In this recent CME offering from ClinicalSeriesLive, “The Advancement of Biosimilars: A New Frontier in Medicine, Clinical Applications and Concerns Regarding Biosimilar Products,” viewers gain valuable insight into the testing, approval, and use of biosimilars or treatment of various diseases.
As of the production of the video, the only biosimilar approved by the FDA is Zarxio, manufactured by Sandoz. Zarxio is approved for the same indications as Nuepogen. The European Union approved several biosimilars to the FDA’s one, but several drugs are at various stages of the abbreviated Biologics License Application program and may gain FDA approval soon.
Dr. Jonathan Kay from the University of Massachusetts Medical School, Andrew Evens, DO from Tufts University School of Medicine, and Alissa Segal, PharmD form the Joslin Diabetes Center share the presentation, each offering their unique perspective on the use of biosimilars.
Video Excerpt: “What is a Biosimilar?” from the session.
There was lively discussion on the extrapolation of indications for biosimilars, including factors to be considered and challenges to be faced. Some diseases being considered are rheumatoid arthritis, psoriasis, juvenile inflammatory arthritis, and ankylosing spondylitis. South Korea, the European Union, Columbia, Turkey, and Australia have approved Biosimilar Infliximab to be used for six diseases.
Manufacturing Issues with Biosimilars
Manufacturing challenges resulted in altered biopharmaceuticals leading to decreased immunogenicity. Changes in formulation or packaging have resulted in increased immunogenicity with clinical consequences. In areas of the world where it is difficult to maintain constant storage conditions, this has been documented as an issue.
Though biosimilars offer great potential as treatment options, the panel cautions us there is no “one size fits all” treatment modality. Some may be used interchangeably, as a ‘switch,’ or in substitution. According to Section 7002 of the US Affordable Care Act, the term “interchangeable…means the biological product may be substituted for the referenced product without the intervention of the health care provider who prescribed the reference product.” Discussion around the interchangeability of biosimilars sparked a comparison between this type of regulation and the prescription and use of medicinal marijuana.
The panel states there are three types of testing/trials that should be conducted before use becomes widespread in the US.
- Switching (transitioning to biosimilar after initial treatment with originator)
- Substitution (a switch to or from a biosimilar, but only once during treatment)
- Interchangeability, where the patient can be transitioned back and forth from the biosimilar to the original, or vice versa
We must keep in mind, too, the studies are being conducted only between the reference (original) medication and a single biosimilar, but not between the reference medication and multiple biosimilars or solely among biosimilars.
In-depth consideration is given to pharmacovigilance, including the explanation of why we will need a system of nomenclature to distinguish biosimilars from reference products.
To learn more about the advancement of biosimilars, please view this CME offering from ClinicalSeriesLive by clicking on the title here: “The Advancement of Biosimilars: A New Frontier in Medicine.”
Disclaimer: All ClinicalSeriesLive articles, reports, summaries, and recaps of events are for informational purposes. The quotes and opinions of the speakers covered are not to be taken as direct advice for individual patients. Patients should always seek care from qualified, properly accredited healthcare professionals.