Report: US FDA guidance on complex generics to boost ANDAs in India

29-Oct-2018 - Last updated on 29-Oct-2018 at 16:17 GMT

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The FDA’s recent guidance on complex generics ‘increases clarity’ for Indian drugmakers targeting the US market, according to India Ratings and Research.

The US Food and Drug Administration (FDA) issued guidance documents designed to advance the development of generic transdermal and topical delivery systems on October 9, 2018.

According to the FDA, these drugs have complicated formulation or delivery systems, making them harder to ‘genericize’ under the agency’s traditional approaches. “As a result, these drugs often face less competition,” said FDA Commissioner Scott Gottlieb.

“The increased transparency and predictability provided by these [documents] and other product-specific recommendations gives applicants seeking to develop generic copies of these complex products a better opportunity to efficiently advance these products and prepare better and more complete submissions,” he added.

An India Ratings and Research (Ind-Ra) report, published last week, has since revealed that US drugmakers may not be the only firms to benefit from this latest guidance.

According to Ind-Ra’s analysis, the FDA’s recommendations can “reduce review cycles and expedite approvals” for Indian drugmakers looking to gain US market share. “Ind-Ra believes that select Indian pharmaceutical formulators with pending abbreviated new drug application (ANDA) approvals or development pipelines in these complex delivery systems would benefit from this development.”

Market opportunity

In the report, analysts predict opportunity for Indian drug formulators in the transdermal molecule space – which in the US “had a cumulative market size in the range of $3.5bn to $4bn at end-2017.”

Of the 19 molecules in the US transdermal market across pain management, cardiology, gynaecology, gastro-intestinal, neurology and anti-addition, five have expired patents and no generic competition, the report continued.

Concerning complex topical patches, three of the four molecules across dermatology and pain management therapies have patents due to expire in April 2019, June 2021, and August 2027. “These molecules had a market size of around $1.5bn at end-2018,” said Ind-Ra.

Building US presence

Current Indian players in the generic transdermal space include Lupin and Dr. Reddy’s Laboratories, with topical formulation ANDAs pending for companies including Cadila Healthcare, Cipla, and Glenmark Pharmaceuticals.

According to the report, Indian pharmaceutical formulators are also increasing investment in complex generics R&D, while simultaneously acquiring products and technology platforms to enhance their presence in this space.

“However, the ability of Indian formulators to complete/close the gap created by large established global peers in the complex generic space will remain critical,” according to Ind-Ra, adding that the Indian pharmaceutical industry is looking forward to “the receipt of similar guidance on scientific, regulatory and legal issues for other complex generics”.