BIO appreciates this fourth opportunity to formally respond to the Colombian Ministry of Health’s Draft Decree on Regulatory Requirements for the Registry of Medicines of Biological Origin and we refer you to our previous comments filed to the Colombian Ministry of Health on April 24th 2012 (English PDF), June 12th 2012 (English PDF) and February 21st 2013 (English PDF) (Spanish PDF) for background about BIO and its interest in this Decree. These comments respond to the fourth draft of the proposed Decree, notified to the World Trade Organization’s (WTO) Committee on Technical Barriers to Trade on July 19th, 2013 (G/TBT/N/COL/196).
BIO commends the government of Colombia for taking steps towards developing regulatory requirements for the registry of medicines of biological origin. BIO and its members have participated actively in the public consultations and have engaged extensively with the Ministry of Health and their technical experts. While BIO applauds the Ministry of Health for proposing distinct pathways to market for both innovator biologics and biosimilars, BIO and its members have serious concerns with an additional proposed “Abbreviated Pathway” as a route for approval of a biosimilar product. Specifically, we are concerned that, as drafted, the proposed Abbreviated Pathway is not scientifically supported and may put patients at risk. It is BIO’s firm position that the inclusion within the 4th draft regulation published by the Colombian government, and notified to the WTO, of an Abbreviated Pathway fails to meet such standards and is inconsistent with WHO Guidelines on Evaluation of SBPs, thus raising substantial concerns with the safety of products that could be approved under such a pathway.
Please find the full WTO submission below.