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Office of Pharmaceutical Quality Report: Key Deadline Looming for BPCIA


The Office of Pharmaceutical Quality, charged with strengthening and building public trust in the US supply of medicine, notes that March 23, 2020, will mark a key turning point in the way that many biologics are licensed.

A long-anticipated change in the way a range of biologics are licensed will take effect on March 23, 2020, potentially opening the door for greater competition among these products—particularly insulin—and enabling manufacturers to take advantage of the biosimilars pathway for approval of these products, the FDA’s Office of Pharmaceutical Quality (OPQ) noted in its 2019 annual report.

The change, a milestone in the Biologics Price Competition and Innovation Act (BPCIA) of 2009, will affect not just insulin and insulin analogs, but also human growth hormone, pancreatic enzymes, and reproductive hormone products. “These products have faced limited market competition in the past,” the OPQ said in its report.

The new provision will change the classification of these drugs from “small molecules” to “biological products.” Until now, these agents have been approved via new drug applications (NDA) under the Food Drug and Cosmetic (FD&C) Act. The change will force drug developers to file biologic license applications (BLA) under the Public Health Service (PHS) Act in order to obtain marketing approval.

According to provisions of the BPCIA, affected drug products that were formerly approved under NDAs will be “deemed” to have been approved under BLAs.

In addition, The Further Consolidated Appropriations Act (FCAA) of 2020, signed into law on December 20, 2019, resolved some outstanding questions and concerns about how the change would affect drug developers and product exclusivity.

The FCAA provides a bridge for products that may only be tentatively approved or still under review as of March 23, 2020. Before the FCAA was enacted, NDA applications that passed this deadline without resolution would have been at risk of outright rejection.

The act also clarifies market exclusivity rights for products formerly licensed as NDA, particularly for orphan drug and pediatric exclusivity.

Prior to the FCAA, there were many concerns about the transition. Drug developers feared qualifying agents wouldn’t be approved by the March 23 transition and felt pressured to wait until the new licensing description took effect to avoid having to go through the approval process twice.

This waiting period created a multiyear regulatory dead zone during which the FDA wasn’t approving many drugs destined to move over to the BLA licensing platform, Scott Lassman, an FDA law and policy attorney, explained in a 2018 interview with The Center for Biosimilars.

According to the OPQ annual report, a public hearing in May 2019 allowed many insulin users and medical professionals to air their grievances about interchangeability of biosimilar insulin products. Rapid price increases and stockpiling of insulin products by patients were noted.

Norman E. Sharpless, MD, the FDA's former acting commissioner at the time of the meeting, said at the time that “not all pharmaceutical products are amenable to competition through the generic pathway. That has been the case for insulin products, because insulin is regulated as a biologic, meaning a complex molecule generally manufactured in living cells,” he said.

The BPCIA is one way the FDA is striving to encourage competition among developers of biologics, Sharpless said. “This means that insulin and insulin analogs will now be open to biosimilar competition, which in turn can lead to development of more affordable biosimilar insulin products, including products that are interchangeable with branded insulins, without any compromise in safety and effectiveness.”

The OPQ is charged with assuring that quality medicine is available for public use. It does this by integrating quality assessment, inspection, surveillance, policy, and research activities. The office also strives to give healthcare professionals confidence in the quality of drugs they prescribe to people to assure better knowledge and better availability of those drugs. They are also attempting to work more closely with manufacturing and development experts, field investigators, the Office of Compliance, and the Office of Regulatory Affairs to improve quality evaluations and reduce issues.

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