The DIA Complex Drug-Device Combination Workshop was held at Sheraton Silver Spring on October 9‑10, 2018. The second day’s discussion was dominated by issues related to transdermal systems and intrauterine devices. The presenters on the second day were mostly from the FDA, with a few from academia and CROs. The FDA presenters focused on quality expectations for devices, transdermal products, and research related to intrauterine devices, while the industry representatives talked about the challenges in developing therapeutically equivalent generics for these complex products.
Presentations related to some GDUFA-sponsored research regarding accelerated in vitro release for intrauterine devices and the important role of modeling and simulation in proposing new bioequivalence metrics for these products piqued interest. Developing generics for intrauterine devices has been considered especially challenging, considering that in-use periods for these products vary from three to five years, making requirements for bioequivalence and quality considerations complex. The information provided to the generic sponsors was considered valuable, but, with little settled at OGD and OPQ on these products, there is still a lot of work to do.
The final presentation summing up the conference provided some interesting statistics: about 61% of the NDAs for drug-device combinations are related to nasal/inhalation products; implants and injectors come next, each accounting for about 18%, and about 3% accounted for the “smart drugs.” It was indicated that the FDA is already working on understanding some of the new drug-device combinations approved as NDAs to outline what might be needed to support an ANDA filing. A few of the products mentioned in the presentations were Sinuva, Stiolto Respimat, Xhance, and Onzetra Xsail.
The Agency, academia, and industry acknowledged that development of complex generic products needs a significant amount of commitment from sponsors; the process may be time-consuming and expensive, and barriers in establishing “sameness” may be overwhelming at times. But then, we all know that a good design with a good intent makes a formidable “combination.” We are all eagerly waiting to see more FDA guidance and advice to support approval of generic combination products for the market in the near future.
