Brazilian approval for trastuzumab follow-on biological Herzuma (trastuzumab-pkrb) Posted 14/06/2019

South Korean biosimilars firm Celltrion announced on 23 May 2019 that the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) had approved its trastuzumab follow-on biological, Herzuma (trastuzumab-pkrb).

The registration of the cancer follow-on biological product was published in the country’s Official Gazette (Diário Oficial da União) on Monday 20 May 2019.

ANVISA has approved Herzuma in dosages of 150 and 440 mg for the same indications as the originator trastuzumab, Herceptin. This includes early-stage breast cancer, metastatic breast cancer and metastatic gastric cancer. According to Celltrion, Roche’s Herceptin has a market in Central and South America of KRW 300 billion.

Celltrion points out that the Brazilian Government’s heathcare system is burdened with the costs of importing 80% of the nation’s pharmaceuticals and spending 32% of its entire pharmaceutical budget on antibody pharmaceuticals. It therefore expects a favourable reception for its follow-on biological in Brazil ‘because 80% of the pharmaceuticals are sourced through tenders by the federal and the local governments’.

Celltrion gained Brazilian approval for its infliximab follow-on biological, Remsima, back in April 2015 [1] and the company is also expecting to receive approval in the near future for another follow-on biological, Truzima (rituximab). The company believes that ‘Truxima will effectively supplement Remsima (infliximab) and Herzuma in helping the firm secure a leading market position in the Central-South American biosimilar market’.

Celltrion has also received approval for Herzuma in Australia, Europe, Korea and the US [2].

Editor’s comment
It should be noted that follow-on biologicals approved in Brazil might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. 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. Brazil approves first monoclonal antibody follow-on biological []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 14]. Available from:
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of trastuzumab []. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Jun 14]. Available from:

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Source: Celltrion, Diário Oficial da União

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