title: Role of public standards in the safety and efficacy of biologic medicines.
abstract: In this report, we emphasize the importance of public monographs with reference materials, coupled with careful process and change control and attention to GMPs, as a means of advancing access to good quality, safe, and effective medicines, with emphasis on available and incoming biologic medicines. With adequate control of articles covered by a monograph, these public standards can form the basis for a global public quality platform that covers reference products, non-interchangeable reference products, biosimilars, and interchangeable biosimilars. Working collaboratively with all stakeholders, new approaches allow these public standards to emerge nationally and globally in a timely way. Yet, there are increasing limitations in the availability of public standards for biologic medicines, which may reverse many decades of progress. Solutions are considered in this report.
authors.affiliation: United States Pharmacopeial Convention, 12601 Twinbrook Parkway, Rockville, Maryland, 20852, USA.
authors.forename: Roger L
authors.initials: RL
authors.lastname: Williams
authors.forename: Adrian F
authors.initials: AF
authors.lastname: Bristow
authors.forename: Walter W
authors.initials: WW
authors.lastname: Hauck
authors.forename: V Srini
authors.initials: VS
authors.lastname: Srinivasan
authors.forename: Tina
authors.initials: T
authors.lastname: Morris
authors.forename: Fouad
authors.initials: F
authors.lastname: Atouf
authors.forename: Michael
authors.initials: M
authors.lastname: Ambrose
authors.forename: Koduru V
authors.initials: KV
authors.lastname: Surendranath
authors.forename: Ranjan
authors.initials: R
authors.lastname: Chakrabarty
authors.forename: Krishna
authors.initials: K
authors.lastname: Menon
mesh_terms: D001685:Biological Factors / Q000009:adverse effects / Q000592:standards* / Q000627:therapeutic use*; D006801:Humans; D007880:Legislation, Drug; D010602:Pharmacopoeias as Topic; D012015:Reference Standards; D014481:United States
chemical_list: D001685:Biological Factors