Between January and March 2019, Russia imported 165,000 units of pharmaceutical drugs for clinical trials (CT), worth 3.8 bln RUB (free circulation prices), which is in monetary terms (rubles) 1.8% lower and in physical terms 17% lower than that of the same period in 2018. Despite the negative dynamics, the total number of importing products has increased by 18, to 318.

Back to normal again, placebo drugs account for around 47% of the total import in physical terms. In 2018, placebo drugs accounted for only 39%. Since the prices of placebo drugs are nearly thrice as low as those of pharmaceutical drugs, placebo drugs in monetary terms account for only 22%. However, there is no direct correlation between the prices of placebo and pharmaceutical drugs. The shipment size and shipments period play a more significant role.

Between January and March 2019, Pemafibrate (K-877) by Kova Group (USA) accounted for the largest import volume of pharmaceuticals for CT, with 6,912 units imported in January alone. Kova Group is carrying out an international multicenter clinical trial (IMCT) involving 46 medical organizations from various Russian regions and 1,260 patients. Pemafibrate is followed by Bempedoic Acid Placebo (ETC-1002) by Esperion Therapeutics carrying out an even larger IMCT that involves 81 medical organizations and more than 1,600 patients.

Between January and March 2019, Russia started importing 34 new pharmaceutical drugs that had not been imported to Russia since 2013. Among these, Nitroglycerin (MED2005), topical gel for erectile dysfunction by Futura Medical Developments (Great Britain), accounts for the largest import volume in physical terms, with 2,128 units imported in February and March 2019. Nitroglycerin is followed by Luseogliflozin (TS-071, Lusefi) by Taisho Pharmaceutical (Japan), with 1,400 units; it is at the 3rd stage of CT, awaiting efficacy and safety evaluation as addition to Metformin for Caucasian patients with type 2 diabetes and lack of glycemic control.

Dynamics of pharmaceutical drug import volumes for clinical trials (CT) to Russia (2016 – 2018, Q1 2019), free circulation prices (customs duties and VAT included)