A biosimilar industry view on the implementation of the WHO guidelines on evaluating similar biotherapeutic products

Biologicals

Volumn 39, Issue 5, 2011, Pages 297-299

  Schiestl, Martin ^a,b  

^a IGPA International GenericPharmaceutical Alliance ^*  (Canada)

^b NOVARTIS PHARMA AG   (Switzerland)

Author keywords

Biosimilar; Similar biotherapeutic products

Indexed keywords

BIOLOGICAL PRODUCT; ERYTHROPOIETIN; GENERIC DRUG; SIMILAR BIOTHERAPEUTIC PRODUCT; UNCLASSIFIED DRUG;

ARTICLE; DRUG APPROVAL; DRUG EFFICACY; DRUG INDUSTRY; DRUG MANUFACTURE; DRUG QUALITY; DRUG SAFETY; DRUG SCREENING; LICENSING; PRIORITY JOURNAL; STANDARD; WORLD HEALTH ORGANIZATION;

DRUG EVALUATION; DRUG INDUSTRY; GUIDELINES AS TOPIC; RECOMBINANT PROTEINS; WORLD HEALTH ORGANIZATION;

EID: 80053568475     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2011.06.014     Document Type: Article

References (9)

1. EMA. Guideline on similar biological medicinal products-CHMP/437/04; 2005.
2. EMA. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: quality issues-EMEA/CHMP/BWP/49348/2005; 2006.
3. EMA. Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues-EMEA/CHMP/BMWP/42832/2005; 2006.
4. WHO. Guidelines on evaluation of similar biotherapeutic products (SBP), WHO ECBS 60th 2009.
5. ICH Q8(R2). Pharmaceutical development; 2009.
6. ICH Q9. Quality risk management; 2005.
7. ICH Q10. Pharmaceutical quality system; 2008.
8. Chirino A.J., Mire-Sluis A. Characterizing biological products and assessing comparability following manufacturing changes. Nat Biotechnol 2004, 22:1383-1391.
9. ICH Q5E. Comparability of biotechnological/biological products subject to changes in their manufacturing process; 2004.