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The new generic

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It could be as commonplace a wordin the pharmacy lexicon as ‘generic' if the regulators get their policiesright.  Biosimilars are to biologicaldrugs what generics are to small molecule drugs - clinically equivalentalternatives at reduced cost.

Many expect the future market forbiosimilars to be in the multi-billion dollar range.  Whilst biological drugs currently account foronly approximately 20% of global drug sales this is expected to grow at doubledigit rates, especially as the use of conventional drugs declines and patentexpirations come closer.  Biosimilars arein an ideal position to take advantage of this growth.

Unlike generics, biosimilars arenever exact bioequivalent copies of their original.  The complexity of biological drugs, with theirintricate structures and complicated manufacturing processes, makes them nearlyimpossible to replicate exactly.  Thiscan result in differing therapeutic effects.

This has been a tricky issue formedicine regulators who have to decide when a copy is good enough to beconsidered equal to the real thing.  Ifthe market is to really take off there needs to be a shortcut for biosimilarmanufacturers so that extensive, expensive clinical trials needn't be conductedon drugs that are practically identical to existing ones.

The EU has been ahead of the FDAon this issue having released a framework for approving biosimilars in2004.  These require clinical tests forbiosimilars but the extent and nature of the tests depends on the class of thedrug being copied.  The more complicatedthe class, the more testing required. It's thought that the FDA will follow suit with a similar framework verysoon thus opening the US market which should fuel further growth.

Current biosimilars have focussedon some of the simpler biological drugs to manufacture such as human growth hormoneand erythropoietin.  The future isthought to lie in creating copies of monoclonal antibodies which account forconsiderably greater sales.  They are,however, a lot more complicated and therefore expensive to manufacture.

Typically a generic may cost afew million dollars to develop whereas biosimilars will cost around$100-150m.  This acts as a greaterbarrier to entry and means there is reduced potential for price markdown.  Savings of around 90% are seen ongenerics.  It is expected that savingswill be in the order of 20-30% for biosimilars.

The current biotech heavy-weightswill no doubt fight hard against anything that makes things easier forbiosimilar manufacturers.  Assuming thisissue, and the difficulties regulators face on ensuring reproducibility andsafety, can be overcome I think we'll be seeing a lot more biosimilars infuture.

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