LONDON: The United Kingdom will miss out on savings worth hundreds of millions of pounds on off-patent medicines, an industry group warned, with drugmakers put off by concerns around pricing and lack of usage in the National Health Service (NHS).
As many as 50 complex biosimilar medicines – imitations of drugs for diseases including cancer – are unlikely to be launched, according to a report from Medicines UK, the body that represents generics and biosimilar companies in the country.
Some of the drugs will likely be available in other European nations and the United States, leaving the United Kingdom paying higher prices for branded medicines, it said.
Dozens of biological medicines are losing patent protection in the coming years, opening the door for biosimilars.
Unlike generics, which are exact copies of the drug they are based on, biosimilars can’t claim to be identical to the original medicine.
Many are highly complex and expensive to produce, yet can still represent substantial savings if rolled out in public health care systems.
Some are biosimilars that Sandoz, one of the largest manufacturers, said it is unlikely to launch in the United Kingdom.
It blamed the government for trying to keep the companies that develop original branded drugs onside, as well as a tax and payment system that doesn’t distinguish between the two types of drugmakers.
“We struggle with government,” said Sandoz chief executive officer Richard Saynor.
“It’s confused and it’s trying to clearly keep the originator business happy, yet recognising we’re the very thing that can drive down savings.”
While Saynor said both the NHS and the drug cost regulator understand the value that the off-patent drug industry brings, he said this argument is harder to make to the Department of Health.
Manufacturers like Sandoz complain the UK’s tax clawback programme works as a barrier to entry because it applies to biosimilars in the same way as branded medicines.
The programme is aimed at putting a limit on NHS spending on medicines. If an agreed level is exceeded, companies pay money back to the government via a rebate on sales of their drugs.
While the clawback rate is typically lower for older medicines, that also depends on the price. “We get taxed as though we’re an originator,” Saynor said.
Discussions are underway with the pharmaceutical industry about changes to the system, though off-patent companies are not party to the talks.
The Medicines UK research showed 74 drugs will lose patent protection between 2026 and 2032 that could be replaced by biosimilars.
But about 50 are unlikely to be launched, including the cancer medicine blinatumomab and cholesterol drug alirocumab, because the branded versions are not widely used on the NHS.
The 50 medicines currently cost the health service about £608mil (US$806mil) a year, according to the research, excluding any confidential discounts.
Sandoz and others argue it’s effectively a Catch-22, if a cheaper biosimilar was introduced on the NHS, it would change cost-effectiveness calculations and a much larger group of patients could be eligible for a drug.
That, in turn, would make it more economically viable for a company to launch in the United Kingdom.
There are examples of that happening. Use of the cancer drug bevacizumab was expanded to colorectal cancer after biosimilar pricing made it value for money. When a biosimilar adalimumab was introduced to the NHS, more patients with rheumatoid arthritis were able to benefit from it.
The NHS has talked up the potential for biosimilars to lead to massive savings and has set up a framework to ensure they are used. The issue is becoming more relevant to the health service, with many more biosimilars set to come to market in the coming years as a wave of drugs lose patent protection. — Bloomberg
