Eye on Pharma: CHMP Aflibercept Decision; Omalizumab Results; Dupilumab Biosimilar Deal

Alvotech and Advanz Pharma have announced a positive Committee for Medicinal Products for Human Use (CHMP) opinion for their aflibercept biosimilar, AVT06, aiming for European approval. Concurrently, Amneal Pharmaceuticals shared positive clinical trial results for Kashiv BioSciences' omalizumab biosimilar, ADL-018, targeting the US market, while Bio-Thera Solutions and SteinCares have partnered to bring a dupilumab biosimilar to Latin America.

CHMP Green Lights Aflibercept Candidate

Alvotech and Advanz Pharma announced that the European Medicines Agency's CHMP has issued a positive opinion, recommending approval for AVT06, a proposed biosimilar to Eylea (aflibercept, 2 mg).¹ The decision brings the companies closer to marketing the biosimilar in the European Economic Area for various eye conditions, including wet age-related macular degeneration and diabetic macular edema. Alvotech is responsible for development and supply, while Advanz Pharma handles registration and commercialization in Europe.

“CHMP’s positive opinion takes us a step closer to being able to market our proposed biosimilar in Europe, which is excellent news for patients and their caregivers,” commented Joseph McClellan, chief scientific officer of Alvotech. The recommendation follows positive results from a 2024 clinical study confirming AVT06's therapeutic equivalence to Eylea, a drug with global sales of approximately $9 billion in 2024.

AVT06 is a recombinant fusion protein designed to bind vascular endothelial growth factors, thereby inhibiting abnormal blood vessel growth and vascular permeability, which are key mechanisms in the progression of various eye disorders. Alvotech is also developing AVT29, a biosimilar candidate for Eylea HD (aflibercept, 8 mg), and Advanz Pharma holds the distribution rights for both biosimilar candidates in the same European territories. The European Commission will make the final decision on European approval for AVT06.

Amneal Shares Results for Omalizumab Biosimilar

Amneal Pharmaceuticals has announced positive topline results from a pivotal clinical trial for ADL-018, a proposed biosimilar to reference omalizumab (Xolair), developed by Kashiv BioSciences.² The study, involving patients with chronic idiopathic or spontaneous urticaria, successfully met its primary and secondary end points, demonstrating therapeutic equivalence and comparable safety between ADL-018 and reference omalizumab. This represents a crucial step toward making an omalizumab biosimilar available in the US.

Amneal anticipates submitting a biologics license application to the FDA in Q4 2025 and holds exclusive US commercialization rights. With Xolair's US annual sales reaching approximately $3.9 billion, ADL-018 is poised to be a significant addition to Amneal's biosimilar portfolio, enhancing access to this vital treatment.

Omalizumab is a humanized monoclonal antibody targeting free IgE indicated for various allergic conditions, including severe allergic asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria. Expanded access to omalizumab could significantly benefit patients and health care systems by offering a more affordable treatment alternative for these conditions.

Bio-Thera and SteinCares Join Forces on Dupilumab

Bio-Thera Solutions and SteinCares have forged a new agreement to commercialize a proposed dupilumab biosimilar across Latin America. This marks their fourth collaboration, underscoring a shared commitment to enhancing access to affordable, high-quality therapies in the region. Bio-Thera will handle product development and supply, while SteinCares will manage registration and commercialization throughout Latin America.

Mitchell Waserstein, CEO of SteinCares, emphasized that the partnership reinforces their position as a leading biosimilar platform in the region, aiming to make advanced therapies more accessible and affordable. Given dupilumab's status as 1 of the top 5 medicines globally by annual sales, this biosimilar represents a significant milestone for SteinCares' expansion, potentially aiding in the treatment of chronic inflammatory conditions in both adults and children.

References

1. European Medicines Agency recommends market approval of AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept). Press release. Alvotech; June 23, 2025. Accessed June 26, 2025. https://www.globenewswire.com/news-release/2025/06/23/3103152/0/en/European-Medicines-Agency-Recommends-Market-Approval-of-AVT06-Alvotech-s-Proposed-Biosimilar-to-Eylea-aflibercept.html

2. Amneal highlights positive topline results from confirmatory clinical study of biosimilar candidate to Xolair (omalizumab), developed by Kashiv BioSciences. Press release. Amneal Pharmaceuticals; June 25, 2025. Accessed June 26, 2025. https://www.globenewswire.com/news-release/2025/06/25/3105002/0/en/Amneal-Highlights-Positive-Topline-Results-from-Confirmatory-Clinical-Study-of-Biosimilar-Candidate-to-XOLAIR-R-omalizumab-Developed-by-Kashiv-BioSciences.html

3. Bio-Thera Solutions and SteinCares expand partnership to commercialize biosimilars for treatment of inflammatory diseases across Latin America. Press release. Bio-Thera Solutions; June 25, 2025. Accessed June 26, 2025. https://www.prnewswire.com/news-releases/bio-thera-solutions-and-steincares-expand-partnership-to-commercialize-biosimilars-for-treatment-of-inflammatory-diseases-across-latin-america-302490693.html