Biosimilar Approval Brings New Awareness Levels for Community Pharmacists

APRIL 15, 2015
Eileen Oldfield
The FDA’s March 6, 2015, Zarxio approval brought biosimilars into the spotlight once again, although Zarxio and other biosimilars continue to face hurdles. Community pharmacists should remain aware of the therapies in order to better assist their patients.

“Even though this may not be the biggest component of the day for a community pharmacist, they’re still going to get questions about it,” said Steven Lucio, PharmD, BCPS, senior director of Clinical Solutions and Pharmacy Program Development at Novation, in an interview with Pharmacy Times. “Being the local drug information experts, pharmacists are going to have to field these requests, and have to be prepared, even though they may not be dispensing the majority of these agents.” That may be the case with Zarxio, which tends to be administered in inpatient settings, outpatient clinics, and physician offices, or is provided by a specialty pharmacy, he added.

“As all health care providers begin to be reimbursed more on outcomes, all pharmacists, including retail practitioners, will need to ensure that patients are taking their medications as prescribed and that there is no confusion between biosimilars and branded medications,” he said. “Even if a patient is not getting their Zarxio from a retail pharmacy, they may be getting their other drugs in this setting. Therefore, retail pharmacies need to be able to field patients’ questions about this product and others.”

Biosimilars vs Branded Drugs
Biosimilars’ impact on community pharmacy will likely increase as the FDA approves more agents, as well as when the therapies receive the interchangeability designation that creates the path for biosimilar substitution. Still, it might be some time before Zarxio reaches patients, due, in part, to fluctuations in the biosimilar pathway and the biosimilar market. Currently, the product is undergoing patent litigation, which can involve the originator manufacturer analyzing the biosimilar data for patent infringements, Dr. Lucio said.

“Pharmacists have a huge role in ensuring the safe and effective adoption of biosimilars,” Dr. Lucio said. “Pharmacists will be the primary source of validated information for physicians and patients. This audience will have a lot of questions that will have to be answered correctly and effectively.”

The FDA has not yet released its final stance on biosimilar naming conventions, nor has it established criteria for biosimilar interchangeability. Although intended to occupy the same therapeutic place as traditional generic drugs, biosimilar products are not generics, Dr. Lucio added. The increased size and complexity of branded medications makes creating an identical replica impossible. This should not be cause for concern, however: branded biologic drugs vary from batch to batch and from lot to lot, which is expected for these types of products, he added.

Biosimilar products should work just like branded drugs, even though they are not exact duplicates of the branded biologics: the products have the same safety and efficacy as branded products but no clinically meaningful differences from the original product.

“Pharmacists should be comfortable filling prescriptions and dispensing biosimilars once they come to market,” Dr. Lucio said. “Various biosimilar drugs have been approved and marketed in Europe since 2006. Those products have worked as expected with similar safety and efficacy profiles … compared [with] the branded drugs.”