The biosimilars journey seems to have more turning points than a busy railway goods yard while the prospect of healthcare nirvana remains in the tantalising distance.
The promise of multi-billion-dollar savings for hard-pressed health systems and new, effective treatments for patients has struggled to live up to its star billing, according to critics.
The recent celebrations for the 10th anniversary of the first biosimilar launch in Europe were tinged with concern that the eagerly awaited party bags of goodies for physicians and patients have been, so far, underwhelming.
Although success stories have been impressive – healthy patients and genuine savings that are re-invested in local care – there is still a pressing need and desire to translate those to a wider audience.
Carol Lynch, recently elected chair of the European Generic Medicines Association, believes it is time to press the accelerator pedal to drive the dividend from biosimilars across the health spectrum.
She has issued a rallying call to all stakeholders to ‘step in and step up’ efforts to improve access and share effective practices so that new biosimilars therapies, regularly tagged as the answer to fracturing healthcare around the world, become routine rather than rare.
“There are a lot of things to be very proud of in Europe,” says Carol, who is also global head biopharmaceuticals and oncology injectables at Sandoz.
“If you look at the number of product approvals they are now at 20-plus in the EU and there are a number of good news aspects to the savings delivered to healthcare systems. For instance, in Germany, an estimated €0.5bn has been saved with the introduction of Epo biosimilars and there has been a dramatic expansion in the use of the biosimilar filgrastim in the UK. But at the same time we know that patients having access to biologics is still on the low end compared to the number that would benefit from receiving them, so there is still work to be done.”
All stakeholders [need to] improve access and share effective practices
Triumphs are peppered across the European market but joining those points together is proving more troublesome.
“The lessons to be learned are that you cannot necessarily pick up one methodology and plonk it in another place and it will be successful,” she adds. “Each system has to find its own way. You can find the commonalities and apply them but the key is to find champions locally who can see the benefits and drive them through. That is where we all have a role to play so the benefits are there for the whole healthcare system.”
The 2016 Biosimilars Medicine Group Conference, held in London in April, was garlanded in positive statistics: a 44% improvement of patient access with filgrastim, savings in eight European countries rising to €33.4bn by 2020 – placed as high as €98bn by some observers – and the prospect of 12 major biological medicines losing exclusivity by the end of the decade. IMS research underwrites the figures with predictions of competition driving down prices and generating a wider take-up.
“The London conference was generally positive but there was a lot of reflection along the lines of ‘have we done enough and what more can we do?’,” adds Carol. “The key takeaways were stakeholder involvement and having incentives in the right place, and there was also a lot of discussion about patient involvement.
“In Europe, there is a growing hypothesis that we need the right incentives in place for the payers, physicians and the patients. If you look at examples where there has been an adoption of biosimilars, it is generally because you have had a local player – a physician or a payer – who is championing the benefit to the whole system not just their silo, and the incentives are aligned and in the right place.
“The challenges are that not all healthcare systems are the same so the good examples are not directly translatable which means we have to make sure the right people are well enough informed to make good decisions and that there is sufficient data to inform choice.”
A fertile landscape for biosimilars also needs patient and clinical staff advocates to join the spirited industry chorus, she says. In Norway, biosimilars were welcomed by knowledgeable patient groups who were consulted at every stage and invited to help design the research studies. The patient voice has been a significant feature of many schemes where biosimilars have muscled through cost and prescription barriers.
“If you look outside the pharma industry, there are a number of persistent financial pressures in most economies around the world. At the same time, we have an ageing population, with more and more products that help people cope with the diseases of old age, which is putting tremendous pressure on healthcare systems. There needs to be alternative solutions because keeping going the way we are is not sustainable.
“Most healthcare systems budgets are rising because of the cost of biologic products so biosimilars have a role as part of the solution to this increasing problem. Whether they will become a landmark in the history of medicine, I don’t know, but they are extremely important in driving sustainability for healthcare systems.”
Although the savings do not match generics, the use of biosimilars can still be transformative and Dr Virginia Acha, the Association of British Pharmaceutical Industry’s executive director research, medical and innovation, echoes the positive note.
More than 700 biosimilars are being developed around the world
“A lot of people can get caught up in the thinking that biosimilars are not being well used and we have to manage expectations,” she says. “But we have to remember it took a while before people got familiar with generics and how to use them, buy them and how to prescribe them. It is an over-statement to say we haven’t made much use of biosimilars and more accurate to say there are growing pains – we have to do things differently and that takes time. Our healthcare system is far from simple and doing something that has never been dealt with before is going to lead to conversations, deliberations and some arguments.”
Tim de Gavre, chair of the British Biosimilars Association, which was recently formed to improve the understanding and use of biosimilar medicines in the UK, says that many Trusts and Clinical Commissioning Groups (CCGs) have yet to find agreement on how to ‘gain-share’ the benefits from potential cost savings.
The picture is clouded even further with physicians taking opposite views even within therapeutic areas but he believes pressure from the NHS to realise economies will lead to increasing prescription rates.
“We have some big drugs, such as adalimumab [AbbVie’s Humira], going off patent so that pressure will intensify,” he adds. “I think we are making progress and as people get more comfortable and confident prescribing that will accelerate.”
Recalibrating complex health systems can appear frustratingly glacial but establishing smooth delivery will make it easier for the next wave of biosimilars to reach patients quickly and contribute to cost savings.
More than 700 biosimilars are being developed around the world with Sandoz on target for ten new filings by 2017, and big prospects expected in oncology.
“Just having competition lowers cost because we know the innovative companies will need to bring down their costs at the same time,” adds Carol.
“One of the biggest drivers of a shift in market dynamics will be the number of competitors. It is fairly low at the moment but that will change along with new filings and with the number of biologics coming off patent.”
She is convinced that biosimilars are essential in treating patients with chronic conditions such as rheumatoid arthritis, irritable bowel syndrome and psoriasis, because they provide the same uplift in quality of life as the biologics that may be denied on cost grounds.
“My hope for the future is that every patient who could benefit from a biologic, be it innovative or biosimilars, has that chance,” says Carol. “By bringing biosmilars to market we will also carve out more space and funds for innovative medicine in the future.
“The future of biosimilars for every element of healthcare is making sure the stakeholders work together to create new systems of delivery. It is about working together – stepping in and steeping up to make this a reality.”