The jostling for position in the crowded insulin market is intensifying as a surge of biosimilars enters a dynamic arena with an ever-growing patient population.
Mylan, the global healthcare company, has chosen the UK for the launch pad of its much-anticipated biosimilar version of the Sanofi blockbuster Lantus (insulin glargine), which it hopes will become a significant player.
The company also wants the British profile – with its track record of a swift adoption of new drugs – to model the benefits for other European countries that are traditionally more resistant to the charms of biosimilars.
The fertile UK landscape is an alluring springboard for biosimilars, with Mylan recording strong uptakes in previous launches. Jacek Glinka, the company’s European president, was quick to point out the positive climate.
“British people have a practical approach and can differentiate between the true science and the fake science, and arguments about whether efficacy and safety is the same for biosimilars and original products,” he said.
“There is a more positive environment for the uptake in the UK compared to other European countries as there is good support from the government and the national competent authorities because they can see both the saving and the increase in patient access.”
Mylan believes that early proof of high savings for the NHS drugs bill will send motivating tremors through other countries where it has struggled to convince governments to adopt generics and biosimilars.
“The UK can take the lead on showing other countries how to properly manage the opportunity of biosimilars,” he added. “The dream is that, on Day One when the product loses its patent, 100% of the patients use the biosimilar and the opportunity has been optimised.
New drugs
“In the EU5, between 2006-2014, there has been a 44% increase in access to therapies because of biosimilars, yet some countries remain slow despite proof of savings and increased
patient access.
“They need to recognise that this is the opportunity of the century and they should seize it.”
The diabetic population shows no sign of reducing any time soon, with research suggesting that the number of diabetics in Europe is expected to grow from 58 million today to 67 million by 2045, according to the International Diabetes Federation. Worldwide, there are 352 million at risk of developing type 2 diabetes.
The need for new drugs follows that trajectory with a report from analysts Research and Markets predicting the insulin market will continue to grow at an annual rate of just above 6%.
Glinka and UK country manager Jean-Yves Brault took time out from putting the finishing touches to their launch campaign to talk to PME about the potential from an insulin biosimilar and the promise of Mylan’s pipeline, which is fuelled by an annual Research & Development spend of around $650m.“Drugs worth €47bn are approaching the patent cliff so, assuming that biosimilars could take up a portion of that, then it could create €15bn savings in Europe, if not more,”
said Brault.
“It is about increasing access. Bringing a biosimilar insulin to the market will create extra options for healthcare professionals and, in turn, lead to more people being treated, and treated better, for their diabetes. We have a huge range of products and complementary skills which allows us to interact with the hospital pharmacist, the Clinical Commissioning Groups (CCGs) retail pharmacists, the General Practitioners and secondary care doctors, and we also have good partnerships with patient associations, which puts us in a good place to understand the needs of patients
and payers.
Fewer resources
“We don’t only supply a medicine,
we try to position it as a value package built around product values and connected service. With insulin, we are creating new educational and awareness programmes based on the fact that biosimilars come at a better value proposition than the originators. The money saved can be reinvested for better early patient diagnostics or education, and more nurses to help patients to better control their diabetes and decrease their risk of developing more chronic conditions.”
Brault added that the biosimilar launch would represent an embodiment of Mylan’s approach to using biosimilars to drive better health outcomes.
“We have a strong portfolio and regard ourselves as being part of the solution,” he said. “We want to treat more people. Our ageing populations mean that more people need support while less and less people are paying tax. There are fewer resources so we have to offer innovative products at a right value proposition with complementary tools, education and a real wish to partner. We want healthcare systems to have enough resources to treat people and still have the resources to treat future generations.
“We try to stay connected with our patients because, if we pay attention to their needs, and unmet needs, we can create the value proposition in partnership with all the stakeholders. It’s pretty much our DNA.”
Mylan, which has three other drugs working their way through the market authorisation process, believes biosimilar penetration will continue to vary across countries and that recognition of the financial risk of developing a biosimilar, along with its ability to save costs, is not universal.
A traditional approach to the costs of production and pricing is also hampering progress, according to Glinka.
Hybrid solutions
“Biosimilars are difficult products to develop and not all products make it.
Failures can be expensive,” he said. “But payers are fixed on models of a new chemical entity, which comes at a high price, or a generic, which can be priced down. There should be recognition of a ‘Third Way’, something that is not a new chemical entity but is also not a small molecule. We cannot expect these products to be commercialised with just a 10% mark-up because the return would be too small and no-one would be tempted
to invest.
“We are discussing with governments how they can give us an opportunity to commercialise products to generate sufficient return to be able to invest in the next, 3rd and 4th generation of biologics. We are looking at a hybrid solution that offers favourable pricing and increased access for the patients. We want constructive dialogue, but it’s different from country to country; in many it is a long and difficult process but, the more the government is conscious about the opportunity, the more proactive they are and the more productive the discussions are compared to those not interested or willing to consider the opportunity.”
Individual case studies may have the most powerful impact, with grass-roots feedback influencing government thinking. In the UK, a gain-sharing scheme in Southampton was developed locally where savings from introducing a biosimilar were shared to improve delivery for both patients and clinical staff.
“It created immediate interest and is a good showcase for other countries to see the difference,” added Glinka.
“Developing biosimilars is very expensive and there is a high risk of failure, but we are not taking a passive approach and saying we will not risk the money. We put the money up front and have one of the most robust pipelines in the world for biosimilar products. We are committed to bringing these vey complex products to the market and offering them to patients in Europe.
“We invest the money for the benefit of the patients and to tackle something very difficult. Biosimilars are the supercars of healthcare and are very difficult to bring together, so we have a huge sense of pride and it’s a huge contribution to be able to offer them to the healthcare systems.
“Mylan is always bold; it’s part of our DNA. We are incredibly committed to this and we are never afraid of being bold and we will continue to make the case for biosimilars across Europe and the world.”