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Eye on Pharma: New Clinical Trials, International Approvals for Samsung Bioepis


Samsung Bioepis has gained government clearance to begin a phase 3 clinical trial of its ranibizumab biosimilar in the Republic of Korea.

Samsung Bioepis has gained government clearance to begin a phase 3 clinical trial of its ranibizumab biosimilar in the Republic of Korea.

According to Korea Biomedical Review, the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s phase 3 clinical trial for SB11, a biosimilar product referencing Roche’s Lucentis, which is approved to treat neovascular age-related macular degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema (DME), and diabetic retinopathy in patients with DME. The multi-center domestic trial will comprise 140 patients who have AMD.

Samsung Bioepis is not alone in seeking a share of the market for Lucentis; US-based Pfenex and the German company Formycon are also developing biosimilar ranibizumab.

This week, Samsung Bioepis also gained MFDS approval to sell its adalimumab biosimilar, SB5, in the Republic of Korea. Samsung Bioepis gained a marketing authorization for the same drug, referenced on AbbVie’s blockbuster Humira, from the European Commission (EC) on August 24, 2017. The company plans to sell its biosimilar as Imraldi in the European Union.

News of Samsung Bioepis’ ranibizumab trial and adalimumab approval follow last week’s progress for its biosimilar trastuzumab, SB3, referenced on Herceptin. On Friday, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion of the drug.

On EC clearance, Samsung Bioepis plans to market the drug under the name Ontruzant. In order to ensure a reliable supply of the trastuzumab treatment, the company plans to partner with multiple contracting organizations to carry out production of Ontruzant, a Samsung representative said.

Meanwhile, the biosimilar developer fended off rumors of a split with its marketing and distribution partner, MSD, in the Korean market. The Investor says that representatives from Samsung Bioepis today denied reports that a drug licensing agreement with MSD for Brenzys (a biosimilar etanercept, referenced on Enbrel) and Renflexis (a biosimilar infliximab, referenced on Remicade) had terminated after disappointing sales of the 2 biosimilars. According to The Investor, the cost savings provided by biosimilar therapies in the Korean marketplace typically do not exceed 10%, and have not produced rapid sales.

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