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e Office of Generic Drugs within the FDA has recently published its 39 th product-specific guidance document on orally inhaled and nasal drug products (OINDPs), which includes requirements for a com- bination of in vitro and in vivo bioequivalence (BE) studies. Only in the case of nasal drug products has in vitro bioequivalence (BE) been accepted as stand- alone evidence. For dry powder inhalers (DPIs) and pressurized metered dose inhalers (pMDIs), evi- dence for bioequivalence must include in vitro BE, pharmacokinetic BE, comparative clinical end- points, formulation and device variables, and associ- ated patient factors. In addition, when clinical effects are regional (as with asthma and COPD medications), systemic pharmacokinetics can be difficult to interpret. An FDA Public Workshop was held on January 9, 2018, titled "New Insights for Product Develop- ment and Bioequivalence Assessments of Generic Orally Inhaled and Nasal Drug Products (OINDP)." It had the stated focus of "evaluation of these new methods for characterizing and demonstrating equivalence of OINDPs, including discussing the areas in which these methods may significantly con- tribute to generic product development and regula- tory understanding, how and under what conditions the methods should be conducted and evaluated, and inherent scientific challenges with this complex class of products." In theory, the primary advantages of the 505(b)(2) pathway are an accelerated and less costly development process that eliminates most non-clinical studies as well as extensive safety and efficacy tests. is decreased data and regulatory burden may yield the following results: • Lower developmental cost risks, due to the ability to use data generated by the originator product submission package; • Potentially lower product costs for patients and insurance companies; • Market exclusivity for up to three, five or seven years; • If a Phase III study is required for a 505(b)(2) appli- cation, such as when approval is sought for a pro- drug of a previously approved API, only one study is often necessary versus the two generally required for a 505(b)(1) application; • Fewer patients may be needed for 505(b)(2) product clinical trials, due to the existing large exposure infor- mation available in the public literature or FDA databases; • Overall time to approval is approximately 30 months. Regulatory considerations in development of 505(b)(2) OINDPs e FDA uses a variety of formats such as guidances, action plans and workshops to provide regulatory guid- ance for drug development, including its requirements for demonstrating bioequivalence. Inhalation December 2018 23 ATTEND • PRESENT • EXHIBIT • SPONSOR www.rddonline.com/rddeurope2019 RDD Europe is a conference jointly organized by MAY 7 - 10, 2019 Estoril (Lisbon), PORTUGAL Scientifi c Poster Abstract Submission Deadline: January 7, 2019