Russian Pharmaceutical Company gets Certification in Bosnia and Herzegovina for Two Medicines


On March 30, 2020, Russian pharmaceutical company, Biocad, announced that it and its partner, ICM d.o.o., recently obtained European registration certification in Bosnia and Herzegovina for two cancer treatment biosimilars:  Acellbia (rituximab), a biosimilar of Roche’s MabThera®, and Herticad (trastuzumab), a biosimilar of Roche’s Herceptin®.  According to Biocad, the registration certificate is valid for five years and initial deliveries are slated to start in June 2020.  Biocad further stated that ICM d.o.o. estimates that the market for these drugs in Bosnia and Herzegovina is $12.7 million.  Biocad’s chief executive, Dmitry Morozov, says the partnership next plans to seek registration in Serbia.

Relatedly, last year the Second Circuit denied Biocad’s Sherman Act antitrust claims against defendants Roche and Genentech for alleged anticompetitive conduct in Russia relating to these biosimilars.  The court found that the Foreign Trade Antitrust Improvements Act of 1982 barred any United States claim because the alleged conduct only resulted in foreign injury and shared no nexus with imports into the United States.

According to the latest data by ICM d.o.o., the market capacity of rituximab and trastuzumab in the country is estimated around $12.7 million. The sales of Russian drugs can start already in June, allowing to decrease government costs for anti-cancer treatment. “By analyzing international markets for launching drugs, we see that our products are in demand,” said Dmitry Morozov, CEO of BIOCAD. “Therefore, in parallel, we conduct registration processes in different countries of Europe. For example, after successful registration in Bosnia and Herzegovina, we are planning to gain access to the Serbian market. These are important steps towards one of the key objectives of our company: to make high-quality therapy available around the world”.


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