Educating the public about biosimilars
Friday, March 02, 2018
In recent years, knowledge of the existence of biosimilars has grown. A biosimilar is a biologic medicine that is shown to be similar to an approved innovative biological product or drug. Unlike generic drugs, in which the active ingredients are identical, biosimilars do have key differences from the reference product.
Given the complex nature of the properties of these biologics, Congress and the Food and Drug Administration (FDA) designed an expedited pathway for the approval of biosimilars. But with this abbreviated approval process comes the need for improved patient education on the use of these agents, according to Patients for Biologics Safety & Access (PBSA).
PBSA, a patient advocacy group, recently sent a letter to the FDA asking to help make the public more aware of the importance of biosimilars as this class of agents continues to grow. For instance, the recommended changes include providing clearly defined distinction between biosimilars and biologics, as well as defining key terms that consumers may not know and need to know as it pertains to understanding of biosimilars.
"The FDA plays a critical role in educating stakeholders and the public about biosimilars and has made a much needed start with its introduction of educational materials for prescribers," said Larry LaMotte, vice president of public policy at the Immune Deficiency Foundation and lead coordinator of PBSA, in a statement.
One of the key items from the list includes shining a light on the importance of having a patient-doctor relationship as it relates to the prescribing of biologics vs. biosimilars. In order for patients to fully understand what they are being prescribed, patients must have candid and open discussions with their provider.
The hope is to have patients be viewed as valuable members of the therapeutic relationship and collaborate with providers when it comes to the quality and type of healthcare services they are provided.
"PBSA believes that our suggested changes will help provide more complete and robust policy and clinical elements and better assure that prescribers can effectively talk to their patients about the complex world of biosimilars," LaMotte said.
The need for improved patient education is emphasized with the use of biosimilars to manage more chronic conditions such as autoimmune diseases and the need for patients to be thoroughly informed about not only the efficacy but also the safety concerns of these products. For the use of biosimilar to be successful in the U.S., the information that is provided to both patients and clinicians must be accurate and clear.
While the PBSA strives to promote the education of patients and providers about the use of biosimilars, other organizations believe the bigger picture is being missed: promoting the affordability of these agents and lowering the costs that are being incurred by patients. Biosimilars are believed to be more affordable therapeutic options but are not expected to generate the same degree of cost savings that can be identified with generics.
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