The full version of this biosimilars feature can be read in the August issue of our digital magazine: http://www.pharmtech.com/ptedigital0810
Ameet Malik
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Biologics account for 10 to 15% of total global drug expenditure and approximately one-third of the global pharma development
pipeline. In light of the impressive size and predicted growth of this market, there has been a rising interest in the development
of biosimilars. We believe that all stakeholders are increasingly realising that marketed biosimilars offer comparable quality,
safety and efficacy to their reference products. Indeed, this is the basis on which they were approved by the centralised
European procedure. To quote Nicolas Rossignol, the (former) EC pharma division administrator: "We are confident that if a
product meets all the requirements and gets a marketing authorisation from the Commission, it means that the product is as
safe and effective as any other product authorised by the Commission."
This is a new industry, so there may still be a tendency in some cases to be cautious. This will only improve with time; firstly,
the importance of biopharmaceuticals will continue to increase, with growing and ageing populations increasingly prone to
difficult-to-treat diseases ranging from cancer to autoimmune disorders. Secondly, while demand will drive overall costs steadily
higher, medicines with an estimated market value of +$60 billion are set to lose patent protection through 2015, paving the
way for the biosimilars market to really take off.
In the meantime, we are seeing the understanding of the "biosimilar concept" steadily increasing among key stakeholders, as
well growing awareness that high-quality, clinically proven biosimilars really can play a significant role in helping to ensure
access to essential biopharmaceuticals at times of increasing cost pressures. This parallel trend — towards more rigorous
cost-benefit analysis and a broader definition of therapeutic alternatives — is reflected in two recent landmark decisions
by the UK's National Institutes of Clincal Excellence (NICE):
The decision to recommend the use of Omnitrope biosimilar on the same basis as six other human growth hormone products — the
first such decision involving a biosimilar.
The decision not to recommend the use of Herceptin for the treatment of gastric cancer, on cost-benefit grounds.
In parallel, we see that anti-biosimilar campaigns by certain interested parties are beginning to "lose their bite". There
is also growing understanding of the fact that biopharmaceutical originator companies also effectively create changes in their
products similar to "biosimilars" when they modify their original manufacturing processes.
Labelling and safety
Biosimilars are biopharmaceuticals approved by the centralised European biosimilar regulatory pathway. This explicitly recognises
that existing biosimilars can and should have the same INN (International Non-Proprietary Name) as their reference product.
Reference products that change through major manufacturing or process modifications also have the same INN. Based on the science,
the same principle should also apply to future biosimilar products including monoclonal antibodies, as well as, manufacturing
changes to originator products. Provided that the mechanism of action is equivalent for all indications, biosimilars should
also be approved in the same indications as the reference product.
With reference to post-approval safety studies, these are an integral requirement of marketing authorisations for all biopharmaceutical
products. Biosimilars are, and should be, treated in this respect on exactly the same basis as their reference products. The
same principle applies to additional regulatory approvals. The biosimilar applicant should work with the regulatory authorities
on a case-by-case basis to define the nature and extent of clinical data requirements.
