- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Samsung Bioepis Announces New Biosimilar Partnership, Regulatory Updates
Samsung Bioepis provided multiple updates on its biosimilar projects, including a new partnership for its aflibercept biosimilar candidate as well as regulatory news in the European Union and Republic of Korea.
Samsung Bioepis provided multiple updates on its biosimilar projects, including a new partnership for its aflibercept biosimilar candidate as well as regulatory news in the European Union and Republic of Korea.
Image credit: Pitchayaarch - stock.adobe.com
Partnership With Samil Pharmaceutical and an Approval
Samsung Bioepis has partnered with Samil Pharmaceutical to bring SB15, an aflibercept biosimilar, to the Korean market, according to a report from Korea Biomedical Review.
SB15 references Eylea, an anti–vascular endothelial growth factor agent used to treat ophthalmic conditions, such as diabetic macular edema and wet age-related macular degeneration. Eylea accumulated $9.7 billion globally in 2023.
The new partnership for SB15 marks the second in the ophthalmology space. In June 2022, the companies agreed on a marketing partnership concerning Amelivu, a ranibizumab product that has been on the Korean market since January 2023.
"Through this agreement, we will further enhance the synergy between our R&D [research and development] capabilities and Samil Pharmaceutical's sales and marketing expertise," Samsung Bioepis CEO Han-sung Ko said. "We will strive to provide more domestic patients with ophthalmic diseases with treatment opportunities through high-quality biopharmaceuticals."
Shortly after the partnership was announced, SB15 (Aflilivu) received approval from the Republic of Korea’s Ministry of Food and Drug Safety. Samsung Bioepis is the first company to have obtained approval for both a ranibizumab biosimilar and an aflibercept biosimilar in the Republic of Korea.
CHMP Positive Opinion for Ustekinumab Biosimilar
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for approval for SB17 (Pyzchiva), Samsung Bioepis’ ustekinumab biosimilar candidate. If the product is granted marketing authorization by the European Commission, SB17 would be the second ustekinumab biosimilar approved for the region.
Ustekinumab is a human IgG1κ monoclonal antibody that inhibits IL-12 and IL-23. The committee granted the positive opinion for Pyzchiva to be used in the treatment of plaque psoriasis, Crohn disease, ulcerative colitis, pediatric plaque psoriasis, and psoriatic arthritis.
When the biosimilar enters the European market, Sandoz will be responsible for commercialization of Pyzchiva throughout the region as well as the US, Canada, the European Economic Area, Switzerland, and the United Kingdom.
Perceptions of Biosimilar Switching Among Veterans With IBD
December 2nd 2024Veterans with inflammatory bowel disease (IBD) prioritize shared decision-making, transparency, and individualized care in biosimilar switching, favoring delayed switching for severe cases and greater patient control.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
Aflibercept Biosimilar MYL-1701P Provides Equivalence in DME Therapy
November 27th 2024The study findings demonstrate that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.
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.
The Rebate War: How Originator Companies Are Fighting Back Against Biosimilars
November 25th 2024Few biologics in the US have multiple biosimilar competitors, but originator biologics respond quickly to competition by increasing rebates and lowering net prices, despite short approval-to-launch timelines for biosimilars.
