The Food and Drug Administration on Monday launched an educational campaign to ensure healthcare providers are well informed about biosimilars, according to an agency blog post.
Here are four things to know.
1. At present, the FDA has approved seven biosimilar drugs, which are highly similar versions of biologic drugs.
"As more biosimilars are approved by FDA, we want healthcare providers to understand what these drugs are, and how they can help patients," FDA commissioner Scott Gottlieb, MD, and Leah Christl, PhD, associate director for therapeutic biologics in the agency's Office of New Drugs, wrote in the post.
2. The FDA conducted extensive research and learned what questions providers had about biosimilars before developing educational materials for the campaign.
3. Resources include fact sheets and informational graphics for providers that:
- Define terms like "biological product" and "interchangeable" to clarify the relationship between biosimilars and their reference products
- Describe the regulatory pathway for biosimilars to earn approval and highlight the rigorous standards they must meet
- Provide information on what data the agency reviews to determine biosimilarity to the reference product.
4. The FDA believes biosimilars may reduce costs for patients and the U.S. healthcare system by achieving more market competition.
"As with the significant savings that we've seen through the introduction of generic drugs in the United States, biosimilars could also lead to substantial savings, thereby potentially improving access and promoting better public health outcomes," Drs. Gottlieb and Christl concluded.
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