During the past several weeks, the FDA has issued four new guidances having to do with biosimilars.
Their intention with these four initiatives is to, "help manufacturers navigate the new terrain of biosimilar development," Leah Christl, Ph.D., FDA’s Associate Director for Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, wrote in a recent blog post on FDA Voice.
The four guidances include: Scientific Considerations in Demonstrating Biosimilarity to a Reference Product, Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product, Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009, and Biosimilars: Additional Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009.
"Having more approved biosimilars is good for public health," said Christl. "FDA looks forward to continuing to help manufacturers develop these important products."
