Abstract
Introduction: A 'biosimilar', or 'similar biological medicinal product', is a biologic agent that is similar in terms of quality, safety and efficacy to an authorized reference biological medicine. Since the expiration of the filgrastim patent in Europe, three agents have received marketing authorization from the EMA: Tevagrastim, Zarzio and Nivestim. Tevagrastim has also been approved as a biologic by the FDA as tbo-filgrastim. Areas covered: Using the EMA dossiers (all three agents), the FDA dossier (Tevagrastim), and journal publications, this article reviews clinical safety data for these products with emphasis on serious/severe adverse events and special consideration of immunogenicity, bone pain, splenomegaly, allergic reactions, acute respiratory distress syndrome and mortality. Expert opinion: All three agents have similar safety profiles. None were statistically higher on safety parameters to what is known about originator filgrastim (Neupogen). What is known about filgrastim in general regarding safety can be extended to biosimilar filgrastim. Safety profiles may become more differentiated once long-term product-specific safety data are available. Large-sample, long-term, observational studies of real-world practice will provide the heterogeneity and statistical power to demonstrate product-specific safety profiles. Current evidence indicates that statistically no one product is less and no one product is more safe.
| Original language | English (US) |
|---|---|
| Pages (from-to) | 235-246 |
| Number of pages | 12 |
| Journal | Expert Opinion on Drug Safety |
| Volume | 12 |
| Issue number | 2 |
| DOIs | |
| State | Published - Mar 2013 |
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Keywords
- Biosimilar pharmaceuticals
- Biosimilars
- Drug safety
- Granulocyte colony-stimulating factor
- Recombinant proteins
- Safety
ASJC Scopus subject areas
- Pharmacology (medical)
Cite this
Clinical safety of biosimilar recombinant human granulocyte colony-stimulating factors. / Abraham, Ivo L; Tharmarajah, Soba; Macdonald, Karen.
In: Expert Opinion on Drug Safety, Vol. 12, No. 2, 03.2013, p. 235-246.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Clinical safety of biosimilar recombinant human granulocyte colony-stimulating factors
AU - Abraham, Ivo L
AU - Tharmarajah, Soba
AU - Macdonald, Karen
PY - 2013/3
Y1 - 2013/3
N2 - Introduction: A 'biosimilar', or 'similar biological medicinal product', is a biologic agent that is similar in terms of quality, safety and efficacy to an authorized reference biological medicine. Since the expiration of the filgrastim patent in Europe, three agents have received marketing authorization from the EMA: Tevagrastim, Zarzio and Nivestim. Tevagrastim has also been approved as a biologic by the FDA as tbo-filgrastim. Areas covered: Using the EMA dossiers (all three agents), the FDA dossier (Tevagrastim), and journal publications, this article reviews clinical safety data for these products with emphasis on serious/severe adverse events and special consideration of immunogenicity, bone pain, splenomegaly, allergic reactions, acute respiratory distress syndrome and mortality. Expert opinion: All three agents have similar safety profiles. None were statistically higher on safety parameters to what is known about originator filgrastim (Neupogen). What is known about filgrastim in general regarding safety can be extended to biosimilar filgrastim. Safety profiles may become more differentiated once long-term product-specific safety data are available. Large-sample, long-term, observational studies of real-world practice will provide the heterogeneity and statistical power to demonstrate product-specific safety profiles. Current evidence indicates that statistically no one product is less and no one product is more safe.
AB - Introduction: A 'biosimilar', or 'similar biological medicinal product', is a biologic agent that is similar in terms of quality, safety and efficacy to an authorized reference biological medicine. Since the expiration of the filgrastim patent in Europe, three agents have received marketing authorization from the EMA: Tevagrastim, Zarzio and Nivestim. Tevagrastim has also been approved as a biologic by the FDA as tbo-filgrastim. Areas covered: Using the EMA dossiers (all three agents), the FDA dossier (Tevagrastim), and journal publications, this article reviews clinical safety data for these products with emphasis on serious/severe adverse events and special consideration of immunogenicity, bone pain, splenomegaly, allergic reactions, acute respiratory distress syndrome and mortality. Expert opinion: All three agents have similar safety profiles. None were statistically higher on safety parameters to what is known about originator filgrastim (Neupogen). What is known about filgrastim in general regarding safety can be extended to biosimilar filgrastim. Safety profiles may become more differentiated once long-term product-specific safety data are available. Large-sample, long-term, observational studies of real-world practice will provide the heterogeneity and statistical power to demonstrate product-specific safety profiles. Current evidence indicates that statistically no one product is less and no one product is more safe.
KW - Biosimilar pharmaceuticals
KW - Biosimilars
KW - Drug safety
KW - Granulocyte colony-stimulating factor
KW - Recombinant proteins
KW - Safety
UR - http://www.scopus.com/inward/record.url?scp=84874121792&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84874121792&partnerID=8YFLogxK
U2 - 10.1517/14740338.2013.770472
DO - 10.1517/14740338.2013.770472
M3 - Article
C2 - 23419039
AN - SCOPUS:84874121792
VL - 12
SP - 235
EP - 246
JO - Expert Opinion on Drug Safety
JF - Expert Opinion on Drug Safety
SN - 1474-0338
IS - 2
ER -