Diplomat report highlights 2015 specialty approvals, 2016 expectations

FLINT, Mich. — Diplomat Pharmacy this week released a report on the state of specialty pharmacy at the beginning of a new year. The report from Diplomat’s clinical services highlights the fact that 2015 saw 45 novel new drugs approved by the Food and Drug Administration — more than the 28 that the years between 2006 and 2014 averaged. 

 

Among the 45 approvals, specialty drugs made up about half of them, with rare diseases and oncology medication approvals totaling 28. Diplomat’s report points out that FDA is favoring specialty medications over traditional ones when it comes to approval, adding that specialty is also driving spend (something IMS Health also noted in 2015).

 

“It's been a remarkable year,” Diplomat president Gary Kadlec. “The rise in FDA approvals for treatments of rare diseases is incredible for the people facing these conditions. Each approval offers new options and renewed hope for patient populations whose needs have gone unmet for so long.”

 

The report also pointed out that 60% of the approvals in 2015 received such designations as breakthrough, fast track, priority review and accelerated approval. It also predicted that the pipeline for 2016 is set to have the highest number of approval in oncology, with some dozen cancer drugs currently expecting approval.