Because of their complex mode of delivery, demonstrating bioequivalence of generics for inhaled products can be difficult. Mark Copley, Copley Scientific looks at the surrounding issues and at optimising in vitro testing for the development of generic inhaled products.
As the inhaled product industry matures, and blockbuster drug patents expire, opportunities for generics manufacture increase. Many companies are already capitalising on growing global requirements for effective, inexpensive treatments for chronic obstructive pulmonary disease (COPD) and asthma.
Over the longer term, systemic inhaled therapies, if successful, may become similarly ripe for generic activity. However, the performance of inhaled products, especially dry powder inhalers (DPIs), can be challenging to replicate. The application of appropriate in vitro techniques is crucial to ensure that relevant analytical information is efficiently gathered to support regulatory applications.
New regulatory guidance from the EMA1 provides comprehensive information regarding the issues that need to be addressed to demonstrate bioequivalence in a strictly generic product for European registration. For some, though, the inhaled drug delivery route is perceived as presenting opportunities for the development of so-called ‘supergenerics’ – products that use an approved active pharmaceutical ingredient but offer enhanced therapeutic efficiency. Such products may proceed to market via the FDA 505 (b)(2)2 approval route, in the case of the US, which although streamlined, offers exclusivity of cover for up to three years.3
Not yet a Subscriber?
This is a small extract of the full article which is available ONLY to premium content subscribers. Click below to get premium content on Manufacturing Chemist.
Subscribe now Already a subscriber? Sign in here.