Regulatory stratergies for biosimilars in regulated and emerging markets

Pharma Times

Volumn 45, Issue 1, 2013, Pages 11-14

  Reddy, Soundarya ^a   Balamuralidhara, V ^a   Pramod Kumar, T M ^a   Teja, C H ^a   Reddy, Shreekanth ^a  

^a JSS COLLEGE OF PHARMACY   (India)

Author keywords

[No Author keywords available]

Indexed keywords

BIOSIMILAR AGENT; GENERIC DRUG;

ARTICLE; CHINA; DRUG APPROVAL; DRUG CONTROL; DRUG EFFICACY; DRUG FORMULATION; DRUG INDUSTRY; DRUG INFORMATION; DRUG LEGISLATION; DRUG MANUFACTURE; DRUG MARKETING; DRUG SAFETY; EUROPEAN UNION; GOVERNMENT REGULATION; INCOME; INDIA; JAPAN; PRACTICE GUIDELINE; PROGRAM DEVELOPMENT; RUSSIAN FEDERATION; SOUTH KOREA; STRATEGIC PLANNING; UNITED STATES;

EID: 84873849289     PISSN: 00316849     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Article

References (18)

1. http://www.bccresearch.com/pressroom/report/code/BIO090A/Global Markets
2. http://www.gabionline.net/Biosimilars/Research/US-54-billion-worth-of-biosimilar-patents-expiring-before-2020
3. http://www.gabionline.net/Reports/WHO-guidelines-on-biosimilars-case-studies-and-discussion-highlights
4. http://www.who.int/medicines/areas/quality_safety/regulation_legislation/icdra/PL5-2.pdf
5. http://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
6. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp&mid=WC0b01ac058002958c
7. http://www.gabionline.net/Reports/Biosimilars-marketed-in-Europe
8. http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003517.pd
9. https://www.pharmatching.com/inforena/pharma-outsourcing-practice-biosimilars-guidelines-players
10. http://www.google.co.in/#hl=en&spell=1&q=Recent+Regulations+of+Biosimilars+in+Japan&sa=X&ei=o3NULe5FsztrQe_yoGQDQ&ved=0CBwQvwUoAA&bav=on.2,or.r_gc.r_pw.r_qf.&fp
11. http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/default.htm
12. http://www.pmda.go.jp/regulatory/file/english_presentation/biologics/B-E1arato.pdf
13. http://www.novartis.com/downloads/investors/shareholders-information/Investor-Insights-2.pdf
14. http://www.biosimilars.ca/docs/Evalutation_Guidelines_for_Biosimilars.pdf
15. http://www.expresspharmaonline.com/20120215/market04.shtml
16. http://www.apecahc.org/images/training/20120412/[Presentation]%2012_Yi%20Chu%20Lin.pdf
17. http://www.ibef.org/download/Biosimilars-in-India-30312.pdf
18. http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2011/06/WC500107831.pdf