2021 Generics and Biosimilars Outlook
This article first appeared in Chain Drug Review on January 5, 2021 as Pharmacy Outlook: Dan Leonard.
This article first appeared in Chain Drug Review on January 5, 2021 as Pharmacy Outlook: Dan Leonard.
AAM’s core mission is to improve patients’ lives by advancing timely access to affordable, FDA-approved generic and biosimilar medicines. AAM is the nation’s leading trade association for manufacturers and distributors of generic and biosimilar prescription medicines. Our members provide more than 36,000 jobs at nearly 150 facilities, and manufacture more than 61 billion doses of prescription medicine in the US annually.
Key Points:
AAM Statement on Generic Drugs in Medicare Part D. Trends in Tier Structure and Placement, Avalere Health, May 22, 2018:
“In 2015, patients spent more than $6 billion in additional out-of-pocket costs on generic drugs compared to 2011. These increased out-of-pocket expenses on low-cost generics are being used by the plans to mask increases in branded drug prices.”
Avalere Health study funded by Association for Accessible Medicines.
Congress Signals Intention to Pass Legislation Needed to End Games
WASHINGTON DC (May 17, 2018) – Today, the Food and Drug Administration (FDA) for the first time publicly identified brand-name pharmaceutical companies who abuse FDA’s safety programs or erect their own restricted distribution systems without an FDA mandate to delay competition from generic and biosimilar manufacturers. These anti-competitive tactics artificially extend the monopolies on blockbuster brand drugs and keep drug prices high for millions of patients.
A virtuous cycle of innovation and access has served as the foundation for our nation’s prescription drug market since the presidency of Ronald Reagan. When that market worked as Congress originally intended around the time of enactment of the Hatch-Waxman amendments in the 1980s, patients benefited from lifesaving new drugs; they maintained their health with generic medicines; brand drug makers recouped their investments, rewarded shareholders and were incentivized to discover new therapies and cures; and the makers of generics had thriving businesses.
The Association for Accessible Medicines (AAM) has established a new Code of Business Ethics to memorialize the ethical and business standards to which our member organizations will be held. Unanimously endorsed by our Board of Directors, the code takes effect on September 1.
Prescription drugs treat conditions and improve patient health. But when drug prices are too high, access to medicines becomes out of reach for far too many patients.
WASHINGTON, DC (October 31, 2017) – AAM and our member companies are committed to supporting policies that promote competition and help speed the availability of generic and biosimilar medicines to patients.
AAM is fully committed to compliance with all laws and ethical business practices.
Attribution: Jeff Francer, Senior Vice President and General Counsel