Celltrion launches Truxima in Brazil

Biosimilars/News | Posted 17/07/2020 post-comment0 Post your comment

On 27 May 2020, South Korean biotechnology company Celltrion Healthcare (Celltrion) announced that it had launched its rituximab similar biotherapeutic product Truxima (CT‑P10) in Brazil.

Rituximab V13D29

Rituximab is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of immune system B cells. Rituximab destroys B cells and is therefore used to treat diseases that are characterized by excessive number of B cells, overactive B cells or dysfunctional B cells. This includes many lymphomas, leukaemias, transplant rejection and autoimmune disorders.

The launch of Truxima marks Celltrion’s third similar biotherapeutic product to be marketed in Brazil. The company also markets an infliximab similar biotherapeutic product called Remsima and a trastuzumab similar biotherapeutic product called Herzuma in the country, which is the largest market in Latin America.

Celltrion says that Truxima is the only rituximab similar biotherapeutic product released in Latin America that is also approved by both the US Food and Drug Administration (FDA) [1] and the European Medicines Agency (EMA) [2].

A Celltrion Healthcare official said that ‘Brazil is a key country that accounts for half of the Latin American market. It is expected that the launch of Truxima will have a positive impact on neighbouring countries, such as Chile and Ecuador’.

Celltrion, along with its partner, Israeli generics giant Teva Pharmaceutical Industries, launched Truxima in the US on 4 May 2020 [3].

Editor’s comment
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 but they are not universally accepted by regulatory bodies outside of the European Union (EU). It should be noted that similar biotherapeutic products approved in Brazil might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

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Similar biotherapeutic products approved and marketed in Latin America

1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-the-US
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Jul 17]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
3. GaBI Online - Generics and Biosimilars Initiative. Teva launches rituximab biosimilar Truxima in USInternational; [cited 2020 Jul 17]. Available from: www.gabionline.net/Biosimilars/News/Teva-launches-rituximab-biosimilar-Truxima-in-US

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Source: Celltrion

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