Regulatory aspects and quality controls of polymer-based parenteral long-acting drug products: the challenge of approving copies

Abstract

To assure the safety and the efficacy of a medicinal product, quality and batch-to-batch reproducibility need to be guaranteed. In the case of parenteral long-acting products, the European Union (EU) and US Regulatory Authorities provide different indications, from the classification to the in vitro release assays related to such products. Despite their relevance, there are few in vitro experimental set-ups enabling researchers to discriminate among products with different in vivo behaviors. Consequently, most copies are authorized through hybrid instead of generic applications. Here, we review the actual regulatory frameworks to evaluate the in vitro release of drugs from polymer-based long-acting parenterals to highlight the directions followed by the Regulatory Agencies in the USA and EU.