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) |