US FDA to publish additional guidance to ‘genericize’ complex drugs
Complex drugs have difficult formulation and delivery systems, while the active pharmaceutical ingredients (APIs) needed for them are often harder to make into generics under traditional approaches. A number of complex drugs are no longer protected by patents that prevent generic approval but face no competition, according to the US Food and Drug Administration (FDA)
FDA announced plans to add to its policies in 2019 to promote generic competition to complex medicines once patents have lapsed.
In a statement, the agency said, “This focus is critical because, first and foremost, these drug products provide important therapies to patients. We believe that they’re also becoming increasingly important to the economic stability of the generic drug industry. Being able to ‘genericize’ a complex medicine can be a high-value opportunity for a generic drug developer.”
In 2017, the FDA issued its Drug Competition Action plan as part of the agency’s efforts to promote patient access to affordable medicines. Since the initiation of this plan, the FDA has released a list of off-patent brand drugs without generics, and established a new policy to expedite generic approvals.
The agency stated it intends to issue additional guidances towards developing specific complex generic drugs, and drugs that are difficult to produce generics for based on their formulation or mode of delivery.
Additionally, the FDA will issue draft guidance on complex generics, which will include recommendations on establishing API likeness.
The FDA will also work to advance the development of analytical tools and in vitro tests to support the approval of complex generic drugs that can also reduce the time and cost of drug development.
Additional steps the agency said it would be taking to promote access include: increased policies to ensure scientific and regulatory clarity, addressing challenges related to complex generics, and the promotion of generic competition.
Mylan’s complex generic approval
At the end of January, 2019, Mylan was granted approval for its Advair Diskus (fluticasone propionate and salmetrol inhalation powder) generic.
FDA deputy commissioner Anna Abram for policy, planning, legislation, and analysis acknowledged the approval of this complex generic by stating that the FDA is focused on aiding the approval of these complex generics.
