A Review of the Regulations on Interchangeability of Generic Medicines and Comparability of Biosimilars in the Philippines

Abstract

Background: The access to quality, safe, effective, and affordable medicines, such as generics and biosimilars remains to be one of the strategies of the Philippine government to achieve its health agenda, as seen in various legislations and policies. In order to ensure the interchangeability of generic medicines and comparability of biosimilars with their respective reference products, regulations to assure these characteristics have been implemented by the national regulatory authority.

Objectives: This narrative review aimed to compare the current regulations on interchangeability of generic medicines and comparability of biosimilars in the Philippines with those of selected international regulatory agencies and organizations, and identify research opportunities that can address some of the challenges in complying with these regulations.

Methods: Local regulations related to interchangeability and comparability were obtained from the official website of the Philippine Food and Drug Administration. Similarly, international regulations and guidelines which were selected based on a set of inclusion criteria were reviewed and compared with the local regulations. The internet search was conducted from 01-15 September 2017 and no statistical calculations or techniques were involved in the thematic content analyses.

Results and Discussion: The current regulation to ensure the interchangeability of generic medicines in the Philippines is based on the ASEAN and WHO Guidelines, and recognizes both in vivo and in vitro methods to demonstrate therapeutic equivalence. For the in vitro method, drug substances classified as BCS Class 1 and 3 are the only ones eligible for the biowaiver approach. For biosimilars, the Philippines adopted the WHO Guidelines which recognize comparability exercises as the approach to ensure the similarity of biosimilars with their respective reference products.

Conclusions: The current regulations on the interchangeability of generic medicines and comparability of biosimilars in the Philippines are aligned with those of international guidelines particularly of the World Health Organization (WHO). Research opportunities to address some of the identified challenges include permeability testing methods, development of biowaiver monographs, and practice research on biosimilars interchangeability, safety, and nomenclature.