225 related articles for article (PubMed ID: 21784654)
1. A biosimilar industry view on the implementation of the WHO guidelines on evaluating similar biotherapeutic products.
Schiestl M
Biologicals; 2011 Sep; 39(5):297-9. PubMed ID: 21784654
[TBL] [Abstract][Full Text] [Related]
2. Clinical programs in the development of similar biotherapeutic products: rationale and general principles.
Berghout A
Biologicals; 2011 Sep; 39(5):293-6. PubMed ID: 21911300
[TBL] [Abstract][Full Text] [Related]
3. Current regulatory and scientific considerations for approving biosimilars in Iran.
Hadavand N; Valadkhani M; Zarbakhsh A
Biologicals; 2011 Sep; 39(5):325-7. PubMed ID: 21873077
[TBL] [Abstract][Full Text] [Related]
4. WHO/KFDA joint workshop on implementing WHO guidelines on evaluating similar biotherapeutic products, Seoul, Republic of Korea 24-26 August, 2010.
Wadhwa M; Kang HN; Knezevic I; Thorpe R; Griffiths E
Biologicals; 2011 Sep; 39(5):349-57. PubMed ID: 21906959
[TBL] [Abstract][Full Text] [Related]
5. Regulatory guideline for biosimilar products in Korea.
Suh SK; Park Y
Biologicals; 2011 Sep; 39(5):336-8. PubMed ID: 21784653
[TBL] [Abstract][Full Text] [Related]
6. Concept of biosimilar products in Jordan.
Haddadin RD
Biologicals; 2011 Sep; 39(5):333-5. PubMed ID: 21873079
[TBL] [Abstract][Full Text] [Related]
7. Summary of the diverse situation of similar biotherapeutic products in the selected countries (August 2010).
Kang HN
Biologicals; 2011 Sep; 39(5):304-7. PubMed ID: 21880507
[TBL] [Abstract][Full Text] [Related]
8. Biosimilars: impact of biologic product life cycle and European experience on the regulatory trajectory in the United States.
Ahmed I; Kaspar B; Sharma U
Clin Ther; 2012 Feb; 34(2):400-19. PubMed ID: 22244050
[TBL] [Abstract][Full Text] [Related]
9. Regulatory guidelines for biosimilars in Malaysia.
Abas A
Biologicals; 2011 Sep; 39(5):339-42. PubMed ID: 21784655
[TBL] [Abstract][Full Text] [Related]
10. Industry views of biosimilar development in Japan.
Horikawa H; Tsubouchi M; Kawakami K
Health Policy; 2009 Jul; 91(2):189-94. PubMed ID: 19157628
[TBL] [Abstract][Full Text] [Related]
11. Evaluation of similar biotherapeutic products (SBPs): scientific principles and their implementation.
Knezevic I
Biologicals; 2011 Sep; 39(5):256-61. PubMed ID: 21907589
[TBL] [Abstract][Full Text] [Related]
12. Biosimilars and non-innovator biotherapeutics in India: an overview of the current situation.
Malhotra H
Biologicals; 2011 Sep; 39(5):321-4. PubMed ID: 21784652
[TBL] [Abstract][Full Text] [Related]
13. Biosimilars--global issues, national solutions.
Knezevic I; Griffiths E
Biologicals; 2011 Sep; 39(5):252-5. PubMed ID: 21924623
[TBL] [Abstract][Full Text] [Related]
14. Current development in regulation of similar biotherapeutic products in Brazil.
Castanheira LG; Barbano DB; Rech N
Biologicals; 2011 Sep; 39(5):308-11. PubMed ID: 21868247
[TBL] [Abstract][Full Text] [Related]
15. The regulatory framework for similar biotherapeutic products in Cuba.
Hechavarría Núñez Y; Pérez Massipe RO; Orta Hernández SD; Muñoz LM; Jacobo Casanueva OL; Pérez Rodríguez V; Domínguez Morales RB; Pérez Cristiá RB
Biologicals; 2011 Sep; 39(5):317-20. PubMed ID: 21930393
[TBL] [Abstract][Full Text] [Related]
16. Registration of similar biological products--Singapore's approach.
Poh J; Tam KT
Biologicals; 2011 Sep; 39(5):343-5. PubMed ID: 21783381
[TBL] [Abstract][Full Text] [Related]
17. The challenges of immunogenicity in developing biosimilar products.
Wadhwa M; Thorpe R
IDrugs; 2009 Jul; 12(7):440-4. PubMed ID: 19579165
[TBL] [Abstract][Full Text] [Related]
18. Recommendations regarding technical standards for follow-on biologics: comparability, similarity, interchangeability.
Davis GC; Beals JM; Johnson C; Mayer MH; Meiklejohn BI; Mitlak BH; Roth JL; Towns JK; Veenhuizen M
Curr Med Res Opin; 2009 Jul; 25(7):1655-61. PubMed ID: 19476407
[TBL] [Abstract][Full Text] [Related]
19. WHO standards for biotherapeutics, including biosimilars: an example of the evaluation of complex biological products.
Knezevic I; Griffiths E
Ann N Y Acad Sci; 2017 Nov; 1407(1):5-16. PubMed ID: 28905423
[TBL] [Abstract][Full Text] [Related]
20. Biosimilars clinical development program: confirmatory clinical trials: a virtual/simulated case study comparing equivalence and non-inferiority approaches.
Fletcher MP
Biologicals; 2011 Sep; 39(5):270-7. PubMed ID: 21875812
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
