Samsung Bioepis to supply Brenzys to Brazil under production development partnership

Biosimilars/News | Posted 27/09/2019 post-comment0 Post your comment

On 10 September 2019, Samsung Bioepis announced that it had signed a productive development partnership (PDP) with Brazil’s Ministry of Health to supply Brenzys, a similar biotherapeutic product to rheumatoid arthritis treatment Enbrel (etanercept), to Brazil for the next 10 years.

Samsung Bioepis Engineers V16K25LB R

Brazil’s PDP is a government programme aimed at reducing healthcare costs, in which a multinational biopharmaceutical company, a Brazilian pharmaceutical company, and a state-funded research institute enter into a partnership. Through this partnership, the multinational biopharmaceutical company transfers its production technology to the Brazilian pharmaceutical company and research institution for a specified time period [1].

Samsung Bioepis is the first Korean company to establish a PDP with Brazilian biopharmaceutical firm Bionovis and research institute BioManguinhos. Under the agreement, Samsung Bioepis will directly supply Brenzys to Brazil for the next 10 years and hand over its production technology to the local companies. For the following 10 years, Samsung Bioepis will receive a certain amount of royalties against sales of Brenzys.

‘The company has been recognized for its global R & D capabilities based on process innovation’, said Samsung Bioepis CEO Ko Han-sung. ‘We expect to expand the opportunities for high quality biopharmaceutical treatment in Brazil, which has the largest pharmaceutical market in Latin America’.

Other companies taking part in PDPs in Brazil include Merck Serono (etanercept, rituximab, trastuzumab), mAbxience (etanercept, rituximab, trastuzumab), Alteogen (etanercept, trastuzumab) and Biocad (rituximab, trastuzumab) [1]. Over 90% of autoimmune disease treatments in Brazil are supplied through the nation's PDP programme.

Samsung Bioepis received approval in Brazil in 2018 for its infliximab similar biotherapeutic product Renflexis, and in 2019 for its trastuzumab follow-on biological Ontruzant [2]. 

Editor’s comment
It should be noted that similar biotherapeutic products approved in Latin American countries might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the EU. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

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1. GaBI Online - Generics and Biosimilars Initiative. Producing follow-on biological products in Brazil []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 27]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Brazilian approval for trastuzumab follow-on biological Ontruzant []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Sep 27]. Available from:

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