Woodcock Upbeat on Generic/Biosimilar Programs
FDA acting commissioner Janet Woodcock says there continues to be enormous opportunities for growth in the generic and biosimilar space. Addressing the virtual Association for Accessible Medicines generics and biosimilars conference 11/8, Woodcock said the agency’s goal is to “apply cutting edge science and maximize scientific and regulatory clarity to support industry in the development of alternative approaches for demonstrating bioequivalence.”
She said CDER’s Office of Generic Drugs has prioritized its work being done around complex generic drugs. “As you know, these drugs are critical to the treatment of multiple medical conditions, and, because they can be more scientifically challenging, time consuming, and expensive to develop, often lack adequate generic competition,” Woodcock said.
Earlier this year, CDER Office of Generic Drugs (OGD) Office of Research and Standards director Robert Lionberger outlined many steps OGD has taken to encourage the development of complex generic drugs that have complex active ingredients, dosage forms, routes of administration, or drug-device combinations). He said the agency has approved more than 100 complex generic drugs each year since 2018 and each month new complex generic options become available to patients in need.
“Ensuring transparency and clarity during the assessment process, publishing guidance documents based on the latest science, and conducting and publishing scientific research help drive complex generic product approvals that meet our high scientific standards,” Lionberger said. “We know the promise and potential of complex generics, and we intend to focus our regulatory and scientific initiatives to expand and strengthen this important area of our nation’s public health system.”
Woodcock’s presentation also covered some top-level numbers reflective of the generic and biosimilar industries. Last year, Americans saved $338 billion by using generics and biosimilars, she said, an increase of $18 billion from 2019. Generics make up about 90% of all prescription drugs dispensed in the U.S., but only 18% of all prescription drug spending. “In FY 2021, for instance, we approved or tentatively approved 836 abbreviated new drug applications, including 679 final approvals and more than 90 first generics,” she said.
Regarding biosimilars, “new launches and improved utilization led biosimilar savings last year to grow by more than three times the $2.5 billion saved in 2019, with an especially high impact in oncology,” Woodcock told the conference. Overall, FDA has approved 31 biosimilars for 11 different reference products. Currently, there are 94 programs enrolled in the agency’s Biosimilar Product Development Program, and CDER has received meeting requests to discuss biosimilar development for 46 different reference products, she said.