Colombian regulators’ ill-defined “alternative approach” to approving biosimilar medicines has the country’s patients unsettled. In a recent letter to the Ministry of Health and Social Protection, several Colombian patient organizations joined with the Global Alliance for Patient Access in emphasizing biological medicines’ complexity and the impact of immunogenic responses. Approving biosimilar medicines through anything other than a rigorous, data-driven process would be “highly troubling,” the signatories contend.
The Ministry of Health and Social Protection outlined the pathway for approval of biosimilar medicines used in Colombia in Decree 1782, signed by Colombian President Juan Manuel Santos Calderón in September 2014. Before the decree could go into effect, however, the ministry had to first issue guidance documents. One outlined biological medicines’ immunogenicity issues while another explored biological medicines’ stability. The Global Alliance for Patient Access’ letter addressed the former.
Signatories explain that they are “pleased” with the ministry’s references to standards from the Food and Drug Administration and the European Medicines Agency, “two drug regulatory agencies who have long considered matters regarding immunogenicity assessment of biological medicines.” Yet the signatories express concern about the document’s vaguely defined alternate approach to biosimilar approval, which could dilute an otherwise robust approval process:
The allowance of such an “alternative approach” is highly troubling given the inherent complexity of biological medicines and the impact to patient well-being resulting from adverse immune response. For Colombia’s physicians and patients to have confidence in biosimilar medicines, they must have assurance that these therapies were approved pursuant in a process that meets the highest of standards. Lack of confidence in the approval process will undermine the very goal of ensuring access to biosimilar medicines.
Twelve members from 10 Colombian patient organizations signed the letter on behalf of the Global Alliance for Patient Access.
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