Lead markets: A European success story – Biosimilars

This article is taken from the new Science|Business report, “Innovation – The Demand Side”

In normal circumstances, pharmaceutical and biotech companies in Europe find themselves at a disadvantage compared with the US. Despite the lofty ideals and practical efforts of EMEA, the European drugs regulator, the market remains fragmented both in terms of the rules and conditions that govern drug development and the post-registration hurdles that must be jumped to agree reimbursement.

But in one shining area of healthcare, Europe has outpaced the US in creating a new sector: biosimilars. These are bio-engineered copies of original biological (protein) drugs that are coming off patent. EMEA has poured great effort into devising a pan-European framework for approving them.

The framework recognises that, unlike small-molecule drugs (what’s mostly inside your medicine cabinet), the properties of high-tech biologicals are as intimately tied to their manufacturing process as they are to their chemical composition. This is acknowledged by substituting the term biosimilar for biogeneric.

This did not happen overnight – but after a five-year consultation period Europe opened the floodgates to generic biopharmaceuticals in January 2006, agreeing that the human growth hormone Omnitrope, manufactured by Germany’s Sandoz GmbH, is equivalent in quality, safety and efficacy, to the original registered product. Following on from this decision EMEA was expecting eight applications to register biogenerics in 2006. Biopharmaceuticals with global sales of more than $10 billion per annum will come off patent by 2007, and the move is also expected to contribute to cost savings in health care.

The move by EMEA left its US counterpart, the Food and Drug Administration, trailing, though following the Democrats’ electoral successes in November 2006, there is renewed pressure for an approval route for biogenerics.

The US pioneers of the biotech industry have fought hard against the approval of biogenerics both in the US and Europe, claiming biopharmaceuticals cannot be copied in the same way as chemical drugs.

It was only by conceding exact copies are impossible and making this explicit by ditching the term biogeneric in favour of biosimilar that EMEA was able to make progress.

While the requirements for registering a biosimilar are more complex and costly than for conventional generic medicines, they are not as exacting as the route to market for the original product.

Having taken a lead over the US in framing the regulatory framework and granting the first approvals, it is now open to the EU to capitalise on the market – thus cutting its own healthcare costs, and giving European firms a competitive edge.