FDA. Information on biosimilars.
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/
approvalapplications/therapeuticbiologicapplications/biosimilars/default.htm

FDA. Information for Healthcare Professionals (Biosimilars).
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/
approvalapplications/therapeuticbiologicapplications/biosimilars/ucm241719.htm

FDA. Biosimilar Guidances.
http://www.fda.gov/drugs/guidancecomplianceregulatoryinformation/guidances/ucm290967.htm

FDA. Guidance for Industry.
Q5E Comparability of biotechnological/biological products subject to changes in their manufacturing process.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/
Guidances/ucm073476.pdf

FDA. Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.
http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/
approvalapplications/therapeuticbiologicapplications/biosimilars/ucm411418.htm

National Conference of State Legislatures.
State Laws and Legislation Related to Biologic Medications and Substitution of Biosimilars.
http://www.ncsl.org/research/health/state-laws-and-legislation-related-to-biologic-medications-and-substitution-of-biosimilars.aspx

EMA. Overarching Biosimilar Guidelines.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000408.jsp

Access other Therapeutic Areas:


 

New & Noteworthy