Biosimilars, generic versions of the first generation of therapeutic proteins: do they exist?
This contribution describes the present regulatory status in the EU of biosimilars, the generic versions of the first generation of therapeutic proteins. It points out why and where recombinant protein molecules and low-molecular-weight drugs differ in their behaviour and why biosimilars should be handled differently than generic low-molecular-weight drugs. This information is important for practitioners (pharmacists and physicians) while selecting the best supplier of a therapeutic protein.
Crommelin
Daan
D
Faculty of Pharmaceutical Sciences, Utrecht University, Utrecht, The Netherlands.
Bermejo
Theresa
T
Bissig
Marco
M
Damiaans
Jaak
J
Krämer
Irene
I
Rambourg
Patrick
P
Scroccaro
Giovanna
G
Strukelj
Borut
B
Tredree
Roger
R
Ronco
Claudio
C
D000917:Antibody Formation; D001702:Biopharmaceutics / Q000331:legislation & jurisprudence; D004355:Drug Stability; D016568:Drugs, Generic / Q000737:chemistry; D006801:Humans; D015394:Molecular Structure; D008970:Molecular Weight; D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins / Q000737:chemistry*
D016568:Drugs, Generic; D004364:Pharmaceutical Preparations; D011994:Recombinant Proteins