Two Russian cancer biosimilars receive registration certificate in Europe

Two products from Russia’s Biocad, Acellbia (INN: rituximab) and Herticad (INN: trastuzumab), have received the first European registration certificate in Bosnia and Herzegovina. Registration was received with the support of ICM d.o.o partner and is valid for five years. The first deliveries shall start in June 2020.

A biosimilar of Swiss pharma giant Roche’s (ROG: SIX) MabThera, Acellbia was approved in Russia in 2014, while Herticad, a biosimilar of Roche’s Herceptin, gained approval on the domestic market in 2016.

Registration processes started in December 2018. During this time, a thorough examination of the drugs documentary and samples quality was carried out.

Now Biocad is organizing the supplies, while ICM d.o.o is be responsible for distribution in Bosnia and Herzegovina, which is planned to be carried out mainly through state tenders and major sales to cancer centers. The sales launch and pricing largely depend on tenders, however, upon agreement with the partner, deliveries will start this year.