Food and Drug Administration approvals of biologic drugs represented 28% of all new drug approvals in the last 21 months, up from 17% over the 2010-13 period, Fitch revealed in its latest Global Pharmaceutical R&D Pipeline report.
“Biologics will continue to take a larger share of new drug development in the next few years, although their impact on sponsor companies remains uncertain,” stated director Robert Kirby of Fitch.
Since August, two biologics for treating high cholesterol have been approved: Repatha (from Amgen) and Praluent (from Sanofi), signaling biologics’ entrance into the cardiovascular market.
Fitch noted that, as with other drugs approved for hard-to-treat patients, debates about pricing continue. The rating agency said it believes the FDA will continue to focus on priority drug reviews for drugs that serve unmet medical needs. The number of new molecular entities approved by the FDA in the first nine months of 2015 fell by four versus the same period last year.
In September, Fitch said the debut of the nation’s first biosimilar drug — Sandoz’s Zarxio, a biosimilar of Amgen’s oncology drug Neupogen — could mark the start of a gradual conversion for the U.S. pharmaceutical drug market as biosimilars begin to take share from their reference biologics. The FDA approved Zarxio in early March as the first biosimilar to navigate the new 351(k) pathway.