Modified Regulatory Pathways to Approve Generic Drugs in the US and a Systematic Review of Their Outcomes

Abstract

Pharmaceutical manufacturers sometimes raise scientific concerns related to potential generic versions of their drugs; however, in the six cases we reviewed, these companies did not follow up the pre-approval concerns they raised with any methodologically rigorous post-approval testing using clinical endpoints. Despite their pre-approval controversy, experience with these generic drugs provides reassurance of their clinical interchangeability. Systematized post-approval study of certain generic drug bioequivalence determinations is needed.

Do patients trust the FDA?: a survey assessing how patients view the generic drug approval process

“…In such cases, regulators take a product‐specific approach to determining generic equivalence . These modified pathways can cause controversy, as some patients and physicians might worry that generic drugs approved using product‐specific bioequivalence standards have differential activity, although there is no evidence of variations in clinical outcomes …”

Generic drugs: benefit/risk ratio

“…Кроме того, на международном фармацевтическом рынке увеличивается число препаратов с уникальными фармакодинамическими характеристиками, требующими инновационных подходов к исследованию биоэквивалентности [31]. Примерами таких препаратов могут служить небиологические ЛС сложного химического строения (например, глатирамоиды, железо-сахарозные комплексы), а также отечественный препарат Мексидол ® (этилметилгидроксипиридина сукцинат), обладающий мультимодальным механизмом действия и разнообразными фармакологическими эффектами [32].…”