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Generic and Traditional Drugs Also Influence High Costs

Mary Beth Nierengarten
January 2016

More than $25 billion in first-time generic drugs became available in 2015, with another $19 billion expected in 2016, according to AMCP 2015 Nexus speaker Chris Peterson, PharmD, director of emerging therapeutics, Express Scripts Holding Company.

In his presentation, “Traditional Brand and Generic Drugs in Development,” Dr Peterson discussed the 2016 pharmaceutical pipeline and what branded and generic drugs are likely to emerge from it as well as the impact these approvals may have on the managed care market.

SOURCE OF DRUG SPEND

Managed care professionals should recognize that, along with the high cost of specialty drugs, newly branded and first-time generic drugs will impact their drug spend.

“While the high cost associated with specialty drugs is very important to monitor, drugs that fall under the traditional pharmacy continue to impact drug spend with the introduction of new brands and first-time generics,” he said. “These drugs will compete within many of the top therapy classes.

FDA APPROVALS

In 2014, the FDA approved 41 new molecular entities or therapeutic biologic license applications. Dr Peterson said that the FDA is currently on track to at least match this number of significant approvals.

“While a large portion of the approvals are specialty, traditional drugs have the potential for a broad use in very large patient populations,” he said. “Although many of the traditional drugs may not be considered ‘novel,’ they will provide additional competition within existing therapy classes.”

The bulk of Dr Peterson’s talk was a recitation of branded drugs and generics approved in 2015 (Table 1), along with drugs in the pipeline in 5 therapy classes. Table 2 lists the branded drugs already approved in 2015 for the 5 therapy classes.

Among the branded drugs anticipated to go generic in 2016, he said, are several larger ones including Crestor (rosuvastatin calcium), Benicar (olmesartan medoxomil), Seroquel XR (quetiapine fumarate), and Zetia (ezetimibe).—Mary Beth Nierengarten 

 

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