Ask the Experts: what are the challenges surrounding biosimilar medicines? (Part I: current progress and solutions)

Written by Heather Jones, Future Science Group

In our two part ‘Ask the Experts’ series, we discuss the benefits, challenges and implications of biosimilar medicines, providing perspectives from a panel with expertise including research, clinical practice and policy development. What are the biggest challenges surrounding the introduction of biosimilars? In which ways could any economic savings be reinvested? How will the field progress in the next 5 years? With an increasing number of biosimilar medicines being developed, our experts address these questions and more.

Bringing together insights from the hospital clinic to the pharmaceutical industry, our experts are Julie Maréchal-Jamil (Medicines for Europe, Brussels, Belgium), Johan De Munter (University Hospital Ghent Cancer Center, Brussels, Belgium), Zorana Maravic (Digestive Cancers Europe, Brussels, Belgium) and Wojciech Jurczak (National Institute of Oncology, Cracow, Poland).

Take a look at the first instalment of this discussion below that looks at the progress that has already been made in the field, along with the challenges in biosimilar development and introduction.

Keep an eye out for Part II of the discussion, which explores the subsequent potential for reinvestment in health and what the future holds for the field of biosimilars.

What progress has been made in the field of biosimilar medicines in oncology over the past 5 years?

Wojciech Jurczak: Well, in one word we can say an immense progress, both in the number of approved drugs, and the way they are appreciated by both doctors and patients. We were working on biosimilars from the very beginning. One may call biosimilars “the generics for biological drugs”. Our understanding is that introducing biosimilars means in fact “biosimilar for biobetter.” Although they in themselves do not offer any superior therapy, they reduce the cost of health care, largely increasing the access to therapy and substantially facilitating the introduction of novel drugs. The doctors have accepted that biosimilars are equally good and safe, and that the patients will not be treated by any sort of substandard solutions. There has been an immense work, not just in the lab but also in the public arena, press and in the congresses, which gradually led to their general acceptance. The European Medicines Agency (EMA) and US FDA introduced a special legislation pathway to register biosimilar drugs. I think that over the last 5 years we have been persuaded that the drugs are safe and efficient. We have also been persuaded that our European and American approval system is one of the best in the field.

Julie Maréchal-Jamil: Looking back 5 years ago, there were no biosimilar medicines available in first line oncology treatment, only in supportive oncology care (e.g. filgrastim).

Today,  peg-filgrastim, bevacizumab, rituximab, and trastuzumab are all available (authorized for use) for patients in the oncology setting. The range of approved oncology indications now encompasses the treatment of colorectal, brain, lung, renal (bevacizumab), non-Hodgkin lymphoma, leukemia (rituximab), HER2-positive breast cancer, metastatic gastric and gastroesophageal adenocarcinomas and other cancers.

Biosimilar medicines are in the process of significantly re-shaping the access to biologic cancer therapies.

The latest ESMO (European Society of Medical Oncology) global survey on the knowledge and use of biosimilars in oncology confirms this trend and indicates that nearly one in two prescribers use biosimilar medicines in their oncology practice. This is very significant in terms of the evolution of medical practice. Oncologists around Europe are recognizing the benefits biosimilar medicines bring, easing financial constraints and ultimately treating more patients and earlier in the disease progression, where medically sound. This is a game changer in the oncology field where time is of the essence and resources are tight.

Zorana Maravic: Over the past 5 years in the field of oncology, biosimilars of two blockbuster drugs that changed the landscape of lymphoma and breast cancer – rituximab and trastuzumab – came to the market. What was already perceived as a very high uptake of these drugs increased even more once biosimilars became available, giving additional patients improved chances of survival. Unfortunately, the uptake in certain countries is still very poor and we observe huge differences between countries where market penetration of biosimilars is up to 90% (such as in hospitals in Denmark) opposed to some lower-income countries where biosimilars contribute to only 10% of the market, such as in some Eastern European countries where these efficient, cost-saving treatment options could contribute to sustainability of health care systems. What is even more interesting is that in some of these countries, inequalities in access to important biologic treatments for cancer patients have been observed.

Overall, biosimilars led to a decrease in prices, which supported the sustainability of overstretched healthcare systems, and more importantly, looking from patient perspective, allowed cost savings to be re-invested into innovative medicines and patient care. Over the same period of time, a substantial amount of work was done on multi-stakeholder education and in creating various solutions to fully unlock the potential of biosimilar medicines. On the other hand, the market became highly crowded and competitive, causing some companies and products to go off the market.

In 2020, biosimilars for bevacizumab should become available on the European markets, which will hopefully enable more colorectal cancer patients to receive this essential drug.

Johan De Munter: The EMA approved the first biosimilar in 2006. This was a recombinant human growth hormone. Quickly after followed the approval for biosimilars of epoetin alfa in 2007, and in 2009 an approval for the biosimilars of recombinant human granulocyte colony-stimulating factor. These products were all growth factors, a class of medicines used in the supportive care of cancer treatments.

Late 2018 saw the EMA approval of the trastuzumab biosimilar. As a result, monoclonal antibodies where the second class of medicines that became available as biosimilars for active treatment in cancer care.

Over the past few years, the EU has approved a large number of biosimilars as the monitoring system for safety concerns in Europe has not identified any relevant difference between biosimilars and their innovator reference medicines.

A large part of today’s most innovative treatments for cancer are biological products and I’m sure many more are in research and development. But these innovator drugs can be very expensive. The high cost of innovator products for societies, as well as for end users, can stand in the way of equal access to treatment.

In the near future, patents on some widely used biological drugs will expire. This will create new opportunities to develop and approve more biosimilars in cancer care. In this way additional treatment options will be created to tackle the cancer burden.

This new class of medication has brought additional challenges for health care professionals, such as cancer nurses.

Therefore, it will be of utmost importance to provide the necessary recognition, investment, education and training of cancer nursing to the benefit of the optimal and safe use of biosimilars in cancer care across Europe.

What hurdles exist in the field and how could these be overcome?

JMJ: There are several pillars in which we should continue to collectively invest to ensure biosimilar medicines’ benefits deliver on the promise of greater access to treatment.

First is the importance of continued education, of all stakeholders and policy makers, on the basic scientific principles and their confirmation through experience to date. There are a number of existing resources which need to be disseminated further to reach the healthcare community more broadly.

Second, experience and good practice sharing is required. Clinical experience is growing by the day and policy makers have tried a number of policy interventions and combinations thereof. This information should circulate among EU member states but also among specialist physicians across therapy areas so that all can benefit from this collective knowledge. Further competition enablers are necessary in the biologic medicines sector. Creating sustainable competition requires appropriate framework design, and experience has shown that use and prescribing incentives are required to stimulate competition but also that removing barriers (direct and indirect) to competition is often necessary as well.

Regulatory science advances must also be taken into account.  Science and technology are constantly evolving, in turn, the regulatory framework needs to adapt to this evolution to ensure it remains both fit-for-purpose (e.g. removing redundancy) and optimal, to inform the regulatory assessment and decision-making process.

It has become very clear that there is no ‘one size fits all’ solution and that successful policy frameworks lean on multiple policy measures and actively learning from experience, shaping the framework forward.

ZM: In markets with low biosimilars penetration rates, which often have restrictions in patient access to biological treatments, changes in policies are necessary as greater improvements are rapidly required. When it comes to market stability, more manufacturers should be encouraged to invest in this area. In order for this to happen, procurement procedures have to be done differently. Lowest price should not be used as the sole determining factor, but other factors such as quality, delivery, availability and innovation should be taken into consideration. Multi-winner tenders are crucial to avoid shortages and safeguard sustainability.

Looking from our perspective, the most important hurdle is communication. Further education is necessary. Although there is a rigorous scientific evaluation followed by post-marketing safety monitoring and evaluation via pharmacovigilance done by the EMA for all biosimilars, there are still uncertainties among patients and even some clinicians about biosimilars. To date, there are over 55 biosimilar medicines approved in the EU and over 1 billion patients’ days’ experience showing safety, quality and efficacy of biosimilars. But it appears that concerns still exist. It also seems that not all clinicians can explain in simple terms what biosimilars are. We have to make sure that communication about biosimilars is positive, focusing on outcomes and benefit for patients, not solely on cost savings. Therefore, in 2020, Digestive Cancers Europe is starting a patient-led European effort to increase trust in biosimilars through a multi-tiered education campaign that will change the narrative of biosimilars. This project will involve different stakeholders (patients, clinicians, nurses and pharmacists), all of which are equally important in communication around biosimilars as we believe in the one voice principle. Improved communication could help avoid the nocebo effect. Also, greater patient knowledge of biosimilars as one of the treatment options would facilitate the shared decision-making process.

WJ: The first difficulty is getting the patients to understand that they should participate in biosimilar studies. In the other clinical settings, we either offer novel drugs to the patients with no other accessible therapy, or there at least might be a potential benefit for those who participate. In the biosimilar studies, the patients always have an approved alternative, there are no potential clinical benefits for themselves. If the study is successful, the results will be equivalent to the current standard of care. So, in fact, I would say that the heroes of biosimilar development are the patients who are willing to take a risk without any potential benefit for themselves, understanding that this is important for the whole system. If we want to have successful biosimilar studies, we have to give patients everything they need, which means time, experience and willingness to talk through all their doubts.

JDM: Through the efforts made by different stakeholders in healthcare and healthcare industries, there is an encouraging level of prescriber use and general knowledge of biosimilars in oncology. To my knowledge, regarding successfully implementing new cancer treatments, more is needed than the prescribers’ education and perspective.

It will need an interdisciplinary approach that involves team members from different disciplines working collaboratively when implementing the use of biosimilar medicines, to set common goals, make decisions and share resources and responsibilities in the best interest of the patient with cancer.

Cancer nurses are responsible for the care and safety of patients with cancer, and are involved in complex procedures, including cancer treatment administration. In some countries across Europe, cancer nurses are also able to prescribe treatments. As the largest group of professionals working at the forefront of healthcare, the contributions of cancer nurses are still being under-recognized across Europe.

Increased access to biosimilars, together with the rising incidence of cancer, will raise the expectations of patients and their families to receive these treatments in a safe way and with the necessary information and support. This ongoing evolution also raises the expectations placed on cancer nurses in Europe.

Despite what some think, the important aspects of the cancer nursing role in cancer treatment contains more than the five rights of medication administration (right medicine, right dose, right route, right time and the right patient). Cancer nurses play a pivotal role in the multi-professional health care team in the management and safe delivery of biologic and biosimilar medicines.

Cancer nurses provide timely, relevant information to ensure patients can engage in the clinical decision-making process in switching from a reference to its biosimilar medicine or vice versa, and in their care management to understand their treatment and potential side effects in order to appropriate (self) management during the whole cancer burden.

Therefore, cancer nurses, together with the patient and their family, undertake assessment and care interventions, setting goals to create shared decision treatment plans. This involvement of cancer nurses calls for unconditional access to education and training in cancer nursing, to maintain high standards of cancer treatment and care.


Julie Maréchal-Jamil

Director Biosimilars Policy & Science – Medicines for Europe

Since October 2015, Julie has been leading the Biosimilar Medicines Group, a sector group of Medicines for Europe. Her work consists of creating and nurturing partnerships with experts in pharmaceuticals and across healthcare systems, balancing interests for a resilient and sustainable healthcare framework. The main objectives of the biosimilar medicines group are to support and facilitate the design, evolution and implementation of policies aimed at creating efficiency gains thanks to biosimilar medicines use and greater access to health services and products for all patients. From January 2019 onwards, she co-chairs the biosimilars committee of the International Generic and Biosimilar medicines Association (IGBA) focusing on convergence of global policies and standards. Her knowledge and understanding of the scientific, regulatory and health policy environment at EU and international levels, as well as of the functioning of the EU ecosystem, greatly supports her effective engagement with all the players involved. Prior to this, Julie was part of Medicines for Europe’s regulatory and scientific affairs team for 8 years, with responsibilities in the areas of quality, compliance, environment, health & safety as well as bioequivalence. With an MSc in Pharmacology, she previously worked in the pharmaceutical industry.

Johan De Munter

Johan De Munter has been working for almost 20 years as a registered nurse in the oncology and hematology field. After several postgraduate qualifications, he started to work as an oncology/hematology nurse consultant in a general hospital. In 2010, he transferred to University Hospital Ghent Cancer Center to work as a nurse consultant in the hematology/stem cell transplant unit. Professional interests include healthcare providers and patient education, supportive care needs, AYA (adolescents and young adults) cancer and survivorship care with a focus on evidence-based cancer nursing, quality of care, advocacy and communication.

He is currently a board member and past president of the chemotherapy working group in the Belgium Society for radiotherapy and oncology nurses.  He is an active member of the Belgian Hematology Society nurses committee. Since 2018, he has been an elected European Oncology Nursing Society Board member and was voted President Elect in 2019. He is also a voluntary board member of the Majin house, which is a support home for people with cancer in Belgium.

Zorana Maravic

Zorana Maravic is Director of Operations at Digestive Cancers Europe, previously EuropaColon, the first and only European digestive cancers patient umbrella organization. In her position, Zorana is responsible for the co-ordination and support of member groups, as well as establishing relationships with new organizations in order to continue the network growth. As an experienced project manager, Zorana has managed many of the projects undertaken by the organization, such as the survey on the unmet needs of patients living with metastatic colorectal cancer, which recruited more than 800 patients, with the results disclosed in several publications that Zorana authored. She has also organized several masterclass events (educational annual meetings for member groups), developed various awareness campaigns including European Colorectal Cancer Awareness Month Campaigns, participated in various projects organized by the pharmaceutical industry and independent consortia, and worked closely with the Patient Advisory Committee on the production of different educational materials to support patients. In addition, Zorana acts as a public speaker on topics such as patient support, biosimilars and CRC screening.

Wojciech Jurczak

Wojciech Jurczak is a consultant and professor of hematology at the National Institute of Oncology (Cracow, Poland), where he leads the local lymphoma team, serving for the southern eastern part of the country. It is the reference center for about 6 million people. Most of his research activity in the first 15 years of his profession has been related to the development of monoclonal antibodies and other targeted therapies in lymphomas. In the last decade, his lymphoma team has taken part in over 100 clinical trials, including registration studies for Ibrutinib, Acalabrutinib, Zanubrutynib, Idelalisib, Belinostat, Ventoclax, Lenalidomide, Brectuximab vedotin and Rituximab biosimilars.


Interested in finding out more about biosimilars? Visit Medicines for Europe