While over the past five years, ANDA (abbreviated new drug application) approvals have slowly increased, the industry has observed a spike within the past two years. Each year the approval rate reaches a record level, and 2018 is no different - with generics continuing to lead the pack.
According to the US Food and Drug Administration (FDA), for a generic ANDA to be approved, the drug must meet specific criteria including: same active ingredient as the brand-name drug, the drug must be the same strength, same type of product and same route of administration, same use indications, and the inactive ingredients of the medicine are acceptable.
Nine out of 10 prescriptions in the US are filled for generic drugs, according to the FDA – increasing the availability of generic drugs creates competition in the marketplace, which helps to make treatment more affordable.
Generic ANDA approvals
Recently, the US FDA issued a draft guidance system to prevent branded firms from impeding the generic approval system. The draft guidance ensures the same approval time frame for generic drug assessment as a way to prevent branded firms from purposely delaying generic drug approvals.
An extra $473m (€415.6m) of funding in the US 2019 budget request was allocated to the US FDA. According to The Alliance for a Stronger FDA, this increase in fund allocation gives the ability for the FDA to bring generics to the market faster by incentivizing more competition among manufacturers.
Additionally, larger pharma companies like Novartis have been divesting generic units, making manufacturers like Aurobindo the second largest generics manufacturer in the US with an increased revenue following ANDA approvals.
