Biosimilars – Ten years of increasing access to state-of-the-art therapies (9 min read)

A tenth anniversary could be a fairly unremarkable date in healthcare, but 2016 marked the coming of age of biosimilars – and the next decade is full of promise for patients.

Nov 16, 2017

The initial trickle of new biosimilars – versions of powerful biologic therapies – is fast turning into a torrent as their potential gets recognition, and hard-pressed healthcare systems reap the benefits of potentially huge savings. The impact of biosimilars is profound and dynamic, opening up fresh treatment options for patients, widening access to new and existing drugs and liberating resources to explore future medical innovations.

The first biosimilar came to life in 2006 with little fanfare, but progress has accelerated year after year, principally in Europe but more recently in the US with the landmark approval of Sandoz’s Zarxio in March 2015. Experts estimate that almost 50 biosimilars are now in development and their presence could save the EU and the US a total of EUR 100 billion over the next five years.¹ But this is much more than a business and scientific triumph; it is a pivotal moment for patients.

The need for affordable and new therapies

Biosimilars’ maturity comes as the world’s population is growing and aging at a challenging pace. The World Health Organization has forecast the number of people over age 65 – many with chronic conditions – will leap from 524 million in 2010 to nearly 1.5 billion in 2050. This will be 10 % of the world's population, according to analysts at the international business consultancy Deloitte.²

The jeopardy is highlighted by figures from the International Diabetes Federation, which predicts that the number of people with diabetes globally will rise from its current level of 387 million to 592 million by 2035.³ The financial burden of keeping people healthy, and with a quality of life so they can enjoy those extra years, is immense, and most healthcare systems are already cracking under the weight. For example, the National Health Service (NHS) in England and Wales is struggling to squeeze the GBP 22 billion efficiency savings it targeted for 2020, and Germany is wrestling with rising healthcare costs that now consume 10.4 per cent of the country’s GDP.⁴

Biosimilars – more affordable versions of existing biologics

Biosimilars offer nations and patients a brighter future across a range of conditions including cancer, diabetes, arthritis, multiple sclerosis and anemia, while also opening the door to treatments for rarer diseases.

A biosimilar is designed to match its biologic reference medicine, which is constructed using living cells whose genes have been modified to help them fight a disease. More specifically, a biologic medicine is a complex structure with acute sensitivity and great therapeutic power. The difference in complexity between a biologic and a chemical medicine, such as an aspirin, has been characterized as the range between a pedal bike and a jumbo jet.

Reference medicines are hugely effective and hugely expensive. But availability across Europe is varied. A study found that patient access fluctuated with economics, current prescribing protocols and disease and demographic factors influencing uptake, with Portugal lagging behind most EU countries.⁵ Even in countries with advanced take-up, such as the UK 10 – 14 % of rheumatoid arthritis sufferers are eligible for a biologic that brings effective relief.⁶ Cost is a barrier, but when a reference medicine loses its patent, normally after a decade of full sales, other companies are able to create biosimilars. These are more affordable, and they give patients and health care professionals more choices.

Producing Biosimilars - a high-tech process

Improving access to treatment

Sandoz pioneered research in this sector, launching the first biosimilar in Europe in 2006, and maintains its commitment to create more affordable treatments and improving access. More than 700 biosimilars are now being developed around the world, and Sandoz is leading the way with medicines treating autoimmune conditions, having launched the first biosimilar in the United States in March 2015.

The International Alliance of Patients’ Organizations, which has 276 member groups from 71 countries, works to place patients at the center of care and lobbies for better access to treatments. It stated: “At a time when the burden of chronic diseases is increasing across the world, ensuring that patients can access safe, quality, affordable and modern medicines such as biological medicines is vital to improving health.”

Research has recorded that most biosimilars enter the market priced 30 % lower than their reference biologics, and the savings are greater in many cases. Contract research organization QuintilesIMS comments in its 2016 “Delivering the Potential of Biosimilar Medicine” report: “The prospect of more affordable options that are safe and effective opens up opportunities for health systems to expand access to biologics for more patients, free up resources for investment in new areas and bring relief to pressured healthcare budgets.”

Biosimilars have contributed significantly to increasing patient access across Europe and beyond.

Carol Lynch, Global Head Biopharmaceuticals at Sandoz

Millions of patients and healthcare systems worldwide have already benefited from biosimilars. Medicines for Europe, which represents pharmaceutical companies supplying generic medicines and biosimilars, underscores the promise, with powerful statistics that show biosimilars saved eight EU countries up to EUR 33.4 billion from 2007 to 2020.⁷

The advent of biosimilars for filgrastim, which supports cancer patients undergoing chemotherapy, triggered a 44% increase in patient access in the EU between 2006 and 2013. Patient access has been increased in 60 countries thanks to the presence of biosimilars, according to Medicine for Europe’s figures.⁸ The QuintilesIMS report mentioned above stated that biosimilars could save health systems in the five major EU markets and the US up to EUR 100 billion over the next five years, noting: “As biologic medicines play a more significant role in patient care across a growing number of disease areas, the emergence of biosimilar medicines across Europe and in the United States brings the promise of new sources of value. The prospect of more affordable options that are safe and effective opens up opportunities for health systems to expand access to biologics for more patients, free up resources for investment in new areas and bring relief to pressured healthcare budgets.”

Biosimilars provide additional treatment options across many therapy areas and have increased the numbers being treated as well as reduced costs.

Realizing the potential of biosimilars

But despite that ‘Triple Win’ profile, take-up has been varied. Healthcare systems can have rigid structures that take time to recalibrate with biosimilars. Meanwhile, prospective patients need assurance about their therapeutic efficiency and clinical safety. However, biosimilars are subject to very stringent regulatory guidelines, and they are approved by the same regulatory authorities as reference biologics. Patient safety is paramount in the production of any biologic medicine.

Carol Lynch, Global Head Biopharmaceuticals at Sandoz, acknowledges that there is a job to be done in spreading the message. She adds: “Biosimilars have contributed significantly to increasing patient access across Europe and beyond, both by freeing up funds for healthcare systems through much-needed competition and by driving increases in overall biologic usage.” Medicines for Europe maintains that biosimilars can create a virtuous circle with reduced costs leading to more patients treated, increased therapy options, funds released for hospital build programs and improving capacity to treat. This potential is only made possible by high-level research and development, a mission to educate patients and help healthcare systems adapt to reap the full rewards of biosimilars.

Sandoz has a deep biopharmaceutical heritage, starting with the development of penicillin in the 1940s through early research, to a point where its biosimilars have been used in clinical practice for more than ten years and have more than 340 million patient days of experience across 86 countries. Access to affordable and high-quality medicines is a cornerstone of global biosimilar development, which are a potent force in providing health to the world.

Biosimilars – Increasing patient access

Biologics

Biologics are produced by a complex process involving living organisms. These medicines have revolutionized the treatment and prevention of many disabling and life-threatening diseases: diabetes, psoriasis, arthritis, growth disorders, inflammatory digestive disorders and certain types of cancer.

Biosimilars

A biosimilar is a follow-on medicine of existing biologic (also known as a ‘reference biologic’) when the patent has expired. To be approved for use, a biosimilar has to match the reference medicine in terms of safety and efficacy in patients, demonstrating no clinically meaningful differences. Depending on policies and systems implemented by countries’ healthcare authorities, biosimilar medicines have the potential to improve access challenges faced by patients. Sandoz, a Novartis division, is the pioneer and market leader in biosimilars. It has a leading biosimilar pipeline and plans to launch five biosimilars of major oncology and immunology biologics by 2020.

Benefit to patients

The introduction of affordable, high-quality biosimilars improves access to lifechanging medicines for patients worldwide. The EU saw a 100 % increase in use of biologic treatments after the introduction of biosimilars in the EU.