No two classes of biosimilars: Urgent advice to the US Congress and the FDA.

Niazi, Sarfaraz K

Niazi, Sarfaraz K.

Affiliation

Niazi SK; College of Pharmacy, University of Illinois, Chicago, Illinois, USA.

J Clin Pharm Ther ; 47(9): 1352-1361, 2022 Sep.

Article in En | MEDLINE | ID: mdl-35869625

Subject(s)

Biosimilar Pharmaceuticals; Biosimilar Pharmaceuticals/adverse effects; Drug Approval/methods; Humans; United States; United States Food and Drug Administration

Key words

BPCIA; EMA; FDA; US Congress; alternating; biosimilarity; biosimilars; clinical equivalence; interchangeability; interchangeable biosimilars; substitution; switching

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biosimilar Pharmaceuticals Limits: Humans Country/Region as subject: America do norte Language: En Journal: J Clin Pharm Ther Journal subject: FARMACIA / TERAPEUTICA Year: 2022 Type: Article Affiliation country: United States

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