At Long Last, Progress

Specialty Pharmacy TimesMarch/April 2016
Volume 7
Issue 2

DESPITE THE SIGNIFICANT ADVANCES IN SPECIALTY DRUG DEVELOPMENT in recent years, it can seem like a slow crawl getting these treatments from FDA evaluation to market, especially for patients anxiously awaiting these life-changing therapies. But the tide, it would seem, has started to turn.

A recent report by the California Life Sciences Association and The Boston Consulting Group found that significant progress has been gained by the FDA in accelerating review times. The study revealed that FDA review times dropped from an average of 21 months in 2009 to 10 months in 2015.

The researchers found that review times in the therapeutic areas of oncology, infectious diseases, and rare diseases were particularly fast. This progress is especially notable because getting new treatments into the hands of these patients is literally a matter of life and death, in many cases.

For patients with rare diseases, the new treatments are often the first drugs to gain approval for these conditions. In fact, 36% of the medications approved in 2015 were first-in-class drugs, of which nearly half were for rare diseases. While the continued concerns surrounding the high cost for many of these drugs continues, relief may be looming as the accelerated FDA review process should also speed the impending arrival of new biosimilars.

This is significant, as the entry of biosimilars into the prescription drug market could generate a projected total savings of $110 billion over the next 5 years across the United States and Europe, according to a report released by the IMS Institute for Healthcare Informatics. The report found that opening markets to biosimilar competition could result in a 30% reduction for health systems in price per treatment day compared with originator biologics.

In terms of research and development, 30 companies are actively pursuing biosimilars for 16 distinct molecules that could increase competition by 2020. As these new treatments hit the market, specialty pharmacy will be at the forefront helping patients get the most out of these therapies. For that reason, it’s incumbent for stakeholders to stay abreast of the myriad issues facing the specialty landscape.

I urge you to read the feature article in this edition of Specialty Pharmacy Times by National Association of Specialty Pharmacy board member Mike Agostino, who goes in depth on the urgent need for health care professionals to stay involved and stay true to specialty pharmacy. Staying on top of the latest developments in the specialty landscape is our mission in the print edition of Specialty Pharmacy Times, and our daily news website,, which keeps you abreast of all the latest news you need to know. Follow our coverage in print, online, in our e-newsletters, and on mobile devices. SPT

Thank you for reading!

Mike Hennessy, Sr


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