| | CENTER FOR DRUG EVALUATION AND RESEARCH DIVISION of
DRUG INFORMATION Your source for the latest drug information. Know the moment it happens. | | FDA Approves Cimerli (ranibizumab-eqrn), First Interchangeable Biosimilar to Lucentis (ranibizumab injection) Today, the Food and Drug Administration approved Cimerli (ranibizumab-eqrn) injection, as biosimilar to, and interchangeable with, Lucentis (ranibizumab injection). This is the 37th biosimilar approval in the United States.
Cimerli is a vascular endothelial growth factor (VEGF) inhibitor and is approved for the same indications approved for Lucentis.
A biosimilar is a biological product that is highly similar to an existing FDA-approved biological product, known as a reference product. The biosimilar must also have no clinically meaningful differences in terms of safety and effectiveness from the reference product. A biosimilar sponsor may choose to also seek an interchangeability determination by demonstrating that their product also meets specific requirements outlined in the Public Health Service Act.
In addition to meeting the same standard for biosimilarity, additional requirements for interchangeability include a determination that the proposed interchangeable can be expected to produce the same clinical result as the reference product in any given patient; and that the risk in terms of safety or diminished efficacy of alternating or switching between the proposed interchangeable and the reference product is not greater than the risk of using the reference product without such alternation or switch. FDA's approval of an interchangeable biosimilar product does not indicate a higher standard of biosimilarity.
An interchangeable product may be substituted for the reference product at the pharmacy without consulting the prescriber—a practice commonly called "pharmacy-level substitution" — subject to state law. These laws vary by state. However, because ranibizumab products are injected into the eye, they are directly administered by the health care provider. FDA determined that no additional clinical data was needed beyond what supported the demonstration of biosimilarity in order to support licensure of Cimerli (ranibizumab-eqrn) injection as interchangeable with Lucentis (ranibizumab injection).
All FDA-approved biosimilar and interchangeable biosimilar products meet FDA's strict standards for approval. Once FDA-approved, these medications are just as safe and effective as the reference products they are compared to.
For more information about biosimilar products, visit www.fda.gov/biosimilars and see FDA's educational resources about biosimilar and interchangeable products for health care providers and patients. | | This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO- FDA (1-888-463-6332) or 301-796-3400 from 8:00 am - 4:30 pm ET Monday - Friday. You can also email us at: druginfo@fda.hhs.gov. | | | |
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