POLICY & REGULATION
INEXACT COPIES: Biosimilars have started to gain recognition,
yet some innovators are still trying to portray them as less safe or
effective than reference products
Biosimilars regulation fi nds its feet
Progress with new biosimilars legislation was slow in 2008, and the EU remains the only market with a
dedicated pathway. However, the new political scene in the all-important US market could well speed
things up in 2009, says Ian Schofi eld
A
fter a promising start, the European approval pathway in place since 2005, substance, partly because the originators have
biosimilars segment lost momentum supported by a range of regulatory and come up with advanced delivery systems, and
in 2008, with just one substance – product-specifi c guidelines.
partly because insulin analogues are now taking
G-CSF for chemotherapy-induced neutropenia Nonetheless, so far biosimilar versions
over from standard insulin.
– receiving marketing approval from the of just three substances – human growth
Biosimilar versions of more complex
European Commission. hormone, EPO and G-CSF – have been
compounds, such as monoclonal antibodies,
Things are likely to look up over the coming approved for marketing in Europe, albeit
may also face substantial scientifi c hurdles
years as companies and regulators gain more from various companies under a range of
when it comes to showing their similarity to
experience in biosimilar development and brand names.
existing products.
evaluation, and more biotech drugs come Other products have hit problems.
But the EMEA is pressing on, and has been
off patent. But given the scientifi c challenges Alpheon, an interferon alfa-2a product for
drafting new guidelines as well as updating old
presented by increasingly complex biotech hepatitis C from BioPartners, was rejected by
ones. A guideline on biosimilar low molecular
products, progress may well be on the the European Medicines Agency’s scientifi c
weight heparins was released for consultation
slow side. committee, the CHMP, in mid-2006, over
Moreover, the EU is still alone in having a quality, safety and effi cacy concerns.
in April 2008, and the current guidance on
dedicated regulatory pathway for biosimilars, And at the beginning of 2008, Marvel
interferon alfa is being reviewed in light of new
so companies working in this sector do not yet LifeSciences withdrew its application for a
scientifi c knowledge.
have a global marketplace for their products. biosimilar version of Lilly’s insulin product,
The agency itself believes progress will be
The US failed to pass legislation in 2008, and Humulin, after the company was refused extra
fairly slow in the near future. “We don’t expect
while Japan and Canada are both working on time to answer questions posed by the CHMP.
so many applications in the coming years,
systems for approving biosimilars, few concrete Insulin poses a particular challenge for
maybe fi ve or six, or even less than this,” EMEA
results have emerged so far. biosimilar fi rms. There is an EMEA guideline in
executive director Thomas Lönngren told Scrip.
The EU can pride itself on having led place on biosimilar insulin, dating from 2006, “There were a lot in the beginning, [but] now
the way in this fi eld. It has had a biosimilars but few fi rms are thought to be developing the it has stabilised at a lower level.”
www.scripnews.com/supplements Scrip 100
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