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BIO 2012: Uptake of Biosimilars in Europe is Slow, Rocky

By Nuala Moran
Staff Writer

BOSTON – Mind the gap. It's not enough to chart a regulatory pathway and see biosimilar products through to approval; there remain problems with promoting uptake and delivering the promised cost savings to payers, as experience in Europe illustrates.

One of the main causes of the gap between approval and sales is explaining the concept of biosimilars to clinicians, Steffen Thirstrup of the Danish Health and Medicines Agency told delegates at BIO 2012. "The question is how many pieces are needed to get a picture of the whole. The regulators only ask for the essential parts of the puzzle, but many doctors believe we need all parts of the puzzle. That's what we are struggling with," Thirstrup said.

As an example, there is disquiet among clinicians that biosimilars do not have to go through formal Phase III trials. That has led a number of medical bodies and societies to caution against use of biosimilars, a move which Thirstrup said is due to a lack of understanding of the concept.

That and other barriers are leading to a low level of uptake. The 14 biosimilar products – versions of filgrastim (GM-CSF), somatropin (human growth hormone) and erythropoietin – approved by the European Medicines Agency between 2007 and 2010 have taken only 12 percent of the market overall.

That is a far cry from uptake rates of small-molecule generics, which typically capture 70 percent-plus of the market in the year after launch.

The issue of low uptake is exercising the European Commission, which takes great pride in having put in place the biosimilars regulatory framework and whose member countries are struggling to address the issue of rising health care costs.

One response was the formation in 2010 of a committee involving both the innovator and biosimilar sides of the industry, clinicians and patients' groups under the banner, "The Initiative on Access to Biosimilars" to investigate the reasons for low uptake."

Everyone agrees biosimilar drugs improve health care without any compromise on safety, so there is no doubt about their quality," said Thomas Heynisch of the Enterprise and Industry Directorate of the European Commission, who is managing the initiative. The commission is acting as "honest broker" to uncover the barriers so everyone can get the benefit, Heynisch told the session titled "Access to and Uptake of Biosimilars: The European Experience."

Removing barriers is important in increasing familiarity and driving adoption of existing biosimilars, but it will be even more significant as higher-cost monoclonal antibody drugs begin to come off patent in Europe in 2012 and 2013. Only €1.04 billion (US$1.31 billion) of total EU annual spending on biologics of €30 billion is open to biosimilar competition currently, and the expected wave of biosimilar MAb approvals could deliver far greater cost savings for payers.

The mission to improve market access is taking on a different complexion now that so many biotech innovators have announced plans to move into biosimilars, acknowledged Thomas Bols, of Merck Serono SA, who represents the innovator companies on the Initiative to Access Biosimilars committee.

"I feel like a Toyota dealer discussing how to increase the market share of Ford," he said.

With or without high levels of uptake, the arrival of biosimilars is pushing down the price of reference products, Bols noted. "So you don't need a lot of biosimilars on the market to make savings – which is what matters from a payer's perspective."

One of the other reasons for the slow development of the market is that companies used small-molecule generics as their business model, whereas it is now clear that biosimilars have more in common with innovator drugs, with a need for medical education and direct engagement with physicians.

Reimbursement agencies also have slowed things down, because they took time to get to grips with biosimilars, having no previous experience of negotiating prices on a new class of drugs that was not novel.

But perhaps the biggest difference between small-molecule generics and biosimilars, and the factor that has caused the greatest barrier in terms of market access, is that no automatic substitution is allowed in the pharmacy.

That makes the provision of an independent source of advice for clinicians extremely important, said Paul Greenland, head of biosimilars at Hospira Inc., and a representative of the industry body, the European Generic Association.

"In most cases, biosimilars can only be used if the physician agrees, and this can be difficult to achieve," Greenland said.

The Initiative on Access to Biosimilars is now three-quarters of the way through drawing up a document agreed on by industry, clinicians and payers, to provide unbiased information on biosimilars, which Greenland said will help overcome unfavorable perceptions.

All of that carries important lessons for the U.S. as the biosimilars markets begin to develop Bols contended. "Europe has blazed a trail, so the delays around perception, and so on, will be out of the way when we see the first biosimilars on the market in the U.S., and companies can build on the European experience."