The products are non-originator biologicals of rituximab (Acellbia) and trastuzumab (Herticad). The registration process was started in December 2018 and involved examination of documentary evidence on the drugs, as well as investigation of the quality of samples. This process, according to Biocad, led to the approval of the two drugs being granted by The Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina, which gives the company a five-year registration certificate for the two drugs.

Biocad is collaborating with ICM d.o.o, which will be responsible for distribution in Bosnia and Herzegovina, while Biocad will organize supplies of the drugs. The two hope to launch the products in Bosnia and Herzegovina, which they will do largely through individual contracts with state and private cancer centres, as early as June 2020.

This latest approval brings the company a step closer to its ambition of entering the European Union (EU) market. Biocad announced during the CPhI Worldwide exhibition in November 2019 that it intends to enter the EU market. The company intends to do with two of its innovator monoclonal antibodies – an interleukin-17 inhibitor (inn-netakimab) and a PD-1 inhibitor (inn-progolimab) [1].

The rituximab and trastuzumab market in Bosnia and Herzegovina are estimated to be worth around US$12.7 million.

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 non-originator biologicals approved in Bosnia and Herzegovina might not have been authorized if they had been subjected to the strict regulatory processes required for approval of biosimilars in the EU.

Related article
Non-originator biologicals approved in Russia

Reference
1. GaBI Online - Generics and Biosimilars Initiative. Biocad announces positive rituximab results and plans to enter EU market [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2020 Apr 10]. Available from: www.gabionline.net/Biosimilars/Research/Biocad-announces-positive-rituximab-results-and-plans-to-enter-EU-market

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