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Welcome to the Eighth Annual Payers’ Guide to New FDA Approvals

March 2017, Vol 10, Eighth Annual Payers' Guide - FDA Approvals, FDA Approvals, Drug Updates, Payers' Guide
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First appearing in 2010, this is the eighth annual Payers’ Guide to New FDA Approvals published by American Health & Drug Benefits. The goal of this Guide is to provide payers, providers, and other healthcare stakeholders a comprehensive review of new drugs that were approved by the US Food and Drug Administration (FDA) in the previous year, as well as new indications, new formulations, new patient populations, and the full scope of new drug-related approvals by the FDA in 2016. This practical, detailed, and evidence-based resource is intended to help guide medical and pharmacy directors with their benefit design decision-making and the development of coverage criteria.

A common observation made regarding the FDA approvals of new drugs in 2016 is the rather low number of new drugs approved, totaling only 22 new molecular entities (NMEs) and new biologic licensing applications (BLAs), which pales in comparison to the 45 NMEs and BLAs approved in 2015 and 41 NMEs and BLAs approved in 2014.

Regardless of the reasons for this reversal from previous years, a closer look at the new drugs that were introduced to market in 2016, as evident in this Guide, suggests that those new drugs are often not a mere repetition of drugs already on the market (or “me too” drugs). Rather, 2016 saw the introduction of many novel biologics and novel molecules becoming available for patients for the first time ever.

Indeed, as noted in the Introduction to this issue, innovation continues to be a key driver of drug development, as evidenced by the increasing numbers of first-in-class drugs approved by the FDA in 2016, and the increasing reliance of the FDA on its accelerated review, fast track and/or breakthrough designation granted to many new drug applications.

Improving on the trends seen in recent years, of the 22 NMEs and BLAs approved by the FDA in 2016, 8 were first-in-class drugs, and 9 were for rare diseases.

As in previous years, this Guide includes a comprehensive directory of all the NMEs and BLAs approved by the FDA in 2016, as well as a list of all new indications, combinations, formulations, dosages, dosage forms, patient populations, biosimilars, and vaccines.

And as in previous years, this year’s Guide also includes a select list of comprehensive updates on some of the new drugs and important new indications approved in 2016.

We hope this Guide serves as a useful tool for applying up-to-date information on new pharmaceuticals into benefit design decisions and patient care and encourages further dialog related to innovation in drug development.

This Guide is also available online at
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Last modified: August 30, 2021