'Follow-on biologics': ensuring continued innovation in the biotechnology industry.
Congress adopted legislation in 1984 to encourage pharmaceutical companies to develop new drugs, while simultaneously allowing competitors to bring cheaper generic versions to market. More than twenty years later, Congress may be faced with a similar balancing act for biologics. When Congress takes up this issue, it must focus on the substantial differences that exist between biologics and drugs. It should also evaluate the patent law, which is yielding increasingly narrow patents. If additional measures are not adopted in light of the intersection of these factors, then any legislation allowing for "follow-on" biologics could stifle development of new medicines from biotechnology.
Manheim
Bruce S
BS
Life Sciences Group at the law firm Ropes and Gray LLP in Washington, DC, USA. bruce.manheim@ropesgray.com
Granahan
Patricia
P
Dow
Kenneth J
KJ
D001688:Biological Products / Q000191:economics* / Q000600:supply & distribution; D001709:Biotechnology / Q000191:economics* / Q000331:legislation & jurisprudence; D004059:Diffusion of Innovation; D004345:Drug Industry / Q000331:legislation & jurisprudence*; D016568:Drugs, Generic / Q000600:supply & distribution; D006801:Humans; D010330:Patents as Topic / Q000331:legislation & jurisprudence; D012106:Research; D014481:United States
D001688:Biological Products; D016568:Drugs, Generic