Biocad’s rituximab ‘similar biologic’ recommended for approval in India

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Biocad’s rituximab ‘similar biologic’ recommended for approval in India

Biosimilares/Novedades | Posted 18/08/2017 0 Post your comment

Russian biotechnology company Biocad announced on 4 July 2017 that it would ‘soon’ receive marketing approval for its rituximab ‘similar biologic’ in India under the trade name Acellbia.

Biocad stated in its press announcement that the Central Drugs Standard Control Organization (CDSCO) recommended approval of Acellbia on 20 June 2017. The CDSCO is the national regulatory authority in India that evaluates safety, efficacy and quality of drugs in the country.

The approval was based on Acellbia having ‘demonstrated’ ‘similar efficacy and safety compared to the reference drug rituximab’, Roche’s MabThera/Rituxan (rituximab), ‘during international clinical trials, which were conducted in accordance with EMA guidelines for non-clinical and clinical development of biosimilars’.

According to Biocad, Acellbia will receive permanent market authorization in India in August 2017. The company expects its first shipments of the drug to take place in September 2017.

Biocad states that its rituximab product ‘has already been authorized in seven countries’ and ‘registration is pending in 27 countries’. The company received Russian approval for AcellBia (rituximab) in April 2014 [1] and Usmal (rituximab) was approved in approved in Bolivia and Honduras in June 2017 [2].

Acellbia is Biocad’s first ‘similar biologic’ to be approved in India, but it is not likely to be the last. The company plans to obtain a marketing authorization for Herticad, its trastuzumab product in the first quarter of 2018.

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References
1. GaBI Online - Generics and Biosimilars Initiative. Rituximab non-originator biological approved in Russia [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Aug 18]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-rituximab-approved-in-Russia
2. GaBI Online - Generics and Biosimilars Initiative. Biocad registers rituximab similar biotherapeutic product in Bolivia and Honduras [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Aug 18]. Available from: www.gabionline.net/Biosimilars/News/Biocad-registers-rituximab-similar-biotherapeutic-product-in-Bolivia-and-Honduras

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Source: Biocad