Amgen Statement on Support for Sound Science-Based Biosimilar Policies

Amgen openly welcomes discussions and seeks appropriate common ground with all healthcare stakeholders on key policy issues, such as state biosimilar substitution legislation and distinguishable naming.

As states update their drug substitution laws to address biological products, Amgen believes they should adopt policies to ensure that automatic substitution follows FDA recommendations for products determined to be interchangeable. We also support extending current drug substitution rules to these biologics, and adoption of pharmacovigilance measures to help facilitate accurate and complete patient medical records.

Amgen is seeking distinguishable non-proprietary names, including the use of an identifier, for our biologic medicines. Simply put, distinguishable non-proprietary names are a practical and reliable means of advancing accurate product identification. We share this perspective with a diverse group of stakeholders, including many other biotech companies.i