title: Current regulatory and legal considerations for follow-on biologics.
authors: Covington & Burling, Washington, DC, USA. rkingham@cov.com
authors: R F
authors: RF
authors: Kingham
authors: E
authors: E
authors: Lietzan
mesh_terms: 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
chemical_list: D001688:Biological Products; D016568:Drugs, Generic