Assessing the Impact of a Safe and Equitable Biosimilar Policy in the United States: Hearing Before the Subcommittee on Health of the Committee on Energy and Commerce, House of Representatives, One Hundred Tenth Congress, First Session, May 2, 2007, Volume 4
U.S. Government Printing Office, Jan 1, 2008 - Biologicals - 184 pages
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abbreviated affordable allow amino acid application assessment Avastin Barr Pharmaceuticals bill billion biogenerics biologic drug biologic products biopharmaceuticals biosimilars biotech biotech drugs biotechnology brand company brand product BURGESS CalPERS Chairman children with cancer clinical studies clinical testing clinical trials Committee comparability competition complex cost data exclusivity determine disease ensure ESHOO Express Scripts FD&C Act FDA's follow-on biologics follow-on product follow-on protein products formulary Genentech Hatch-Waxman Act healthcare hearing Herceptin human growth hormone hyaluronidase immunogenicity important incentives industry innovator product INSLEE Insmed interchangeable issue KINGHAM legislation manufacturing changes manufacturing process Omnitrope opening statement PALLONE pathway for follow-on patient safety percent pharmaceutical pharmacokinetic physician post-marketing potential prepared statement prescription drugs questions recombinant reference products regulatory require safe safety and effectiveness safety and efficacy savings SCHENKEIN scientific small molecule Subcommittee on Health testimony Thank therapeutic therapies treatment versions Waxman WOODCOCK