If numbers are anything to go by, 2014 was the year of the biologic. Nearly a fourth of the 41 novel drugs the FDA approved last year were biologics.
That's up fivefold from the previous year. Although only two novel biologics – Genentech Inc.'s Gazyva (obinutuzumab) and Kadcyla (ado-trastuzumab emtansine) – were approved in 2013, the FDA received 12 biologic license applications (BLAs) that year, setting the stage for the banner number of approvals in 2014. (See BioWorld Today, Jan. 17, 2014.)
All in all, 2014 was good for new drugs in general, according to an FDA report released this week. The 41 approvals of new drugs and biologics is the largest number in the past decade and a 52 percent increase over the 27 approved in 2013. Last year also was a record breaker in other ways. "We approved more 'orphan' drugs for rare diseases than any previous year in our history," the FDA's Janet Woodcock said. Seventeen, or 41 percent, of the new drugs