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Dear All,
I would like to know about the guidance or criteria of biological
products such as recombinant eryhtropoietin or recombinant insulin
since many products is now available on the market. In order to ensure
the efficacy of these products whether it is similar to the original
products. What should we do?
Best Regards,
Wichittra
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The following message was posted to: PharmPK
Wichittra,
The European Medicines Agency (EMEA) have published several guidelines
for biosimilar products such as insulin and erythropoietin which can
be located at the followings:
http://www.emea.europa.eu/pdfs/human/pcwp/7456206en.pdf
http://www.emea.europa.eu/pdfs/human/biosimilar/3277505en.pdf
http://www.emea.europa.eu/pdfs/human/biosimilar/9452605en.pdf
http://www.tga.gov.au/DOCS/pdf/euguide/bmwp/9452805en.pdf
Best wishes,
Khalid Alkharfy
College of Pharmacy
King Saud University
Riyadh, Saudi Arabia
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The following message was posted to: PharmPK
The standard requirements for bioequivalence can be found, since
these are
large biological molecules, you will need to establish that your
product has
the same antigencity profile (or better) than the original.
Edward F. O'Connor, PhD
78 Marbern Drive
Suffield, CT 06078
efoconnor.aaa.cox.net
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