Biosimilar Rollout Relies on Pharmacists

Significant challenges remain due to lack of FDA action on existing biosimilar approval guidelines.

Pharmacists will play key role in bringing biosimilar medications to US markets, both before the therapies receive FDA approval and after they become available.

However, introducing the therapies continues to present a hurdle for manufacturers, Philip E. Johnson, MS, BSPharm, FASHP, director of oncology at Premier, Inc, expressed during a symposium at the American Society of Health-System Pharmacists 2014 Midyear Clinical Meeting.

The most significant hurdle involves the lack of FDA action on the existing biosimilar approval framework. Despite the framework’s 2010 approval under the Affordable Care Act, and the FDA’s 2012 biosimilar regulatory approval guidelines, components of its interchangeability designation remain unclear to manufacturers and health care professionals alike.

The naming standards debate continues to be a point of contention for originator biologic manufacturers, health care providers, and safety organizations, as well. According to Johnson, 4 naming strategies have come to the debate’s forefront: using different names for originator and biosimilar products, using the same name for each product, using a unique suffix for the biosimilar product, and using a unique prefix for the biosimilar product.

Johnson said filgrastim (Neupogen), the first biosimilar medication submitted for FDA approval, should influence US naming standards for biosimilar products, although the outcome in this area remains unclear.

Market factors influence each of the various naming options without a clear winner, Johnson said. Originator manufacturers prefer different names for the biosimilars, but critics say it could lead to confusion and increase sound-alike and look-alike errors. Meanwhile, various health care organizations, including the Institute for Safe Medication Practices (ISMP), prefer unique prefixes that identify biosimilar products.

The naming conundrum enforces the importance of pharmacovigilance within biologic and biosimilar therapies. In markets that require new names for biosimilar drugs, confusion about the medications has led to patients receiving incorrect therapies, Johnson noted.

Dosing also remains a problem within the biosimilar space, particularly in the area of dosing standards, Johnson continued. Although current practice favors gram dosing for biologic products, this standard may change as biosimilars enter the market.

Currently, the debate focuses on whether such standards should be created before or after biosimilars enter US markets.