Specialty Pharmacy Drugs: 2016 Approvals and 2017 Forecasts

A new report on the current state of specialty pharmacy, significant FDA approvals in 2016, and the drug pipeline for 2017 was recently published by Diplomat Pharmacy, Inc.

Compared with 2015, less than half of the amount of new drugs were approved by the FDA in 2016. Of the 22 novel drugs approved in 2016, 17 specialty drugs were granted expanded indications, according to Diplomat.

Seven new biologics were approved, which included a mix of immunology, rare diseases, oncology, and medications for other disease states.

Although there were fewer drug approvals in 2016, it does not signify slower growth in the specialty marketplace, and does not account for the impact of the drugs that were approved, Diplomat reported.

“The specialty pharmacy industry continues to show exceptional growth,” Paul Urick, president of Diplomat, told Yahoo Finance. “The development of new drugs, as well as expanded indications for previously approved treatments continues to make the robust specialty drug pipelines one of the major drivers of growth.”

Diplomat expects a fairly wide scope of drugs to enter the market in 2017 across specialty disease states. Additionally, they expect more novel oral oncology drugs to be approved this year compared with 2016, with several approvals forecast in breast and blood cancers.

Thirty-one specialty drugs are expected to be approved in 2017, with several drugs in particular to monitor in the coming months, according to Diplomat.

If approved in the first quarter of 2017, ocrelizumab will be the first drug specifically indicated for primary progressive forms of multiple sclerosis (MS), which affect approximately 15% of all MS patients, and will be a viable treatment option for individuals with relapsed-remitting MS.

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