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Webinar Offers Primer on Biosimilars Policy

If policymakers get it right, biosimilars could offer more safe and effective treatment options for patients in the coming years – potentially at lower costs. This was the message of a recent biosimilars webinar tailored for bloggers, which offered the perspectives of a health care provider, a policy expert and a member of the patient advocacy community.

Background on Biosimilars

Iris Zink, a rheumatology nurse practitioner, began the webinar with an introduction to biologics and biosimilars. Roughly 200 biologics have “transformed the lives of 800 million patients with serious illnesses,” Zink explained, highlighting diabetes, cancer and inflammatory diseases.

Zink went on to explain the complexity of biological drugs and their manufacturing process. Begun with a unique cell line, these medications’ purification and growth process “can take months,” Zink noted. She added that the drugs were responsive to subtle changes in light and pH balance. Zink also explained the challenges of immunogenicity – whereby the body outsmarts the medicine and causes the drug to lose efficacy over time.

Drawing an analogy to intricate snowflakes, Zink noted that biosimilars can be highly similar to the original biologic but never identical.

Policy Issues

Amgen’s Kim Greco followed with an overview of biosimilar policy. Greco outlined different proposals for naming biosimilars, highlighting the use of four-letter suffixes to differentiate among the similar drugs. She noted the need for clear identifiers should anything go awry with manufacturing or handling. “Biologics are sensitive,” Greco reiterated, “and this is a human endeavor…sometimes things don’t go as planned.”

Greco also reviewed the value of transparent drug labels, which can help physicians make informed decisions about the medicines they prescribe. She noted that labels should state “interchangeable with…” when biosimilars are designated as interchangeable by the FDA.

[WATCH: What Physicians Need to Know to Safely Prescribe Biosimilars]

The FDA has not yet issued final guidance on how biosimilars will be named or labeled.

The Global Healthy Living Foundation’s Stephen Marmaras pivoted to the importance of state policy. State policymakers will determine whether a state’s pharmacists must notify prescribing physicians when they substitute a biosimilar for a patient’s prescribed biologic. The foundation’s 50 State Network has advocated for notification laws across the country to encourage transparency, safety, and physician awareness and confidence.

Iris Zink noted that “morally and ethically, we’ve all been waiting” for biological treatment options at lower costs. Greco noted that the extent and impact of cost savings remains to be seen, but that “we do anticipate cost savings” through the use of biosimilars.

The webinar was hosted by Amgen, which develops both biological and biosimilar medications.

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