The US Food and Drug Administration (USFDA) has granted the highest number of drug approvals in its history this year. The regulator has bettered last year’s numbers with 971 approval actions this year. This includes 781 final nods and 190 tentative go-ahead. Indian firms account for 35-40 percent of the global nods. Analysts feel that rising rate of approvals would on one hand increase competition in the US generic market, and on the other allow new players to enter. However, analysts expect the growth in approvals to flatten as the number of filings has seen a dip in FY18. This is not expected to rise substantially in the coming years. The USFDA follows an October-September calendar. Of the total approvals in FY18, around 12 percent were for complex generics and 95 for first time generics. In FY17, the number of products approved were 937, of which 763 were final approvals.
The approval rate by USFDA has been rising for the past few years. This is primarily because in 2012, the Generic Drug User Fee Amendments (GDUFAs) were implemented to expedite the process of approvals. In 2016, the GDUFA entered its cohort-five phase, in which the FDA has to act on 90 percent of the abbreviated new drug applications (ANDA) submissions within 10 months. Compared to this, in the cohort-four phase, it had to act on 75 percent of ANDAs submitted within 15 months. The number of final ANDA approvals had increased from 651 in FY16, to 763 in FY17, and the trend was expected to continue. “However, this just saw a marginal increase and stood at 781 for FY18. We believe that the ANDA approval rate is likely to flatten,” said Amey Chalke, analyst with HDFC Securities. He added that ANDA filing rate saw a significant jump from 539 in FY15 and 852 in FY16, to 1306 in FY17. However, this was down to 1044 in FY18 and should now normalize. “We do not expect the number to rise substantially in the coming years,” Chalke said.
Interestingly, the ANDA withdrawal count of 548 saw a major spike in FY18, more than double its FY17 number of 214. Chalke said, “Evident from this data, competitive intensity in the US generics market is reducing. We believe this will also lead to easing of pricing pressure.” This can be a good sign for established drug firms who have significant exposure to the US market like Aurobindo, Sun Pharma and Cadila Healthcare, among others. “With rising approvals, the competition ate into our margins in the last couple of years. There was price erosion in the base business,” said a senior executive of a leading pharma firm. More approvals would mean entry of new players and this would intensify the competition. “However, with ANDA withdrawals on the rise, it may ease the pricing pressure to some extent,” he added. Of the Indian firms, Aurobindo and Cadila Healthcare received the maximum number of approvals in FY18 at 63 and 59, respectively (including tentative approvals). Of the global firms, Mylan received nod for 62 products in the US market. – Business Standard