New drug approvals in US faster then in EU; imetelstat well positioned
Posted: Wed Feb 03, 2016 10:52 pm
I did a short study on the differences/similarities between drug approvals in Eu and US. I found a report (probably from 2014) that seems to provide an interesting overview.
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State of US and Europe new drug product approvals in 2013
By Olga Björklund PhD, Senior Consultant, NDA Group
Summary
Whilst there have been a number of new products approved last year, with differences between US and the EU on the number of acceptances, the actual timing was much faster in the USA, many of which had special approval status. Not surprisingly, large pharma led the way, with oncology being the most frequent, followed by CNS and endocrine products, with the EU in particular being more open to biosimilars.
full article: https://www.ndareg.com/state-us-europe- ... vals-2013/
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Another more recent article seems to underline these conclusions:
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FDA, EMA Drug Approval Stats: Are We Measuring Success The Wrong Way?
By Anna Rose Welch, Bioprocess Online, 27 March 2015
Last spring, a report by the Centre for Innovation and Regulatory Science (CIRS) highlighted the number of new drug approvals and approval times for New Molecular Entities (NMEs) being reviewed in the U.S., the EU, and Japan. According to Regulatory Affairs Professionals Society (RAPS), the EU boasted a higher number of drug approvals than the FDA in 2013 (38 NMEs vs. 27 in the U.S.). However, the FDA was quick to emphasize that, while it took Europe a median 478 days to approve a drug, the FDA’s median approval time was only 304 days in 2013.
full article: http://www.bioprocessonline.com/doc/fda ... g-way-0001
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My take:
- US has faster approvals then EU, but the EU approves more
- special approval status supports faster approval (so the ODD's for imetelstat for MF and MDS are an important pro)
- oncology drugs take the largest relative part of all approvals (imetelstat is in a good position as an anti cancer platform drug)
- large pharma are leading (Geron obviously has the right partner)
=====
State of US and Europe new drug product approvals in 2013
By Olga Björklund PhD, Senior Consultant, NDA Group
Summary
Whilst there have been a number of new products approved last year, with differences between US and the EU on the number of acceptances, the actual timing was much faster in the USA, many of which had special approval status. Not surprisingly, large pharma led the way, with oncology being the most frequent, followed by CNS and endocrine products, with the EU in particular being more open to biosimilars.
full article: https://www.ndareg.com/state-us-europe- ... vals-2013/
=====
Another more recent article seems to underline these conclusions:
=====
FDA, EMA Drug Approval Stats: Are We Measuring Success The Wrong Way?
By Anna Rose Welch, Bioprocess Online, 27 March 2015
Last spring, a report by the Centre for Innovation and Regulatory Science (CIRS) highlighted the number of new drug approvals and approval times for New Molecular Entities (NMEs) being reviewed in the U.S., the EU, and Japan. According to Regulatory Affairs Professionals Society (RAPS), the EU boasted a higher number of drug approvals than the FDA in 2013 (38 NMEs vs. 27 in the U.S.). However, the FDA was quick to emphasize that, while it took Europe a median 478 days to approve a drug, the FDA’s median approval time was only 304 days in 2013.
full article: http://www.bioprocessonline.com/doc/fda ... g-way-0001
=====
My take:
- US has faster approvals then EU, but the EU approves more
- special approval status supports faster approval (so the ODD's for imetelstat for MF and MDS are an important pro)
- oncology drugs take the largest relative part of all approvals (imetelstat is in a good position as an anti cancer platform drug)
- large pharma are leading (Geron obviously has the right partner)