Biosimilar Makers Push Forward on Regulatory and Commercial Fronts

Biosimilar developers across the globe advanced their pipelines and portfolios in recent weeks, with new FDA indication expansions, a European product launch, and a fresh regulatory acceptance, signaling continued momentum toward expanded patient access to biologic medicines.

FDA expands Tofidence uses, Teva launches Eylea biosimilar in Europe, and Alvotech nears Entyvio rival—accelerating biosimilar access and savings. | Image credit: Mongkolchon - stock.adobe.com

Tofidence Gains 2 New Indications in US

Organon announced that the FDA approved a supplemental Biologics License Application (sBLA) for Tofidence (tocilizumab-bavi), a biosimilar referencing Actemra (tocilizumab), expanding the product's approved indications to include 2 serious conditions. The newly approved indications cover treatment of adults and pediatric patients 2 years of age and older with chimeric antigen receptor (CAR) T cell–induced severe or life-threatening cytokine release syndrome (CRS), as well as hospitalized adult and pediatric patients aged 2 years and older with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, noninvasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

Tofidence, the first approved tocilizumab biosimilar entrant in the US market, launched in May 2024 and was already indicated for moderately to severely active rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (PJIA), and systemic juvenile idiopathic arthritis (SJIA). Organon acquired the regulatory and commercial rights to Tofidence in the US in 2025. The expanded label positions the product as a lower-cost alternative to the reference biologic in critical care and oncology support settings, where biosimilar adoption could meaningfully reduce costs for health systems managing high-acuity patients.

Teva Brings Aflibercept Biosimilar to European Markets

Teva Pharmaceutical Industries announced the European launch of Ahzantive (aflibercept), a biosimilar to Eylea (aflibercept), marking the company's entry into the ophthalmology biosimilar space. The launch of Ahzantive prefilled syringes began in May 2026 across several European markets, including France, Germany, Spain, and the Netherlands, with Teva expecting to launch in additional markets later in the year.

Ahzantive received European Commission approval in 2025 for treatment of neovascular age-related macular degeneration and other serious retinal diseases, including diabetic macular edema, visual impairment due to myopic choroidal neovascularization, and macular edema following retinal vein occlusion. The launch followed Teva's semi-exclusive commercialization agreement with Klinge Biopharma GmbH and Formycon AG in major parts of Europe and Israel. Teva reported it has one of the world's largest biosimilar portfolios globally, with 11 biosimilars on the market and 13 products in its pipeline across therapeutic areas, including oncology, immunology, ophthalmology, and respiratory care. The European ophthalmology biosimilar space is considered a significant opportunity for cost savings given the widespread chronic use of anti-vascular endothelial growth factor agents for retinal disease management.

FDA Accepts Alvotech's Entyvio Biosimilar Application

Rounding out a busy stretch for the biosimilar sector, Alvotech announced that the FDA accepted for review a BLA for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab) for intravenous administration in adults with inflammatory bowel disease. The BLA submission is supported by a comprehensive data package, including analytical, pharmacokinetic, and immunogenicity data generated to demonstrate biosimilarity between AVT16 and the reference product.

If the FDA approves AVT16 with an interchangeable designation, it could be substituted for Entyvio at pharmacies without prescriber intervention, a status that carries significant commercial advantages in the US market. Under a partnership with Teva, Alvotech is responsible for development and manufacturing of AVT16, while Teva is responsible for commercialization. Alvotech shares jumped approximately 12% in premarket trading following the announcement. Separately, in February 2026, Alvotech announced positive results from a pivotal pharmacokinetic study for AVT80, a proposed biosimilar to Entyvio for subcutaneous administration, suggesting the company is pursuing multiple pathways to compete in the vedolizumab market.

References

1. Organon secures US Food and Drug Administration approval expanding indications for Tofidence (tocilizumab-bavi) in cytokine release syndrome (CRS) and pediatric COVID-19. Press release. Organon; June 10, 2026. https://www.businesswire.com/news/home/20260610519993/en/Organon-Secures-US-Food-and-Drug-Administration-Approval-Expanding-Indications-for-TOFIDENCE-tocilizumab-bavi-in-Cytokine-Release-Syndrome-CRS-and-Pediatric-COVID-19
2. Teva expands European biosimilars portfolio with launch of Ahzantive (aflibercept) biosimilar to Eylea. Press release. Teva Pharmaceutical Industries Ltd; June 4, 2026. https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Teva-Expands-European-biosimilars-portfolio-with-launch-ofAHZANTIVEaflibercept-biosimilar-to-Eylea/default.aspx
3. Alvotech announces FDA acceptance of biologics license application for AVT16, a proposed interchangeable biosimilar to Entyvio. Press release. Alvotech; June 8, 2026. https://www.globenewswire.com/news-release/2026/06/08/3307832/0/en/alvotech-announces-fda-acceptance-of-biologics-license-application-for-avt16-a-proposed-interchangeable-biosimilar-to-entyvio.html