Biologic data exclusivity in Vietnam: change is on the horizon

Several legislative changes affecting data exclusivity of biologic drugs in Vietnam are poised to come into effect, and companies operating in this sector should take note now, as Hien Thi Thu Vu and Huong Lan Nguyen of Tilleke & Gibbins explain.

Data exclusivity protection for biologics in Vietnam will soon undergo some welcome changes due to the enactment of a new pharmaceutical law at the beginning of 2017, and the country’s increased involvement in trade agreements such as the Trans-Pacific Partnership (TPP) and the EU-Vietnam Free Trade Agreement (EVFTA). While the changes are expected to be small, they could have a noticeable impact on manufacturers of biologics.

Biologics are composed of large, complex molecules, as opposed to the small molecules that make up conventional chemically derived drugs. Vietnamese legislation broadly defines biologics as medicinal products of biological origin used for the purposes of prophylaxis, therapy, and the diagnosis of human diseases. Biosimilars—the generic drug equivalent of biologics—also fall within this broad definition.

Clinical trials and data collection for conventional drugs and biologics are time-consuming and expensive to conduct, so it is necessary to offer, in addition to the protection provided by a patent, a period of data exclusivity protection to incentivise producers to continue research on new drugs.