Current regulatory and legal considerations for follow-on biologics.
Kingham
R F
RF
Covington & Burling, Washington, DC, USA. rkingham@cov.com
Lietzan
E
E
D001688:Biological Products / Q000009:adverse effects / Q000592:standards*; D001709:Biotechnology / Q000331:legislation & jurisprudence* / Q000639:trends; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D016568:Drugs, Generic / Q000009:adverse effects / Q000592:standards*; D005062:European Union; D006801:Humans; D011640:Public Policy; D013678:Technology, Pharmaceutical / Q000331:legislation & jurisprudence* / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration / Q000331:legislation & jurisprudence / Q000592:standards
D001688:Biological Products; D016568:Drugs, Generic