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Generic approvals saved patients a whopping $10.7 billion in 2020 despite challenges posed by the pandemic, according to a new FDA report. And while there were fewer full approvals last year, that number may be on the rise, according to a former Office of Generic Drugs leader. Robert Pollock Former OGD acting deputy director Robert Pollock said in a recent blog post that the agency is likely to fully approve around 695 abbreviated NDAs this year and tentatively approve another 182. That’s slightly up from the 679 and 157 full and tentative approvals from last year, he wrote. “The process changes that FDA has made over the last three years or so, in GDUFA II and what’s proposed in GDUFA III, I think are really going to shorten the review times and cut down the number of review cycles,” Pollock told Endpoints News on Tuesday. GDUFA, or Generic Drug User Fee Amendments, were designed to speed up the generic approval process. However, Congress is still working on finalizing the reauthorization of FDA user fee programs for the next five years, with a deadline of the end of this month. Pollock served as acting director of OGD until 1994, when he left to join Lachman Consultant Services. He’s still with the consulting firm, in addition to holding the CSO spot at Melbourne Laboratories. “The thing that slows down generic drug approvals, I think, is directly related to the number of new applicants that come into the marketplace,” Pollock said. “People that aren’t familiar with OGD, what the requirements are.” He also recalls that OGD had a much smaller staff to work with than the NDA team. “I think that FDA has got to get to a point in generics where they’re operating more like the new drugs folks in terms of the amount of communications, and the access to the staff members that you see in new drugs,” he said. “The more communication between industry and FDA, the more value there will be to getting generic drugs out to the marketplace as soon as possible.” Full generic drug approvals totaled 754 back in 2020, resulting in about $10.7 billion in savings. That’s down from 836 full approvals in 2019, and $24.8 billion in savings, according to the FDA’s latest cost savings report. “Much of this year-to-year variation is due to the specific products for which generic equivalents are approved in each year,” the FDA noted. For example, 2019’s surge in savings was driven by a handful of high-dollar generics serving large populations, including generics to Viatris’ nerve and muscle pain drug Lyrica, which accounted for $6.6 billion of those savings. In 2018, generics accounted for roughly $17.8 billion in savings. When asked if savings are expected to rise this year, Pollock said it’s hard to say. Heidi Hunter “Historically, when the number of approvals increase, the savings increase,” he added. The news comes as biosimilars — copycat versions of biologics — are on track to reduce drug expenditures by $133 billion by 2025, according to a recent Cardinal Health report. “2022 is set to be a turning point in the U.S., as biosimilars expand into new therapeutic areas and sites of care, and reimbursement models continue to evolve,” Cardinal Health’s specialty solutions president Heidi Hunter said earlier this year. Last year was one of the 'most eventful in US biosimilars history,' but these analysts say 2022 should be 'a turning point'