| Autor: |
Müller-Ladner, Ulf, Hong, SeungSuh, Oh, Choongseob, Taylor, Peter |
| Předmět: |
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| Zdroj: |
Expert Review of Clinical Immunology; Sep2015 Supplement, Vol. 11, p5-14, 10p |
| Abstrakt: |
The article examines the manufacturing process for biosimilar drugs and considers the implications of any process changes. The scientific rationale behind the regulatory comparability exercise for reference medicinal products and biosimilars is also examined. CT-P13, a biosimilar of infliximab, is used as an example to discuss these issues. |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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