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Table 3 Global regulations for the evaluation and approval of biosimilars

From: What do oncologists need to know about biosimilar products?

Feature Yes No
Own biosimilar guideline issued? EU—EMA, 2005
Australia—TGA, 2013
Malaysia—NPCB, 2008
Singapore—HSA, 2011
Japan—PMDA, 2009
South Korea—MFDS, 2010
Canada—Health Canada, 2010
US—FDA, 2015
India—Ministry of Science and Technology and Ministry of Health and Family Welfare, 2012
New Zealand—Medsafe (but refers to both EU and US guidelines)
China—CFDA (follows a simplified new product approval pathway)
Reference product must be registered in the region/country? EU
Australia
Singapore
Japan
South Korea
US
India
Canada
Malaysia (products registered in the reference countries Australia, Canada, EU, United Kingdom, France, Japan, Sweden, Switzerland, and US are considered acceptable)
Interchangeability designation? US
Singapore and Malaysia (allow if both biosimilar and reference product approved for the same indication but cannot be substituted with one another during a treatment period)
Europe
Australia
Japan
South Korea
Canada
India
Extrapolation from one indication to another? EU
Australia
Japan
South Korea
Singapore
Malaysia
Canada
US
India (allow for extrapolation of therapeutic similarity across indications in certain cases, depending on clinical experience, available literature data, and whether the same mechanisms of action or the same receptor(s) are involved in all indications)
 
  1. EU the European Union; EMA the European Medicines Agency; TGA the Therapeutic Goods Administration; CDE the Center for Drug Evaluation; NPCB the National Pharmaceutical Control Bureau; HSA the Health Sciences Authority; PMDA the Pharmaceuticals and Medical Devices Agency; MFDS the Ministry of Food and Drug Safety; US the United States; FDA the Food and Drug Administration; Medsafe the Medical Devices Safety Authority; CFDA the China Food and Drug Administration