While the FDA will not approve biosimilar applications for Eculizumab before 16 March 2019, there is an ongoing debate over the length of exclusivity periods. National regulators protect orphan drug producers from competition with biosimilar products through a multi-year exclusivity period, it is challenged as markets open and international trade deals are negotiated —such as the Trans-Pacific Partnership (TPP).  A generic version, branded "Elizaria'", is available in Russia.

In February 2015, Canada’s drug-price regulator took the rare step of calling a hearing into Soliris, accusing Alexion of exceeding the permissible price cap under the ""Highest International Price Comparison"" (HIPC). In June 2015, the Patented Medicine Prices Review Board (PMPRB) under the Canadian Patent Act, held a preliminary hearing in Ottawa, Ontario to examine allegations. John Haslam, President and General Manager of Vaughan, Ontario-based Alexion Canada, was named as one of the respondents. Alexion charges Canada $700,000 per person per year, more than anywhere else in the world. Alexion denies the claim. In Canada "provincial drug plans have already negotiated secret discounts on Soliris for many of the patients they cover."

As of 2015, while Eculizumab in PNH was associated with 1.13 additional life years and 2.45 quality of life years QALYs, there has been a high incremental cost (CAN$5.24 million) and a substantial opportunity cost. A 2014 Canadian study calculated the cost per life-year-gained with treatment as CAN$4.62 million (US$4,571,564) and cost per quality-adjusted-life-year as CAN$2.13 million (US$2,112,398)."The incremental cost per life year and per QALY gained is CAN$4.62 million and CAN$2.13 million, respectively. Based on established thresholds, the opportunity cost of funding eculizumab is 102.3 discounted QALYs per patient funded."

By 2015, industry analysts and academic researchers agreed that the high price of orphan drugs, such as eculizumab, was not related to research, development, and manufacturing costs: their price is arbitrary and they have become more profitable than traditional medicines. Sachdev Sidhu, a University of Toronto scientist, who spent ten years at Genentech before academia, estimated that public science was responsible for well over 80% of the work. "Public resources went into understanding the molecular basis of the disease, public resources went into the technology to make antibodies and finally, Alexion, to their credit, kind of picked up the pieces." The cost of manufacturing Soliris' monoclonal antibodies is less than "1 percent of the price of the drug," he said.

Brazil's supreme court had decided in April 2018 to break the patent of Soliris in Brazil following local law. This medicine was only provided by the government's health system (SUS) and now it can be produced by other companies in that country

With Regards,
Nancy Ella
Managing Editor
Drug Designing: Open Access