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Regulatory Focus™ > News Articles > 11 > New Product-Specific Guidances Focus on Drugs Without Generic Competition

New Product-Specific Guidances Focus on Drugs Without Generic Competition

Posted 28 November 2018 | By Michael Mezher 

New Product-Specific Guidances Focus on Drugs Without Generic Competition

The US Food and Drug Administration (FDA) on Tuesday issued 63 new and revised draft product-specific guidances detailing its expectations for companies looking to develop generic versions of those products.
Of the 63 guidances, 22 are new draft guidances and 41 are revised draft guidances. According to FDA Commissioner Scott Gottlieb, nearly 70% (43) of the guidances are for products that do not have any generic competition.
Some of the newly released draft guidances include product-specific recommendations for developing generic versions of Shire’s dry eye drug Xiidra (lifitegrast) and Merck’s type 2 diabetes drugs Steglatro (ertugliflozin), Steglujan (ertugliflozin and sitagliptin) and Segluromet (ertugliflozin and metformin HCI).
The latest batch of product-specific guidances also brings the total issued by the agency to more than 1,600 since it began releasing the guidances in 2007.
“By issuing recommendations on how to develop products that are therapeutically equivalent to these branded drugs, we’re making the process for copying these medicines more efficient and creating an easier path for generic alternatives to enter the market,” Gottlieb said, adding that these efforts have contributed to the record number of generic approvals seen in FY2018.
More than half of the guidances (four new and 31 revised) are for complex drugs, which have historically been a challenge for industry to develop generic versions of in lieu of specific guidance from FDA. Two-thirds (23) of those guidances are also for drugs that lack generic competition.
In a report last January, the Government Accountability Office called on FDA to publish its plans to reissue or revise product-specific guidances for complex drugs to make the development of such drugs more predictable for generic sponsors.
According to FDA, most of the revised draft guidances were updated to “include information on data standards formatting for clinical endpoint bioequivalence studies” for alignment with the Clinical Interchange Standards Consortium.
FDA, Federal Register Notice


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