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Prestige and Pharmapark make deal for trastuzumab biosimilar Posted 09/08/2019

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Singapore-based Prestige BioPharma (Prestige) and Russia-based Pharmapark announced on 8 July 2019 that they had signed an exclusive partnership and supply agreement for Prestige’s candidate trastuzumab biosimilar (HD201) in Russia.

Trastuzumab is a monoclonal antibody that interferes with the human epidermal growth factor receptor 2 (HER2)/neu receptor. In some cancers, notably certain types of breast cancer, HER2 is overexpressed, and causes cancer cells to reproduce uncontrollably. Trastuzumab is therefore used to treat certain breast cancers.

According to the deal, Pharmapark will have exclusive rights to commercialize the trastuzumab biosimilar in Russia. Although the terms of the deal are not being disclosed, the companies say that Prestige will assume responsibility for product commercial supply out of its manufacturing facilities in Osong, Korea, while Pharmapark will be responsible for local registration, sales and marketing in Russia with the option to manufacture the product in Russia in line with the Russian import substitution strategy.

Prestige had the regulatory submission for its proposed trastuzumab biosimilar Tuznue (HD201) accepted by the European Medicines Agency in May 2019 [1]. Prestige also says that it intends to file its application for HD201 with the US Food and Drug Administration in 2019. Prestige also has a bevacizumab biosimilar (HD204) in phase III, an adalimumab biosimilar (PBP1502) in phase I and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer in preclinical stages.

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Positive phase III results for trastuzumab biosimilar HD201

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Trastuzumab biosimilar from Prestige accepted for review by EMA [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 9]. Available from: www.gabionline.net/Biosimilars/News/Trastuzumab-biosimilar-from-Prestige-accepted-for-review-by-EMA 

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Source: Prestige

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