Biopharmaceuticals in the Russian Federation: A snapshot of policies for registration, reimbursement and use

摘要

Global biopharmaceutical industry is entering a new area. The first biopharmaceuticals, released 20-25 years ago are out of patent protection already. The top selling biopharmaceuticals with a market volume of tens of billions of US dollars will be out of patent by 2010. And the process will go on and on. Transnational corporations are sounding alarm: by producing bio-generics new biotechnologies, mostly of India and China, threaten multibillion profits of Big Pharma, the phrase often used to refer to companies with revenue in excess of Dollars 3 billion, and/or R&D expenditure in excess of Dollars 500 million. The largest transnational companies launched huge PR campaigns against bio-generic producers under the cover of safety concerns for the public. Though there is a scientific basis for some concern due to the fact that bio-generics are not absolute copies of originator brands, and thus differ from chemical generics, patient safety care is definitely not the sole reason for their anxiety.