Regulators and manufacturers are readying for the opening of the US market, but legal wrangles continue to block the way
Stephanie Sutton |
Following the FDA’s first biosimilar approval in March, there has been a flurry of biosimilar activity in the US. First, at the end of April there was finally movement on the regulatory front, with the release of the FDA’s long-awaited final guidance on biosimilars. Two documents have been released – “Scientific Considerations in Demonstrating Biosimilarity to a Reference Product”, and “Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product”.
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