USFDA approvals hit record high this year
Indian firms account for 35-40% of global nods
The US Food and Drug Administration (USFDA) has granted the highest number of drug approvals in its history this year. The regulator has bettered the last year’s numbers with 971 approval actions this year, which include 781 final nods and 190 tentative go-aheads.
Indian firms account for 35-40 per cent of the global nods. Analysts feel that the rising rate of approvals will increase competition in the US generic market, besides allowing the entry of new players. However, analysts expect 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 follow san October-September calendar. Of the total approval sin FY18, around 12 per cent were for complex generics and 95 for first-time generics. In FY17, the number of products approved stood at 937, of which 763 were final approvals.
The approval rate by the USFDA has been rising for the past few years. This is primarily because in 2012, the Generic Drug User Fee Amendments (GDUFA) 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 per cent of the abbreviated new drug application (ANDA) submissions within 10 months. Compared to this, in the cohort-four phase, it had to act on 75 per cent 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 the ANDA filing rate saw a significant jump from 539 in FY15 and 852 in FY16 to 1,306 in FY17.
However, this was down to 1,044 in FY18 and should now normalise. “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 that have significant exposure to the US market like Aurobindo, Sun Pharma and Cadila Healthcare. “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 the 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).