By Rebecca Lynch
April 13th, 2021
This year, Global is excited to target a new growth area in generic drug submissions (ANDAs, or Abbreviated New Drug Applications). Our experts bring over 30 years in generics and 50+ original ANDAs, including a wide range of dosage forms.
Generic small-molecule drugs look likely to have a strong future as well; 70% of FDA’s new drug approvals in 2019 were small molecule entities, so many of these will be likely to have generic versions. FDA also maintains a list (updated twice yearly) of off-patent, off-exclusivity drugs without an approved generic. The current list shows over 250 drugs still awaiting generic development.
Generics are less expensive primarily because they don’t require preclinical (animal) and clinical (human) study data to establish safety and effectiveness. Instead, generics rely on sameness to an approved reference drug: the generic has to contain the same active ingredient(s) and it must deliver the same amount of active into the patient’s body at the same rate as the reference drug.
Since the introduction of Hatch-Waxman (The Drug Price Competition and Patent Term Restoration Act) in 1984, generics in the US have grown to fill about 90% of prescriptions, and FDA continues to look for innovations in the generic space, as demonstrated by recent establishment of the Competitive Generic Therapy (CGT) program and the new Center for Research on Complex Generics.
To date, 77 drugs have been approved under CGT. Eligible drugs (those with “inadequate generic competition,” or no more than one approved drug in the active section of the Orange Book) may be designated by FDA, or the applicant may submit a CGT request. If awarded, the program provides options for expedited development and review, as well as FDA meetings. When approved, the CGT designation grants the product an exclusivity period of 180 days.
FDA’s Center for Research on Complex Generics was established in partnership with the University of Maryland and the University of Michigan, and its aim is to enhance industry collaboration in complex generic development. A complex generic, currently defined under the GDUFA II Commitment Letter, has a complex API or formulation, or is a complex drug-device combination product such as an auto-injector or metered dose inhaler. The Center is currently offering a survey to help identify training and research activities that industry would like to focus on; it can be accessed at their website along with registration for their mailing list.
Global’s scientific and regulatory teams are ready to support your ANDA project, including every step from drug substance manufacturing through final product development, submission, and review.
Also, we’ve been 100% remote before social distance became a verb, so we’re already proficient in online platforms and set up for a fast start. We’d love to hear from you if you’re considering a generic project!
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