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« Amicus Briefs in Ariad v. Lilly: Federal Circuit Bar Association | Main | Amicus Briefs in Ariad v. Lilly: American Intellectual Property Law Association »

November 30, 2009

Comments

Don,

Those who whine about the 12 year data exclusivity being "too long" for biosimilars won't acknowledge that now there isn't any pathway, so some pathway is better than no pathway. Even Europe recognized the need for a longer pathway for biosimilars after the "pure red cell" tragedy in 2001. And if 12 years of data exclusivity is "too long," biosimilars can still choose to start their own NDA process.

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