Europe ready to embrace first copies of biotech cancer drugs

Treatment with two important cancer drugs is about to get much cheaper in Europe with a cut-price copy of Roche’s blood cancer drug Rituxan likely to hit the market imminently followed by a rival to its breast cancer medicine Herceptin. As cancer drug prices spiral, the arrival of the first biosimilars or copies of biotech drugs, ones made inside living cells, puts European oncologists in the forefront of a treatment shift that could slash costs and expand patient access. Copycat versions of Rituxan, also known as MabThera, and Herceptin have faced several delays in development in the past.

This time the world’s biggest cancer drugmaker cannot escape the competition. Approval from the pan-European regulator, the European Medicines Agency (EMA), is pending and preparations are under way for the launch of a Rituxan biosimilar from South Korea’s Celltrion. “We’re expecting it to be available shortly,” Andrew Roberts of Napp Pharmaceuticals, which will sell the intravenous drug in Britain, told Reuters. The EMA does not comment on upcoming approvals but its website shows it is assessing two biosimilar versions of Rituxan and three of Herceptin. Industry analysts believe Mylan and its partner Biocon may win a green light for the first Herceptin biosimilar in Europe later this year. Big numbers are at stake. Rituxan sold $7.3 billion worldwide last year, while Herceptin brought in $6.75 billion. Although copies of both are sold in parts of Asia, Europe is the first large market, with US launches still some way off. Investors have been concerned about how quickly doctors would trust the new drugs but cancer experts and healthcare providers, worried about the finances of Europe’s healthcare system, say they plan to embrace the cut-price medicines.

Oncologists see savings creating financial headroom for a new wave of even more expensive immunotherapy drugs that are revolutionizing cancer care but can cost more than $100,000 per patient. “Whether it’s in the public or the private sector, we need to provide sustainable healthcare and biosimilars are clearly a good way to improve affordability,” said Josep Tabernero, head of medical oncology at the Vall d’Hebron University Hospital in Barcelona.

Tabernero believes uptake will be just as good as for biosimilar rheumatoid arthritis drugs, known as anti-TNFs, which were launched in Europe a couple of years back. While it took a few months for physicians to get comfortable with those first antibody copycats, demand has since taken off and competition has driven down anti-TNF prices substantially.

50 percent discount

Because biotech drugs are made inside living cells it is impossible to make exact generic copies, as happens with simple pills, so regulators have come up with the notion of approving products that are “similar” enough to do the job. That makes developing them relatively costly, leading to initial expectations of only modest price discounts. Yet biosimilar anti-TNFs now sell at around a 50 percent discount and Novartis, whose Sandoz unit has one of the biggest biosimilars portfolios, reckons discounts could widen to as high as 75 percent in some instances.

Tabernero, who is president-elect of the European Society of Medical Oncology and cowrote a technical paper last month putting the case for biosimilars, told Reuters he would “love to see discounts of 40 to 60 percent”. Based on the rheumatology experience, discounts are likely to start out at around 30 percent.

“If European oncologists are offered highly effective biosimilar agents at a better price, I’m sure they will receive them extremely positively,” said Paul Workman, chief executive of Britain’s Institute of Cancer Research.

Officials running Europe’s national healthcare systems are also paying close attention. Nordic countries and Germany have led the way in using biosimilars but others are now taking action to drive up biosimilar use. Britain, for example, which spends more than 300 million pounds ($375 million) on Rituxan and Herceptin, has set a target for 90 percent of new patients treated in National Health Service hospitals to get biosimilars in future. And the British Oncology Pharmacy Association declared last week it was committed to optimizing the use of biosimilar antibodies in cancer treatment.

New cancer patients, rather than those already started on an existing medicine, are the group most likely to receive biosimilars, at least initially. Still, the nature of treatment, often involving multiple therapy regimens, means this may not hinder biosimilar uptake in the medium-term. “We won’t see instant uptake in every area but we would still expect much faster uptake than has been seen in the past with biosimilars,” said Napp’s Roberts. The EMA has to date approved 23 biosimilars against just four in the United States.

“The EMA has done a good job. It realized many years ago that this is very strategic for managing drug costs in Europe and they set clear, understandable guidelines very early on,” said Oliver Kubli of Bellevue Asset Management in Zurich. With a run of patent expires on blockbuster biotech drugs lasting until around 2022, he is betting on a surge in sales for biosimilar manufacturers in the coming years, even with price discounts of 50 to 70 percent. Roche acknowledged this month it would see some erosion from biosimilars this year, although it is hoping to offset this with better or more convenient follow-on products.—Reuters