MOSL: HEALTHCARE-Brace for faster approval and more competition

​HEALTHCARE: Brace for faster approval and more competition; Guidance document focuses on expediting approval and launch process

• ​Multiple review cycles required to obtain ANDA approval by the USFDA has been one of the key concerns in the pharmaceutical industry as it delays the approval process. More than 80% of the pending ANDAs have been issued at least one review communication by the USFDA. Notably, around 1,800 ANDA applications are back with the industry, awaiting resubmission to correct deficiencies in the original ANDA filings. According to the USFDA, it takes around four review cycles to approve an ANDA due to the deficiencies by the generic drug sponsors. In the first week of Oct-17, the USFDA issued four guidance documents to provide further visibility on the ANDA filing and approval process.
  
• Guidance on amendments to ANDAs under GADUFA II: The USFDA recently issued a draft guidance document explaining how the review goals established as part of GDUFA II apply to amendments to ANDAs and Patient Administration Systems (PAS). The guidance explains that how the amendment submission may affect the review goal dates. Under GDUFA I, amendments were classified into a complex tier system. Although GDUFA II still depends on several common factors (similar to GDUFA I), it will no longer subject them to a tier system. The FDA has categorically mentioned in this recommendation that it will respond to 90% of the minor amendments to the ANDAs within three months of the submission date, while major amendments may take 6-10 months.
  
• Draft guidance to make complex generics approval process more efficient: The USFDA issued a guidance document describing an enhanced pathway for discussion between the USFDA and the complex generic filer through product development meetings (pre- and post-filing). Due to the challenging requirements for complex generic products, cost of development and approval timelines become a deterrent for prospective generic filers. Notably, in the plain oral segment, generic penetration has reached ~80%, while in the complex areas like derma, inhalations and long-acting injectable, generic penetration is only 10-40%. This guidance document outlines goals and criteria for accepting product development, pre-submission and mid-review-cycle meetings.