Ensuring the Safety and Commercial Success of Biosimilars in the United States

The forthcoming arrival of biosimilars into the U.S has spurred debate over the approaches that the FDA and industry should take to ensure patient safety while promoting market competition and continued biomedical innovation. During a presentation Tuesday at the 2014 BIO International Convention, participants at this Super Session focused on the need for prescribing physicians and providers to closely partners with one another to ensure that safety and efficacy are the priorities in the debate over biologics and biosimilars.

Dr. Robert Yapundich, a neurologist, referred to biologic agents as “the tools in my shed” for helping his patients manage conditions. He said he’s come to appreciate both the complexity of biologic drugs and their positive impacts on his patients. As a provider on the front lines of treating patients, Dr. Yapundich said he must weigh the benefits and risks of prescribing certain drugs, especially for patients with multiple complex conditions. That’s never easy, and treatment becomes more complex in situations where communication breaks down, such as when a change is made with a pharmacist but not communicated.

Phillip Schneider, associate dean and a professor at the University of Arizona College of Pharmacy, said that healthcare reform is necessitating more collaborative models of care. Providers – from the primary care physician to the pharmacist – need to be talking to each other to ensure that biologics are being used responsibly and effectively. Schneider noted that the pharmacists often seen as the last point of care for the patient. Because many patients see their pharmacists more than their physicians, it’s critical for pharmacists to ensure they take proactive approaches to communicating with both patients and providers.

Both Schneider and Yapundich agreed that approaches for governing the use of biosimilars and biologics cannot put undue administrative burdens on pharmacists and physicians, who want more time to focus on meeting the needs of their patients. A lot of common ground exists between pharmacists and physicians. The groups are always concerned about doing right by their patients, are knowledgeable about medications, and are interested in tracking outcomes and adverse events. Prescribing medications and helping patients manage them are complex processes for both parties.

Marcia Horn, president and CEO of the International Cancer Advocacy Network, said its “inconceivable that a physician would not be informed of a substitution.” She stressed the importance of immediate notifications for patients and providers in such situations, saying that substitution should occur only when the FDA has designated biologics as interchangeable. Noting that more states have passed or are introducing legislation to regulate the use of biosimilars, she said patients and caregivers who have experience with biologics should make themselves heard at hearings.

All three panelists agreed that the greatest value for patients occurs when the efforts are collaborative. More importantly, their collective hope is that any legislation puts patient safety as the main focus. While the cost of medications is a concern in an era of healthcare reform, it should never trump safety and efficacy.

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