Chile’s Risky Biogeneric Regulatory Stance

The alleged positive economic externalities that biogenerics can trigger within healthcare systems, in the sense of lowering prices of very expensive therapies, seem quite alluring and widespread nowadays for several Governments that are facing staggering deficits in their budgets.

However, follow-on biologics should not be regulated for their market approval in the same manner than ordinary generic chemical drugs. For the generic pharmaceutical industry it is not always mandatory to file preclinical and clinical studies in order to evaluate and compare the efficacy and safety of their drugs against those registered previously by innovators, as well as claim interchangeability in connection to the same.

Moreover, the preclinical and clinical data requirements play a key role when it comes to ensuring the safety and efficacy of biogenerics, and thus entail a very sound and relevant safeguard for public health standards once these products are launched into the market.

Unfortunately, Chile lacks specific registration regulations for Biogenerics so the Public Health Authority (Instituto de Salud Pública – ISP) must resort to general provisions from Supreme Decree 1876/95 that list the necessary requirements to issue a sanitary registration or marketing approval for common chemical drugs but not for follow-on biological drugs.

In spite of this regulatory void, 174 biogeneric sanitary registrations have already been issued by ISP. The lack of biogeneric interchangeability coupled with the technical inability of generic manufacturers to fully elucidate the same manufacturing process that innovative biotechnological pharmaceutical companies follow in order to produce safe and effective biological drugs involves a risk for the health of Chilean patients that ISP seems to be disregarding.

Biogenerics differ from biotech drugs in the sense that they hold a different chemical compositions and are manufactured in a different manner. Hence, the interchangeability of biogenrics should be accepted only based on new clinical data that is exclusively submitted by the biogeneric manufacturer not the innovator.

Chile’s regulatory Stance is clearly risky and must be reformed in order to comply with regulatory standards that have been incorporated by the main Public Health Authorities in the world, such as FDA or EMEA.