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Biogeneric
(redirected from Biosimilar)

   Also found in: Wikipedia 0.03 sec.
Biogeneric
A biopharmaceutical or other biological product—e.g., insulin, hGH—that has emerged from patent protection and can be manufactured by a party other than the original developer using either identical or different manufacturing processes; for FDA approval, the product must be bioequivalent or comparable to the original innovative product


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The establishment of a production capability outside of the United States is an important step in GTC's long term biosimilar strategy, the company said in a statement.
Topics covered in the white paper include: patent expiries and anticipated biosimilar entry dates for key biologic brands; companies at risk from biosimilars; and who the key competitors will be in the biosimilars market.
European officials have already given approval to biosimilar forms of an anaemia drug and human growth hormone.
 
 
 
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