Diplomat Publishes New Report on Specialty Drugs Approved in 2015 and Expected for 2016
FLINT, Mich. – January 6, 2016 – The nation’s largest independent specialty pharmacy has published a new report on specialty therapies, including approvals in 2015 and the pipeline for 2016.
Diplomat Pharmacy, Inc. (NYSE: DPLO) announced today that it has published a new report on the state of specialty pharmaceuticals, including a recap of FDA approvals in 2015 and an overview of the pipeline for 2016.
The report, written by Diplomat’s Clinical Services division, offers insights on the year’s developments in emerging specialty therapies. This year, the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER) approved 45 novel new drugs. This is the highest total since the creation of the Prescription Drug User Fee Act and is well above the average of approximately 28 approvals per year from 2006 to 2014. Of the 45 novel new drugs approved this past year, CDER identified 16 (36 percent) that were the first drug of their class to earn approval, one indicator of the innovative nature of a drug.
Specialty drug products accounted for approximately half of the total new drugs and biologics approved by the FDA in 2015. Of the specialty agents approved in 2015, the areas with the most approvals were rare diseases (25) and oncology (13). The impact of specialty drugs continues to increase in both drug utilization and spend. FDA approvals have increased in recent years, favoring more specialty medications than traditional ones in the past five years.
“It’s been a remarkable year,” said Gary Kadlec, Diplomat’s president. “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.”
According to the FDA, in 2015, the recent trend of increased FDA approvals continued with a greater than average number of drug approvals compared to past years. Special FDA designations—such as breakthrough, fast track, accelerated approval, and priority review—have been applied to promising drugs or those that treat diseases with an unmet medical need. These designations allow for expedited development through clinical trials and/or accelerated FDA review. Of the 45 novel new drugs approved this past year, 60 percent earned at least one of these special designations.
The pipeline for 2016 is forecasted to have the highest number of approvals in oncology, with approximately one dozen expected approvals for a variety of cancers.
To view the report, please click below.
To learn more about Diplomat, visit www.diplomat.is.
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements give current expectations or forecasts of future events or our future financial or operating performance. The forward-looking statements contained in this press release are based on management’s good-faith belief and reasonable judgment based on current information. These statements are qualified by important risks and uncertainties, many of which are beyond our control, that could cause our actual results to differ materially from those forecasted or indicated by such forward-looking statements. For a discussion of such risks and uncertainties, you should review Diplomat’s filings with the Securities and Exchange Commission, including “Risk Factors” in Diplomat’s Annual Report on Form 10-K for the year ended December 31, 2014 and in subsequent reports filed with or furnished to the Securities and Exchange Commission. Except as may be required by any applicable laws, Diplomat assumes no obligation to publicly update such forward-looking statements, which are made as of the date hereof or the earlier date specified herein, whether as a result of new information, future developments or otherwise.
Diplomat (NYSE: DPLO) serves patients and physicians in all 50 states. Headquartered in Flint, Michigan, the company focuses on medication management programs for people with complex chronic diseases, including oncology, immunology, hepatitis, multiple sclerosis, HIV, specialized infusion therapy and many other serious or long-term conditions. Diplomat opened its doors in 1975 as a neighborhood pharmacy with one essential tenet: “Take good care of patients, and the rest falls into place.” Today, that tradition continues—always focused on improving patient care and clinical adherence. For more information visit www.diplomat.is. Follow us on Twitter and LinkedIn and like us on Facebook.
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Gary Rice, RPh, MS, MBA, CSP,
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