Third-Party Authorized Center for Biocomparability Studies

Biotechnology represents a promising alternative over chemically synthesized drugs for chronic and degenerative diseases, but as patents expited, biocomparables were developed. Before the regulatory framework for biocomparables was developed in Mexico, 65 products were registered as traditional generics by several companies, at a when quality and safety requirements were more lenient. Norm 257, issued in December 2014, requires characterization studies that demonstrate the safety and efficacy of all biocomparables as well as their similarity to reference products. This has resulted in a backlog of biocomparables awaiting evaluation for compliance with the new regulations. Failing to meet the required standards will result in product withdrawal from the market. This also means that public healthcare institutions that have been using biocomparables prior to the new regulations, that transpire to not meet the new requirements, will need to replace these drugs with their innovative versions at considerably higher prices.

The whole biotechnology industry is still developing worldwide but the global environment remains somewhat cautious about biocomparables. Approval timelines for regulatory processes are significant as Mexico competes with countries all over the world and rapid approvals are extremely important for the success of a new medication. Fortunately, timelines in Mexico are better than in other Latin American countries, according to Jose Luis Viramontes, Remote Site Management and Monitoring Director of PPD Latin America, but the process for biocomparables is more complicated than that for small molecules, and therefore slower. COFEPRIS will evaluate biocomparable drugs on a case-by-case basis and will publish a set of requirements for a specific product. Therefore, some products may need more studies than others and some companies will practically need to start from scratch if they want to stay in the game.

To make these decisions, COFEPRIS has implemented a strategy that is comparable to that of any advanced country and formed a Biotechnology Products Evaluation Subcommittee, managed by experts on the subject and which passes its decision onto the Committee of New Molecules, which in turn confers with the COFEPRIS. Moreover, it authorized third-party units to offer analytical characterization and pre-clinical studies, as well as clinical studies for biocomparables.

Although such third-party units have experts in the field, Sandra Sanchez y Oldenhage, Director General of Probiomed explains that there is no supplier in Mexico that can do the full characterization of biocomparable products therefore more investment is needed to support and develop the necessary infrastructure for local companies to meet regulatory requirements and ensure quality standards. This could ultimately push forward the local industry and increase the number of patients who benefit from high quality biocomparables at low costs.

AUTHORIZED THIRD-PARTY UNITS FOR ANALYTICAL CHARACTERIZATION AND PRE-CLINICAL STUDIES

BT

UNAM

UNIPREC

INMEGEN

CIATEJ

UDIBI

UANL

AUTHORIZED THIRD-PARTY UNITS FOR CLINICAL STUDIES

CECYPE

Accelerium

Bioemagno

IPharma

Laboratorio