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It has been a long held understanding within the pharmaceutical industry that the registration of inhaled pharmaceutical products has been somewhat challenging, especially with regard to generic filings. These issues have mainly centred around the quality section of the dossier and therapeutic equivalence. Recently, the European Medicines Agency (EMA) began a consultation on planned changes to its stance on the pharmaceutical quality of inhaled and nasal products. The EMA has published a concept paper to start bringing its guidance in line with changes in thinking about therapeutic equivalence since it released its current advice in 2006. This is a good move forward for the industry, and shows that the regulators are willing to adapt guidelines in light of industry feedback and experience.
Changes to the EMA’s position on therapeutic equivalence are the top priority for the concept paper on pharmaceutical quality. The EMA has published its concept paper in conjunction with another that deals specifically with how to show the therapeutic equivalence of inhaled treatments of asthma and chronic obstructive pulmonary disease. The second, therapeutic equivalence-focused concept paper is expected to usher in changes that affect the EMA’s position on pharmaceutical quality, forcing the regulator to update the two texts in parallel.
In the quality concept paper, officials at the EMA’s Quality Working Party outline the need to update the guideline to reflect changes to dose proportionality, flow-rate dependency, stage grouping and other topics. The EMA has derived these priorities from its work on the therapeutic equivalence concept paper. That concept paper marks the start of an attempt to adapt a 2009 guideline to reflect the experiences of applicants who have sought to show therapeutic equivalence to an orally inhaled reference product. National competent authorities have received several such filings since the guideline was last updated. The new guideline will describe a stepwise process to demonstrate equivalence that goes from in vitro studies, to pharmacokinetic tests and on to pharmacodynamic and clinical safety and efficacy trials. Recognising that showing therapeutic equivalence using in vitro and pharmacodynamic data is difficult, the EMA wants the guideline to reflect the relative benefits of pharmacokinetic studies.
The EMA is also using the updates of the two guidelines as an opportunity to address other issues. Topics up for discussion in the therapeutic equivalence text include advances in metered dose inhalers and dry powder inhalers. In addition to therapeutic equivalence, once it starts work on revising the quality guidance the agency plans to look at abbreviated methods for determining aerodynamic particle size distribution, tests of delivered dose uniformity, lifecycle management and other topics. The quality concept paper is open for comment until the end of June 2017. The EMA will close the comment period on the therapeutic equivalence text at the end of May.
At ELC Group we continuously stay abreast of all the current developments in regulatory thinking and are able to provide clients with insight and robust intelligence in the development and registration of their current and future product pipeline. Successful registration of inhaled products is just one of our key focus areas within our regulatory affairs division. We look forward to helping companies gain successful registrations on these and many other products.
