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Biosimilars and beyond: innovating for improved patient outcomes

How Europe’s biosimilar landscape has rapidly evolved over the last two decades, bringing biological medicines to more patients than ever before

Celltrion HQ

Today, the healthcare industry continues to be met with extreme pressure – many countries worldwide are facing a potential ‘twindemic’ of seasonal flu and COVID-19, along with workforce shortages, and an unprecedented backlog and patient waiting lists to tackle.

As 2023 begins, companies must forge a path in a market characterised by unprecedented challenges and increasing healthcare needs. Delivering improved patient care has never been more important.

Because of its pivotal role within the healthcare ecosystem, the pharmaceutical industry and its leaders must constantly challenge themselves to deliver new, innovative ways to enable healthcare professionals (HCPs) and healthcare systems to support patients.

The good news is that ongoing challenges typically help to spark innovation and, over recent years, the industry has made significant strides in shaping a healthier and happier future for patients. One of the ways Celltrion Healthcare has done this is by increasing patient access to innovative biologics, and the company remains focused on this in 2023.

Reflecting on the biosimilar landscape
Biosimilar medicines are central to our purpose at Celltrion Healthcare. Put simply, a biosimilar is a biological medicine that is highly similar to another biological medicine, known as a reference product, in terms of structure, biological activity, efficacy, safety and immunogenicity profile. Biosimilars are used to treat a vast range of conditions, including chronic diseases such as rheumatoid arthritis, as well as certain types of cancers.

Over the last two decades, the biosimilar landscape in Europe has rapidly evolved, bringing biological medicines to more patients than ever before. Since the introduction of the world’s first monoclonal antibody biosimilar to Europe in 2013, biosimilars and the resulting competition have produced dramatic savings over ten years in Europe, enabling healthcare systems to make better use of their budgets during these most challenging times. The European market has also pioneered the establishment of a robust system for biosimilar approval, guidelines and regulation, thanks to considerable experience with biosimilar evaluation over the past decade or so. A noticeable benefit of this is that patients have experienced increased access to biological treatment options.

The impact of biosimilar interchangeability
In 2022, an important milestone for our industry was the publication of the joint European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) statement on interchangeability, which supports biosimilar interchangeability – often referred to as switching – for biosimilars approved in Europe. The issue of biosimilar interchangeability is now formally clarified, backed by a wealth of European regulatory and clinical experience with biosimilar medicines for more than a decade.

While it is evident that biosimilar acceptance is endorsed by regulators – due to the proven safety and efficacy of biosimilars, as well as their financial benefit – more awareness and education is still needed about how biosimilars can improve patient care. To help deliver this, at Celltrion Healthcare, we are proud to continue working closely with healthcare professionals (HCPs) and patient organisations across Europe to gain a deep understanding of their educational needs and how we can collaborate to meet their goals.

Innovation in the biosimilar space
Education and the provision of guidance around treatment with biosimilars are key elements of Celltrion’s work. Another hugely important strategic focus for our company is innovation in the biosimilar space.

Celltrion Healthcare delivered the world’s first monoclonal antibody biosimilar, which was a pivotal moment for the health ecosystem. As a company, we believe that biosimilars not only increase access to treatment for more patients through a reduction in healthcare costs resulting from the use of biosimilars but also enable better patient care from HCPs and healthcare systems.

To this end, Celltrion Healthcare is harnessing its heritage in biosimilar development to research new ways to provide value-added medicines and to push the boundaries of biosimilar innovation. Instead of focusing only on the development of biosimilars, we are also exploring ways to expand our pipeline and looking into novel approaches to medicine development, with the end goal always being to address patients’ unmet needs and offer alternatives to existing treatments.

Patients with immune-mediated diseases have to commit to a treatment for years, and often decades, and because of this, patient adherence is a key issue. Especially under pandemic conditions, doctors need to be able to adopt a more tailored approach when it comes to deciding whether patients should receive intravenous (IV) or subcutaneous (SC) treatment according to each individual patient’s condition or disease state.

While the primary objective remains the benefit to patients, innovating beyond the traditional biosimilar space is a critical business decision. As the biosimilar market has gained momentum, competition in the space has also intensified. To remain at the forefront of scientific discovery, biosimilar developers must always consider how they can innovate to preserve the sustainability of products and, ultimately, their future successes.

Challenges and opportunities in 2023
In 2023 and beyond, Celltrion Healthcare will continue to advance in the field of biosimilars, delivering new products and researching ways to improve existing medicines, such as new formulations, administration methods or improved efficacy and safety profiles.

Furthermore, and aside from drug development, market pressure on the need for more regulation in the biosimilar market, as well as patient demand for more education and shared decision-making, is likely to increase.

Improving patient access to value-added drugs
Advancement in biotechnology has led to the development of improved versions of approved biological treatments in the last decade, inevitably igniting discussions among experts about the concept of such innovative biosimilars. According to a recent international consensus reached by expert physicians, improvements in clinical outcomes and drug pharmacology are crucial elements for the definition of biobetters.

However, as there is no standardised guidance available from major regulatory agencies for the approval pathways of biobetters, standardisation in these areas would, for example, avoid duplication of clinical trials and also deliver drug treatments to market in a more efficient and timely fashion for those patients who need them the most. A lack of alignment on issues such as this can undermine patients’ confidence in their treatments and may stifle innovation by also discouraging companies from developing biosimilars with innovative characteristics.

In addition, while efforts are being made by HCPs, patients may have a limited understanding of the benefits and safety profiles of these value-added medicines.  Consequently, patients may find it helpful to understand that, while biosimilars are biologics that have no clinically meaningful differences from their reference product, biobetters or value-added medicines offer improvements for patients versus the reference product – such as the efficacy or safety profile, administration method or ease of use that could result from new indications or patient populations being targeted.

Shared decision-making and improved HCP awareness
The increasing availability of new treatments, including biosimilars and innovative biosimilars, will usher in a new era of education along with shared decision-making – a joint process where HCPs work together with patients to reach decisions about their care.

Shared decision-making is crucial in empowering patients to make informed decisions about their care, and typically improves treatment adherence and outcomes.

As biosimilars become increasingly common, HCPs should be equipped to have important conversations with their patients about the medicines they are being offered and provide them with the information they need to come to a decision together. Involving patients in this process has the potential to improve patients’ quality-of-life and satisfaction with their healthcare.

In the instance of biosimilars, for example, patients may wish to opt for innovative treatment options, such as those offering subcutaneous methods of administration that can be self-administered at home to reduce the burden of their disease on their day-to-day lives.

In conclusion, as we embark on a new year, we are creating a new horizon on the biosimilar landscape. The past decade – and 2022 in particular – has laid great foundations for progress in the acceleration of the biosimilar and innovative biologic market. We look forward to seeing how we capitalise on them in 2023 and beyond.

References are available on request, email

Hyoung Ki Kim is Vice Chairman and CEO of Celltrion Healthcare

7th February 2023

Hyoung Ki Kim is Vice Chairman and CEO of Celltrion Healthcare

7th February 2023

From: Healthcare


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