Home / Pharma News / Richter and DM Bio make deal for trastuzumab biosimilar

Richter and DM Bio make deal for trastuzumab biosimilar Posted 11/11/2016

Hungary-based Gedeon Richter (Richter) announced on 19 October 2016 that it had signed a technology transfer and in-licensing agreement with South Korea-based biologicals specialist DM Bio for the development and commercialization of DM Bio’s trastuzumab biosimilar.

DM Bio is a joint venture formed by Dong-A Socio Holdings of Korea and Meiji Seika Pharma of Japan. It was officially launched in April 2015, began production in May 2015 and received manufacturing business approval from the Korean Ministry of Food and Drug Safety (MFDS) in September 2015.

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.

Richter will receive exclusive distribution rights for Europe, the Commonwealth of Independent States (CIS) region and Latin American countries and also obtains the pilot technology for further development.

Richter will make an upfront payment upon signature of the contract and further milestone payments depending on the progress of the technology transfer and clinical programme of the product. In addition, further sales-related royalties will become payable to DM Bio subsequent to the launch of the product.

Richter said the conclusion of the development and the start of the registration process could be expected in 2020−2021. The originator product, Roche’s Herceptin (trastuzumab), had 2015 worldwide sales of CHF 6.5 billion (US$6.6 billion).

The company announced in December 2015, that the European Medicines Agency (EMA) had accepted its regulatory submission for its proposed biosimilar to Amgen’s Neulasta (pegfilgrastim). Richter has reportedly also signed a licensing and distribution agreement for the product earlier in 2016 with Stada Arzneimittel (Stada). While in January 2016, Richter also announced that EMA had accepted its regulatory submission for the proposed biosimilar to Eli Lilly’s Forteo (teriparatide). 

Richter also made a deal with German generics giant Stada back in August 2011 to collaborate on the development and marketing of rituximab and trastuzumab biosimilars [1].

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1. GaBI Online - Generics and Biosimilars Initiative. Stada and Richter to collaborate on biosimilar development [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Nov 11]. Available from: www.gabionline.net/Biosimilars/News/Stada-and-Richter-to-collaborate-on-biosimilar-development

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Source: Gedeon Richter, Portfolio.hu

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