prnewswire.com/news-releases/celltrion-launches-avtozma-tocilizumab-anoh-intravenous-iv-formulation-in-the-united-states-302570229.html
2. Kashiv Biosciences announces submission of biologics license application to U.S. FDA and acceptance of market authorization application by european medicines agency for ADL-018, a proposed biosimilar to Xolair (omalizumab). News release. Kashiv Biosciences. October 6, 2025. Accessed October 7, 2025. https://www.businesswire.com/news/home/20250930481480/en/Kashiv-Biosciences-Announces-Submission-of-Biologics-License-Application-to-U.S.-FDA-and-Acceptance-of-Market-Authorization-Application-by-European-Medicines-Agency-for-ADL-018-a-Proposed-Biosimilar-to-XOLAIR-omalizumab
3. Hikma, Celltrion boost partnership to expand biosimilar access in MENA. News release. Hikma Pharmaceuticals. July 10, 2025. Accessed October 7, 2025. https://www.middle-east-online.com/en/hikma-celltrion-boost-partnership-expand-biosimilar-access-mena