Improving patient access to affordable high-quality medicines is a core value of companies that develop and manufacture generic and biosimilar medicines. Our companies produce and distribute the treatments that make up 90% of prescriptions filled in the U.S., at just 12% of the total prescription drug costs.
On behalf of our member companies, we serve as a key pillar in the U.S. healthcare system. Our work includes promoting marketplace competition and supporting strategic enhancements to the Food and Drug Administration’s (FDA) generic drug and biosimilar approval process.
We do this for one purpose: to put affordable, quality medicines within reach of America’s patients to improve health outcomes and lower healthcare costs.
View AAM’s Commitment to Quality
Generic and biosimilar manufacturers are fundamentally committed to product quality. A continuous and significant investment in quality excellence manifests the industry’s deeper purpose of safeguarding patients and its responsibility to protect public health through rigorous science, robust quality systems, and resilient supply chains. As a result, AAM and its member companies’ have an outstanding track record for safety and ensuring U.S. patients have access to high-quality, safe and effective generic and biosimilar medicines.
Every process that generic and biosimilar manufacturers engage in – from raw material sourcing, to manufacturing, distribution and post-approval monitoring – is purposefully and carefully designed and implemented to ensure Americans can rely on the treatments they use every day. Industry best practices include the adoption of Quality by Design principles to proactively build quality into the entire pharmaceutical product lifecycle.
The U.S. has high standards, long considered the gold standard globally, to ensure the safety, efficacy, and quality of all pharmaceuticals manufactured for U.S. patients, regardless of where they are manufactured and whether they are originator, generic, or biosimilar medicines. FDA applies these high standards not only during the approval process but also throughout the product life cycle. These quality standards and regulatory requirements, by design, include multiple safeguards and redundancies to help ensure quality. Generic drug and biosimilar manufacturers’ commitment to product quality and the industry’s implementation of these multiple, layered safeguards pursuant to FDA oversight ensures generic and biosimilar medicines are of consistently high quality.
AAM and its members remain committed to continuous quality improvement and to working collaboratively with FDA and other stakeholders to promote a regulatory environment that supports patient access to high-quality, safe, and effective generic and biosimilar medicines.
View AAM’s Commitment to Quality
