Regulatory Approach for Biosimilars

An FDA analysis of drug prices from 1999 to 2004 found that the discount from generic competition was just 6 percent with one generic competitor, but jumps to 48 percent with two generic competitors, 56 percent with three, 61 percent with four and 67 percent with five generic producers in a market. Within two years of the expiration of the patent for the popular drug Zantac in mid-1997, generic versions accounted for 90 percent of the treatment’s total sales, and the price for patients was about 10 percent of its pre-generic price. European patents on biologic treatments began to expire in 2000, and in April 2006, Sandoz and Biopartners received EMEA approval for the first European Biogenerics, two products containing human growth hormone.

 

  • Biosimilars regulation
  • Biosimilars regulation
  • BLA filing for Biosimilars
  • Regulatory prospects of BRIC countries
  • Aparadigm of traditional generics to Biosimilars
  • Biowaiver approval for Biosimilars
  • Generic Biosimilars
  • Regulatory Prospects in BRIC countries

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