The company announced on 11 February 2019 that it had started comparative studies of the effectiveness of the originator biological Soliris (eculizumab) and its eculizumab non-originator biological in patients with paroxysmal nocturnal haemoglobinuria. The news follows approval of the clinical investigation from the Russian Ministry of Health (MoH) and signifies a move into ultra-rare diseases for Biocad.

Solaris is reportedly the most expensive orphan drug in Russia. The Russian MoH spent in 2018 Rubles 999.7 million and in 2019 it plans to spend on the purchase of the drug Rubles 2 billion.

The company also announced in March 2019 that it had registered its adalimumab non-originator biological in Russia.

The trials of the drug, according to Biocad, ‘fully confirmed the equivalence’ of the Russian non-originator biological with the originator biological Humira (adalimumab). By Week 16 of the treatment, Psoriasis Area and Severity Index (PASI) 75 was achieved in 62.5% of patients in the group treated with BCD-057; and, in the group treated with the original drug, this figure was 66.5%. The absence of differences compared to the original drug was also demonstrated for other characteristics of the disease (sPGA, BSA, itch, HRQL); both drugs have equivalent safety profile.

Biocad said that it has been actively developing BCD-057 for the last six years. It added that the ‘successfully completion of the main stage of phase III registration clinical trials [was] the last step in the development of [the] medicinal product before its registration and market launch’.

The company also said that the non-originator biological ‘was developed in full compliance not only with the Russian laws, but also with the main international recommendations for the studies in the area of biosimilar monoclonal antibodies’.

However, although approximately 50 non-originator biologicals (including monoclonal antibodies) have been approved in Russia to date, the country has not yet established clear regulatory guidelines for such products. Some have been authorized under an approach similar to the one used for small-molecule generics, and some following comparative clinical trials versus their reference products. Furthermore, some products have entered the Russian market with only limited clinical data available (one filgrastim biosimilar, for example, was approved on the basis of two small studies in a total of 51 patients).

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