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In late April, FDA released three final guidance documents covering biosimilars. The drafts of the three were released in early 2012 as required by the 2010 Biologics Price Competition and Innovation Act (BPCIA). The first is a Q&A document covering: ● biosimilarity and interchangeability ● provisions related to requirement to submit a BLA for a “biological product,” and ● exclusivity. The second guidance covers quality considerations in demonstrating biosimilarity to a reference protein product, while the third addresses the scientific considerations. [To review IPQ’s “updates in brief” and in-depth stories on biosimilar regulatory developments around the world, click here.]
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
