With the requirements of social distancing and new protocols for working off-site, the COVID-19 pandemic has affected nearly all sectors of business to some extent. Even if it has not greatly affected revenues, it has inarguably affected how we conduct our businesses. The overall effect on the ability of the US Food and Drug Administration (FDA) to regulate the biosimilar industry has been varied but negligible, according to the FDA’s Director of the Office of New Drugs.
In remarks by Peter Stein, MD, at the Drug Information Association’s virtual Biosimilar conference this week, he noted that FDA’s biosimilar development consulting program is very active, with 60 industry meetings scheduled so far in 2020. In addition, the new Office of Therapeutic Biologics and Biosimilars (OTBB) has completed a major update to the Purple Book, as well as undertaken several educational programs. He did note, however, that “progress with internal clearance of biosimilars has slowed somewhat due to COVID.”
According to our own database, four biosimilar applications were submitted within the last 12 months (Samsung Bioepis’s SB11 ranibizumab biosimilar has not yet filed a 351(k) application but applied for EMA approval on October 6).
Biosimilar and biologic approval rates have been affected, acknowledged Dr. Stein. “We need to assure the health and safety of the staff of the Office of New Drugs, while still giving comprehensive and thoughtful assessments,” he stated.
Beyond the effect of COVID-19 on the FDA, Dr. Stein continued, “Another important aspect that may slow biosimilar development is the need to protect the safety of patients entering trials.” This could be a delaying factor in any phase of clinical trials. It is yet to be seen whether this will truly be an issue, considering that FDA has deemphasized the need for late-stage clinical trials in many biosimilar categories. This may affect biosimilar insulin development, however. Sean McGowan, MBA, Senior Director, Biosimilars, AmerisourceBergen, pointed out that 6 biosimilar insulins are currently in some stage of development, with four in phase 2 or 3 trials.
Additionally, Dr. Stein pointed out that the pandemic has had a a slowing effect on inspections of manufacturing facilities, “but we did not think this affected biosimilars much at all,” he said.
Mr. McGowan mentioned that operationally, whereas COVID-19 may have slowed business, it did not slow AmerisourceBergen’s operations. “The pandemic did not affect the biosimilar market specifically,” he said, “but it affected biosimilars more broadly: There was a significant but temporary dip in the utilization of specialty products.” This amounted to a 10% to 30% reduction, depending on drug and geographic area (which may related to the region’s shut-down status). More specifically, the drop in utilization was likely the result of patients delaying care and sites of care being closed temporarily. “We’re seeing a good and solid recovery in clinical and health system spaces, after health care providers figured out how to treat patients safely,” he added.