The first budget of US President Barack Obama has called for Congress to establish a workable regulatory, scientific and legal pathway for the approval of "generic" biologics. Although the budget uses the term "generic" biologics, it likely refers to the creation of an approval pathway for follow-on-biologics, which in Canada are called subsequent entry biologics (SEBs) and in the EU are called biosimilars, neither being true generics (that is, not being truly interchangeable products).
Shortly after the release of the US budget, the Canadian Generic Pharmaceutical Association (CGPA) made a plea to the Canadian Government to follow suit. In 2008, Health Canada released a draft guidance addressing the submission requirements for SEBs, stating that an approval pathway would be developed and that, in the meantime, the current regulatory framework could accommodate the approval of SEBs (see "Health Canada Releases Draft Guidance on Subsequent Entry Biologics
" E-TIPS®, Vol 6, No 20, April 9, 2008). A final guidance document from Health Canada is expected shortly.
Both the US and Canada have lagged behind the EU, which established an approval pathway for biosimilars in 2004. Since then, there have been a number of biosimilar approvals in the EU, including the approval last month for Sandoz's granulocyte colony stimulating factor (G-CSF) product, which referenced Amgen's NEUPOGEN.
For Commentary, see:
For the CPGA press release, visit:
For the Sandoz press release, see:
Summary by: Michael Migus