Row Erupts Over “Third Way” For Biosimilar Approvals In Colombia

Colombia’s health ministry and the international R&D-based pharmaceutical industry association, Afidro, are at loggerheads over legislation that gives biosimilars a faster route to market. Afidro has requested that a decree be suspended, claiming that it will lead to the approval of medicines that have not been properly tested. Meanwhile, the health ministry has accused the association of creating overly onerous barriers to competition.

The legislation in question is Decree 1782 of 2014, which seeks to establish the procedures and requirements for evaluating and registering biological medicines. It sets out three possible pathways for a biological drug, all of which require the applicant to provide certain information including immunogenicity tests.

The first (Article seven) sets out the “complete dossier route.” This requires the applicant to present preclinical and clinical studies showing the product’s quality, safety and efficacy. The “comparability pathway,” set out in Article eight of the decree, requires the applicant to present the results of comparability studies between the drug under evaluation and the reference product. These routes to approval are similar to pathways in the US and EU for biologics and biosimilars.

Article nine lays out the controversial “abbreviated comparability route” i.e., for the approval of biosimilar versions of originator drugs. This exempts the manufacturer from, or reduces its obligations to present (except for immunogenicity tests), complete clinical studies, including comparative studies. In addition, it is not necessary for the reference product to be approved in Colombia, although it must be approved in another jurisdiction.

The aim of Article 9 is to “improve the availability of quality medicines, avoid unnecessary barriers to entry, broaden therapeutic options and generate savings in health spending,” says the health ministry.

The decree finally came into force in August this year after several setbacks, but it may yet be stopped in its tracks. In January, Afidro filed a complaint with the Council of State (Colombia’s highest court, presiding over administrative issues) demanding that the decree be suspended. The association claims that the third route to approval is not safe and does not conform to international standards. In September, the Council of State finally allowed Afidro’s application and officially notified the health ministry.

“Multinationals that ask for the law to be suspended are not thinking of the health of patients, but of maintaining their monopoly” – Colombia’s health ministry

In response, the health ministry has submitted a 17-page defense of the decree and has accused Afidro of self-serving interests. “Multinationals that ask for the law to be suspended are not thinking of the health of patients, but of maintaining their monopoly,” it said in a statement. It argues that resistance to the new rules stems from “strictly commercial interests, not concerns for public health and the safety of the Colombian people.” Suspending the decree would put lives at risk, according to the ministry.

It says that because the active ingredients in the reference products are widely known, the new rules mean that competitors do not have to present a complete set of human or animal studies, except for immunogenicity tests to demonstrate the product does not produce severe immunological responses.

However, the ministry emphasizes that, in order to guarantee quality, the decree does require that the active ingredient is sufficiently characterized, that it has a well-defined and documented safety and efficacy profile, that it has been used clinically, and that robust pharmacovigilance information is made available.

The health ministry is requesting that the Council of State consider ethical standards which, in line with the Helsinki Declaration, require that experiments on humans “should not be repeated to demonstrate things that have already been demonstrated.”

Industry Replies

Meanwhile, in a counter-statement, Afidro claims that there is already vigorous competition between high quality biologics and says the “hyper-abbreviated” route to authorization for certain biologics does not conform with international standards. It denies accusations that it opposes the entry of biosimilars that will compete with the originators.

“What we cannot accept is the existence of the so-called “third way” which allows an applicant to use the molecule of a third party, not its own, without doing clinical comparative studies. As no biologic is exactly the same as another one, the new manufacturer should at least demonstrate that its own manufacturing process, no matter how similar to that of the originator, does not hurt patients.”