- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
EMA Begins Review of Samsung Bioepis' Ranibizumab
The European Medicines Agency (EMA) regulatory review advances a pact between Samsung Bioepis and Biogen announced last year.
The European Medicines Agency has initiated review of a proposed ranibizumab biosimilar (SB11) from Samsung Bioepis. The product candidate references Roche’s Lucentis and would treat retinal vascular disorders, a leading cause of blindness.
Samsung Bioepis developed the product and under a commercialization agreement announced in November 2019, Biogen will handle the marketing of both SB11 and an aflibercept biosimilar (SB15), which is an ophthalmology agent referencing Eylea, a Regeneron Pharmaceuticals/Bayer product. Biogen would manage sales of both products in the United States, Japan, Europe, Canada, and Australia.
“We believe SB11 has the potential to be a meaningful new offering for patients with retinal vascular disorders, and we look forward to continued engagement with the EMA throughout the review process,” Hee Kyung Kim, senior vice president for the Clinical Sciences and Regulatory Affairs Division at Samsung Bioepis, said in a statement.
Ranibizumab is an anti–vascular endothelial growth factor (VEGF) therapy that is used to block the excess development of blood vessels in the eye, which can contribute to the development of disease and tumor formation.
Aflibercept is used to treat wet macular degeneration and metastatic colorectal cancer. It is also an anti-VEGF product.
Samsung Bioepis is based in Incheon, Republic of Korea, and Biogen is in Cambridge, Massachusetts.
The Banking of Biosimilars: Insights From a Leading Health Economist
February 4th 2025Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Insights from Festival of Biologics: Dracey Poore Discusses Cardinal Health’s 2024 Biosimilar Report
May 19th 2024The discussion highlights key emerging trends from the Festival of Biologics conference and the annual Cardinal Health Biosimilars Report, including the importance of sustainability in the health care landscape and the challenges and successes in biosimilar adoption and affordability.
Cost-Benefits, Efficacy of Biosimilar Ranibizumab vs Aflibercept for nAMD in Japan
January 22nd 2025When compared with reference aflibercept, a biosimilar ranibizumab was a clinically effective and cost-saving alternative in a study assessing Japanese patients with different subtypes of neovascular age-related macular degeneration (nAMD).
