Regulatory Approach and Legal Issues of Biosimilars

Competitions and/or success in the present pharma industry is determined by the winning patent strategy which mostly pertain to the generic market entry. Generic and branded drug manufacturers both the patent strategy proximally belongs to the Hatch-Waxman Act statutory scheme and ANDA litigations. The Hatch-Waxman Act enacted in 1984 with amendment in 2003 facilitated the entry of generics at an early stage-thereby finishing the battle of branded generic ANDA of blockbuster drugs. All the same the Biologics Price Competition and Innovation (BPCI) Act has maximized the branded-generic patent duel in the biologics realm by imposing a litigated framework on follow-on-biologics. On September 16, 2011 President Obama signed the American Invents Act(AIA) of 2011 indicating a further strategy evolution of patenting branded and generics.

An FDA analysis of drug prices from 1999 to 2004 found that the discount from generic competition was just 6% with one generic competitor, but jumps to 48% with two generic competitors, 56% with three, 61% with four and 67% with five generic producers in a market. Within 2 years of the expiration of the patent of the popular drug Zantac in 1997, generics of Zantac accounted 90% of the treatment’s total sales, and the price for patients was about 10% of its pre-generic price. European patents on biologic treatments began to expire in 2000, and in April 2006, Sandoz and Biopartners successfully received EMEA approval for the first European biogenerics, two products containing human growth hormone.

  • Licensing of biosimilars
  • BLA filing for biosimilars
  • Regulatory prospects of BRIC countries
  • Biowaiver approval for biosimilars
  • Patent protection and infringement issues
  • Market exclusivities
  • Patent negotiation and litigation phase

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