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Improving the pathway for generics approval in the US: 2019 update Posted 17/04/2020

The US Food and Drug Administration’s (FDA) Office of Generic Drugs released their 2019 annual report in February 2020. This gave updates on the number of generics approvals in 2019 which reached 1,014. It also gave information on the progress of FDA’s Drug Competition Action Plan (DCAP) and FDA’s Generic Drug User Fee Amendments (GDUFA) programme in 2019.

The DCAP and GDUFA programme are in place to improve upon efficiencies in generic drug development. They aim to make generic drug approval easier by addressing scientific and regulatory challenges that may arise. The FDA annual report highlighted that in 2019 with the aid of the DCAP and GDUFA funding, they began publishing new information to make it clearer for generic drug applicants to understand when they may be able to bring products that are under development to market. With this, and with improved transparency of data such as the dates of patent expirations and 180-day exclusivity decision status, it is hoped that applicants will be in a better position to make important business and timing decisions.

The report noted that FDA also continues to scientifically identify evidence that generic drug manufacturers need to support their applications prior to submission. This includes identifying the kind of study data required to demonstrate a drug will work in an equivalent way to the brand-name product. This kind of information is key in providing applicants with a clearer and more predictable path to approval.

It is hoped that the work done to aid pharmaceutical companies in their generics applications will reduce the number of complete response letters (CRLs) – or non-approvals – issued. This is because as, although there were many product approvals in 2019, there were also 2,311 CRLs. These letters ask for more information or request certain issues be resolved, after which the application may be reconsidered. The number of 2019 CRLs was down from the 2,648 issued in 2018.

Work was also done by the GDUFA regulatory science programme to ensure that the development, assessment and manufacture of generic drugs is based on modern, scientific standards. In 2019, the Office of Generic Drugs (OGD) issued 274 draft and final guidances (including 269 product-specific guidances), to provide clarity on regulation for generic drug development by providing companies with clear advice on how to appropriately generate the evidence needed to support approval. As medicines vary widely in their chemistry and in the manufacturing processes that are required to produce them, the OGD’s product-specific guidances now aim to provide recommendations to help manufacturers produce generic medicines that meet the required standards for comparison to a specific brand-name drug.

The 2019 approvals prioritized the review of generic drug applications for which there were no blocking patents or exclusivities or for which there was limited generics competition. The aim of this was to encourage the market presence of multiple FDA-approved generic drugs that will promote competition. Ideally, it is thought that there should be at least four approved applications for each product (including the brand drug). The report highlighted that the FDA data show that drug prices decrease significantly once there are at least three generic versions of a particular brand-name drug on the market. For example, the approval of generic Lyrica reduced the price of the drug from over US$7 per capsule of brand-name product, to approximately US$0.13 per capsule for the generic.

The report noted that in 2020, public health will remain of paramount importance for FDA. The OGD will seek to increase and strengthen interactions with industry, research community, lawmakers, patients, healthcare providers, and other stakeholders in the US and worldwide. They have also published their ‘Upcoming Product Specific Guidances for Complex Generic Drug Product Development’ online. This describes the 2020 plans for issuing new and revised Product Specific Guidances for complex drug products. The OGD hopes that, in sharing tools such as this and further enhancing the efficiency of generic drug application assessment, US citizens will have access to high quality, affordable generic drug products.

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Source: US FDA

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