Amgen supports WHO’s proposed distinguishable naming policy for biosimilars

Amgen, a biotechnology company developing both innovative biologic and biosimilar medicines, supports the direction the World Health Organization (WHO) is taking with regard to their international non-proprietary naming (INN) policy for biologic medicines.

WHO has published minutes from the 55th INN Consultation meeting in October 2012 that outline the INN Committee’s proposed options for adopting a policy of distinguishable non-proprietary names for biologic medicines. The minutes outline the WHO’s objective to improve the current INN naming system to allow for global consistency and avoid inadvertent switching of products between patients in a sustainable way.

Amgen believes that healthcare systems globally must ensure all biologic medicines, including biosimilars, can be rapidly and accurately identified by national regulators, healthcare providers and patients. Distinguishable names for all biologics will reduce the likelihood of inadvertent and inappropriate product switching and strengthen the accuracy of tracing via post-marketing safety monitoring systems.

There can be practical challenges to reliably and accurately distinguishing one biologic medicine from another when our biosimilar medicines, and others, are introduced to the marketplace. While national healthcare systems can use multiple methods to identify medicines, including mandatory brand name prescriptions, reimbursement coding, or universal medical records, none of these systems are sufficient alone nor can they be generalized to all regions and settings. Distinguishable non-proprietary names are an easily implemented and reliable means of advancing accurate product identification.

Biologic medicines are distinct from chemical drugs in that no two products are expected to be exactly the same. Hence there are no generic biologic medicines, and it is appropriate for naming rules to reflect this globally.

Amgen encourages the INN Committee to adopt a formal process that requires distinguishable international non-proprietary names for biologic medicines, including our biosimilar products.