- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
FDA Accepts Ranibizumab BLA From Samsung Bioepis and Biogen
The FDA's acceptance of the biologics license application (BLA) moves the companies one step closer to entering the US ophthalmology treatment sphere with a biosimilar.
Samsung Bioepis and Biogen said the FDA has accepted for review their biologics license application for a ranibizumab biosimilar candidate (SB11), referencing Lucentis, a Genentech product. The drug is an anti–vascular endothelial growth factor treatment for retinal vascular disorders, a leading cause of blindness.
SB11 was developed by Samsung Bioepis and Biogen is the commercialization partner, according to an agreement the companies signed in November 2019.
“The FDA filing acceptance for SB11 brings us a step closer to our goal of being able to offer affordable treatment options for people with retinal vascular disorders,” said Hee Kyung Kim, senior vice president and Clinical Sciences Division and Regulatory Affairs team leader for Samsung Bioepis.
The European Medicines Agency accepted the marketing application for SB11 in October 2020. The corporate partners already market several biosimilars on the European market, including an etanercept (Benepali), adalimumab (Imraldi), and infliximab (Flixabi).
Samsung Bioepis and Biogen also plan to bring an aflibercept biosimilar (SB15) to market in the United States, Canada, Europe, Japan, and Australia. In the United States, aflibercept (Eylea) is indicated for the treatment of macular degeneration, macular edema, and diabetic retinopathy.
Escaping the Void: All Things Biosimilars With Craig & G
May 4th 2025To close out the Festival of Biologics, Craig Burton and Giuseppe Randazzo from the Association for Accessible Medicines and the Biosimilars Council tackle the current biosimilar landscape and how the industry can emerge from the "biosimilar void."
Will the FTC Be More PBM-Friendly Under a Second Trump Administration?
February 23rd 2025On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.
Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships
May 29th 2025The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.
