FDA issues guidance on generic versions of complex drugs


The US Food and Drug Administration (FDA) has released guidance intended to advance the development of generic versions of complex medical drugs.

Scott Gottlieb, commissioner of the FDA, announced the plans on Tuesday, October 9. It follows guidelines, released last week, which are hoped to prevent delayed generic approval of branded products.

This week, the development of generic transdermal and topical delivery systems (TDS) is the central focus of the FDA’s guidance.

Transdermal and TDS products are delivered by application into and through the skin.

“This includes inhaled drugs that act directly on the lungs, a topical patch that acts directly on the skin, or an eye drop that acts on the surface of the eye,” Gottlieb explained.

They must deliver the correct medication dose consistently and for a particular length of time, as well as adhering consistently and uniformly to the skin regardless of variables such as water and movement.

They are classified as complex drugs as a result of their delivery system, which makes them harder to “genericise” under traditional approaches, Gottlieb explained.

“In too many cases, there is no generic competition for these costly branded drugs even after they have lost their exclusivity protections,” Gottlieb said. “As a result, these drugs often face less competition.”

The FDA has released 25 product-specific guidance documents (two new ones and twenty-three revised ones). These are intended to support the industry in attempts to identify appropriate methods and evidence when developing generic TDS products.

In addition, the agency has released revised guidance on two particular areas of TDS generics.

In the first area, the document called “Assessing Adhesion with Transdermal and TDS for Abbreviated New Drug Applications (ANDA)” offers advice on the design and conduct of studies related to the adhesive performance of proposed generic TDS products.

The second document, “Assessing the Irritation and Sensitization Potential of Transdermal and TDS for ANDAs”, provides guidance on the same but in relation to the in vivo skin irritation and sensitisation potential of a proposed product.

Gottlieb said that the product-specific recommendations released by the FDA will give generic manufacturers a better opportunity to efficiently advance transdermal and TDS products, and in turn “prepare better and more complete submissions”.

The FDA explained that it has made a new commitment to developing product-specific guidance documents relating to generic drug applications, to allow for a more efficient and effective framework.

Over the coming months, the FDA will issue “umbrella guidance” followed by “targeted guidance” to address the legal and regulatory hurdles that may be blocking generic competition.

The agency has also committed to clarifying its policies on how the FDA evaluates differences in the instructions relating to the use of complex drugs, such as a drug delivery system.

It follows the launch of Gottlieb’s plan to enhance biosimilar competition, announced in July.

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US Food and Drug Administration, Scott Gottlieb, complex drugs, generic competition, Abbreviated New Drug Application, topical delivery systems



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