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BioSimilar
Biosimilar Price Competition and Innovation Act – Discussions on the…
Now that the Affordable Care Act (ACA) was mostly upheld by the United States Supreme Court, one of the major provisions—the…
FDA Draft Guidance on BioSimilars – Key Responses
Earlier this year, the Food and Drug Administration (FDA) issued three draft guidance documents on biosimilar product development…
FDA Clarifies the Three Biosimilars Draft Guidance’s
The Food and Drug Administration (FDA) presented an educational webinar on biosimilars, and provided an overview of the law, the…