EPISODE 84: From Science to Patient Care: Understanding Biosimilars in Osteoporosis Treatment
Dr. Cate Lockhart
As biosimilars become increasingly available for osteoporosis treatment, patients may have questions about how these medications compare to original biologic drugs, whether they're safe and effective, and what they mean for their treatment options.
On this episode of Bone Talk, Ami Patel, Vice President of Science & Education at the Bone Health and Osteoporosis Foundation, welcomes Cate Lockhart, PharmD, PhD, Chief Science Officer at the Academy of Managed Care Pharmacy and Executive Director of the Biologics and Biosimilars Collective Intelligence Consortium. Together, they discuss the science behind biosimilars, the FDA approval process, and how these medications may help make osteoporosis treatment more accessible and affordable.
Key Takeaways
Understanding Biosimilars: Biosimilars are biologic medications that are highly similar to an FDA-approved reference biologic medication, with no clinically meaningful differences in safety, effectiveness, purity or potency. Unlike generic medications, which are chemically identical to their brand-name counterparts, biosimilars are made using complex biological processes.
Safety and Effectiveness: Biosimilars undergo rigorous FDA evaluation before approval. With more than a decade of use in the United States and approximately 20 years of experience in Europe, research and real-world evidence continue to support the comparable safety and effectiveness of biosimilars and their reference biologic medications.
The Importance of Real-World Research: Clinical trials provide essential information about medication safety and effectiveness, but real-world studies help researchers understand how treatments perform in everyday healthcare settings. This research offers valuable insights into patient experiences and outcomes beyond controlled clinical trials.
Switching Between Biologics and Biosimilars: Patients may be switched from a reference biologic medication to an approved biosimilar because of insurance coverage, treatment preferences or other factors. Research shows that switching between a reference biologic and its biosimilar generally does not compromise safety or effectiveness. Patients should discuss any medication changes with their healthcare providers to understand their treatment plans.
What Interchangeable Really Means: An interchangeable biosimilar isn't necessarily safer, more effective or higher quality than another FDA-approved biosimilar. In the United States, the designation allows pharmacists to substitute an interchangeable biosimilar for its reference product without first contacting the prescriber, subject to applicable state laws.
Expanding Access and Reducing Costs: Biosimilars introduce competition into the market, helping lower the cost of expensive biologic treatments. Dr. Lockhart discusses how biosimilar use has generated substantial savings across the U.S. healthcare system. While lower costs do not always translate directly into lower out-of-pocket expenses for individual patients, increased competition may help improve access to biologic medications.
Empowering Patients Through Education: As biosimilars become more common in osteoporosis care, patients are encouraged to ask questions and stay informed. Healthcare providers and pharmacists can explain how biosimilars work, why a particular medication is recommended, and what patients should expect during treatment.
What Does This Mean for People With Osteoporosis?
As biosimilars become more widely available for osteoporosis treatment, patients may have additional options for managing their bone health. These medications offer the potential to improve access to treatment and reduce costs while maintaining the safety and effectiveness of their reference biologic medications.
Although biosimilars are relatively new to osteoporosis care, extensive research and years of experience treating other conditions provide a strong foundation of evidence supporting their use.
For patients who are starting treatment or considering a switch to a biosimilar, understanding their options is important. Talking with a healthcare provider or pharmacist about how a biosimilar works, why it may be recommended, and what to expect can help patients make informed decisions and stay on track with their osteoporosis care.
