Co-sponsored with the FDA.

Complex Generic Drugs are a large and diverse group of products with complex active ingredients or sites of action and complex drug-device combination products. They provide important therapies to patients, for example, metered dose inhalers for treating asthma and drugs administered by auto-injectors and prefilled syringes. Because this diverse collection of drug products has one or more elements that are more complex than a simple dosage form, new complexities in the methodologies used for establishing bioequivalence are introduced, thus impeding patient access to the more affordable generic versions of these life-saving medicines.

In 2017, the FDA announced the Drug Competition Action Plan to advance new policies aimed at bringing more competition to the drug market to help reduce drug prices and improve consumer access to these much-needed medicines. The intent is to improve the efficiency of the generic drug approval process and make it easier to bring generic competition to this important category of branded drugs known as complex drugs.

Knowing that the scientific and regulatory pathways for approval of generic versions of complex products are not always well- known to generic developers, FDA intends through its policies to provide as much scientific and regulatory clarity as possible with respect to complex generic drugs. This meeting will address complex drug-device combination products, examining the science of medical device impact on drug bioequivalence in products where the drug is the primary mode of action (PMOA). The impact of devices such as auto injectors, prefilled syringes, inhalant devices, implanted delivery systems, transdermal systems, and others will be explored. The intersections of drug and device regulatory pathways and policies relating to bioequivalence studies will also be reviewed.

Join FDA staff from the CDER Office of Generic Drugs (OGD), the Office of Pharmaceutical Quality (OPQ), CDRH, the Office of Combination Products (OCP), and industry experts to discuss the knowns, unknowns, and the role of modeling in the development of these important products.

Exclusive Podcast

Take a listen to our podcast with Maryll Toufanian, Acting Director, US FDA Office of Generic Drug Policy. “In order for FDA to approve a generic drug, a generic manufacturer must submit scientific information supporting the generic drug’s ‘sameness’ to the brand.”

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Additional Resources - On-Demand Generics Webinar Series

• An Overview of Challenges and Opportunities in the Development of Complex Generic Drug Products
• Overcoming Barriers to Entry for Complex Generic Oral Inhalation Drug Products
• FDA Champions Research to Make Complex Generic Transdermal Products Available to Patients