Posted: December 2nd, 2013
Technical & Regulatory Issues Related to the Creation & Approval of Biosimilars
Project description
Discuss the technical and regulatory issues related to creation and approval of Biosimilars. Your discussion must include:
1. Detailed discussion of scientific difficulties of creating biosimilars
2. Discussion of why this creates regulatory issues, and how the US FDA is approaching the issue of biosimilars, in comparison to how the European Medicines Agency (EMEA is approaching biosimilars
3. analysis of the technical and regulatory aspects of the FDA’s approval of a Momenta Pharmaceutical and Sandoz’s biosimilar version of Lovenox(enoxaparin sodium) in August 2010 and
4) your opinion of whether the FDA is taking the right approach in comparison to how the EMEA is handling the same issue (who is tackling the problem better.
Discuss the technical and regulatory issues related to creation and approval of Biosimilars. Your discussion must include:
1. Detailed discussion of scientific difficulties of creating biosimilars
2. Discussion of why this creates regulatory issues, and how the US FDA is approaching the issue of biosimilars, in comparison to how the European Medicines Agency (EMEA is approaching biosimilars
3. analysis of the technical and regulatory aspects of the FDA’s approval of a Momenta Pharmaceutical and Sandoz’s biosimilar version of Lovenox(enoxaparin sodium) in August 2010 and
4) your opinion of whether the FDA is taking the right approach in comparison to how the EMEA is handling the same issue (who is tackling the problem better.
**Paper must be APA format and 12 pages long including a abstract, intro, body and reference. There MUST be citations included in APA format as well.
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