New Approvals Expand Access to Biosimilars for Ophthalmology, Bone, and Joint Conditions

Recent weeks have demonstrated global momentum in the regulatory advancement of biosimilars, with key approvals and positive opinions emerging from the US, Europe, and Canada. These developments are poised to enhance access to affordable, high-quality therapeutic options for individuals with various complex conditions, including autoimmune disorders, bone diseases, and ophthalmic conditions, which holds substantial implications for managed health care systems.

FDA Review Advances

The FDA accepted the biologics license application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab).1 This biosimilar, developed by Bio-Thera Solutions, aims to treat several autoimmune conditions, including moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active ulcerative colitis in adults. The BLA, submitted by Bio-Thera’s US commercialization partner Accord BioPharma, also requested that BAT2506 be declared interchangeable with Simponi.

The application was supported by a comprehensive analytical, nonclinical, and clinical data package, which included a phase 3 study in patients with active psoriatic arthritis that demonstrated similar efficacy, safety, and immunogenicity compared with the reference product.

European Regulatory Milestones

Europe has also experienced significant regulatory progress, particularly in the ophthalmic biosimilar space. Alteogen, a Republic of Korea–based biopharmaceutical company, received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for Eyluxvi (ALT-L9) on July 24, 2025.2 Eyluxvi is a biosimilar to Eylea (aflibercept), which is widely used for conditions such as wet age-related macular degeneration (wet AMD) and diabetic retinopathy.

The recommendation followed a rigorous phase 3 trial involving 431 patients across 12 countries, which confirmed therapeutic equivalence to Eylea in terms of efficacy, safety, and immunogenicity. This positive CHMP opinion is a crucial step towards European Commission (EC) approval, which is anticipated within months, coinciding with Eylea’s substance patent expiration in 2025. The European market for aflibercept generated over €5 billion in annual sales before generic competition, presenting a significant opportunity for early entrants. Alteogen's intellectual property strategy, including patents for ALT-L9's prefilled syringe formulation and culture methods in the US and European Union, further solidifies its competitive edge.

Furthermore, the EC approved Denbrayce, a denosumab biosimilar referencing Xgeva.3 Denbrayce was approved for preventing skeletal-related events in adult patients with advanced malignancies involving the bone and in adult and skeletally mature adolescent patients with giant cell tumor of the bone. This regulatory decision followed a positive recommendation from the EMA CHMP. The EC also approved Izamby, the same denosumab biosimilar but with the same indications as Prolia: osteoporosis in postmenopausal women and in men at increased risk of fractures.

Canadian Approvals

Canada has emerged as a key region for new biosimilar introductions, particularly in ophthalmology. Apotex announced that Health Canada had approved Aflivu (aflibercept), a biosimilar to Eylea.4 This marked Apotex’s first ophthalmic biosimilar and its fourth biosimilar overall since 2016, reflecting the company's commitment to expanding its biologics portfolio.

Like Eyluxvi, Aflivu is indicated for the treatment of wet AMD as well as macular edema secondary to central or branch retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization. Physicians highlighted that a broader range of therapeutic options, including affordable alternatives like Aflivu, can empower them to tailor care to individual patient needs.

In a separate but related development, Biocon Biologics also received Health Canada approval for Yesafili (aflibercept 2 mg), another biosimilar to Eylea.5 Notably, Yesafili was the first biosimilar to Eylea to be approved by Health Canada. This approval was supported by comprehensive analytical, nonclinical, and clinical data demonstrating high similarity in quality, safety, and efficacy to Eylea. Yesafili was scheduled for a Canadian launch on July 4, 2025, and represents Biocon’s 10th biosimilar to be commercialized worldwide.

As patent expirations continue and regulatory pathways streamline, the biosimilars market is poised for sustained growth, enabling health care providers to offer high-quality care with potentially significant cost savings, ultimately benefiting patients and health care budgets alike.

References

1. Bio-Thera Solutions announces FDA accepts biologics license application for BAT2506, a proposed biosimilar to Simponi. News release. Bio-Thera Solutions. July 16, 2025. Accessed July 28, 2025. https://www.prnewswire.com/news-releases/bio-thera-solutions-announces-fda-accepts-biologics-license-application-for-bat2506-a-proposed-biosimilar-to-simponi-302506633.html

2. Doherty K. Denosumab biosimilar earns European approval in advanced malignancies involving the bone and giant cell tumors of the bone. OncLive®. July 2, 2025. July 28, 2025. https://www.onclive.com/view/denosumab-biosimilar-earns-european-approval-in-advanced-malignancies-involving-the-bone-and-giant-cell-tumors-of-the-bone

3. Hale V. Alteogen's strategic positioning in the biosimilars market with positive CHMP opinion for Eyluxvi (ALT-L9). AI Invest. July 28, 2025. Accessed July 28, 2025. https://www.ainvest.com/news/alteogen-strategic-positioning-biosimilars-market-positive-chmp-opinion-eyluxvi-alt-l9-2507/

4. Apotex receives Health Canada approval for Aflivu, a biosimilar to Eylea, available in pre-filled syringe and vial formats. News release. Apotex. July 2, 2025. Accessed July 28, 2025. https://www.prnewswire.com/news-releases/apotex-receives-health-canada-approval-for-aflivu-a-biosimilar-to-eylea-available-in-pre-filled-syringe-and-vial-formats-302496912.html

5. Harp MD. Health Canada approves Biocon's Yesafili, biosimilar to Eylea. Ophthalmology Times®. July 1, 2025. Accessed July 28, 2025. https://www.ophthalmologytimes.com/view/health-canada-approves-biocon-s-yesafili-biosimilar-to-eylea