Biosimilars [Design Issues]

posted by drgunasakaran1  – 2012-02-06 14:57 (4019 d 07:09 ago) – Posting: # 8059
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❝ […] kindly explain me can i enroll healthy subjects for biosimilars BA/BE study ?


Dear Mr.Vasu,

You can enroll healthy volunteers in the Pharmacokinetic studies required for Biosimilars like Interferon alpha See section 5 Clinical Studies (Page 5 of 7).

Efficacy and safety studies of Biosimilars will be done in patient population.

Kindly go through EMA's Product Specific Biosimilar Guidances.



Edit: Full quote removed. Please delete anything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Helmut]

Dr S Gunasakaran MBBS MD
Disclaimer: The replies/posts are my personal opinions and it does not represent my company views on the same.

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