In the European Union (EU), biosimilars have been available since 2006, and the European Medicines Agency (EMA) has established a robust regulatory framework to ensure their safety and efficacy. The EMA in the EU has been more welcoming to the adoption of biosimilars from the beginning. Since 2006, they have authorised 88 biosimilars. To promote the use of these products, various nations have put in place incentive schemes for payers and providers. This has resulted in widespread acceptance, especially in nations like Norway and Denmark where cancer and anti-TNF (tumour necrosis factor) groups have attained over 80% of the market share thanks to financial incentives and a national tendering procedure.
Biosimilars have become an important tool for increasing access to biologic therapies in the EU, where biologics represent a significant portion of healthcare spending. Biosimilars have been approved for a range of indications, including cancer, autoimmune diseases, and diabetes. The EU market for biosimilars is highly competitive, with multiple manufacturers vying for market share. This competition has resulted in significant price reductions for biologics, which has helped to reduce healthcare costs and increase patient access to these life-saving therapies. The success of biosimilars in the EU has led to increased interest in these products in other regions, including the United States and Asia. As more biosimilars are developed and approved, it is expected that they will continue to play an important role in increasing access to biologic therapies worldwide.
Read more: Sandoz efforts gear up in 2023 to support increasing global demand for biosimilar medicines
Current state of biosimilars in Europe
The current state of biosimilars in Europe is very positive. Biosimilars have become an important tool for increasing access to biologic therapies in Europe, where biologics represent a significant portion of healthcare spending. The availability of biosimilars has led to increased competition and price reductions, which has helped to reduce healthcare costs and increase patient access to these life-saving therapies.
In recent years, the use of biosimilars in Europe has continued to grow, and biosimilars have become an established part of the healthcare landscape. Many countries in Europe have developed policies to encourage the use of biosimilars, including the use of biosimilars as first-line treatments, the substitution of biosimilars for reference products, and the use of biosimilars in tendering processes.
The first biosimilar was approved in Europe in 2006. In 2020 alone, the EMA approved 21 biosimilar products. The most commonly approved biosimilar targets are monoclonal antibodies, followed by granulocyte-colony stimulating factors. As of September 2021, the biosimilar with the most approved indications in Europe is adalimumab biosimilars, with a total of 25 approved indications. Since 2015, the US Food and Drug Administration (FDA) has given the go-ahead to 40 biosimilars.
It's worth noting that these statistics are constantly evolving, as 88 new biosimilar products are developed and approved by the EMA. However, they do give an indication of the significant impact that biosimilars are having on the European healthcare market.
Comparison of biosimilar uptake in Europe vs. other regions
If the proper manufacturers can successfully create and promote these medications, there are many chances for them. Understanding the biosimilar adoption trends in the EU and the US, as well as the factors influencing (and impeding) these trends, is essential to identifying these prospects. Comparatively to other regions, like the US and Asia, Europe has seen a larger uptake of biosimilars. There are a number of causes for this variation.
· Regulatory environment: Europe has a well-established regulatory framework for biosimilars, with the European Medicines Agency (EMA) having approved over 85 biosimilar products. In contrast, the U.S. Food and Drug Administration (FDA) has approved fewer than 33 biosimilar products, and the regulatory framework for biosimilars in Asia is still developing.
· Pricing and reimbursement policies: European countries have implemented policies that encourage the use of biosimilars, such as tendering processes and price controls. This has helped to increase the uptake of biosimilars and reduce healthcare costs. In contrast, pricing and reimbursement policies in the United States and Asia have been less favorable to biosimilars.
· Physician and patient education: There is generally more education and awareness about biosimilars among physicians and patients in Europe, which has helped to increase confidence in these products. In contrast, there is often less education and awareness about biosimilars in other regions, which has led to greater skepticism and reluctance to use these products.
There is a growing demand for cost-effective biologics due to the increasing burden of healthcare costs and the need to ensure access to life-saving treatments for patients. Biologics are complex and expensive drugs, and they are becoming an increasingly important part of healthcare due to their ability to treat serious and chronic conditions such as cancer, autoimmune diseases, and diabetes. However, the high cost of biologics can pose significant challenges for healthcare systems, particularly in low- and middle-income countries.
Biosimilars offer a solution to this problem by providing a more affordable alternative to reference biologic drugs. By reducing the cost of biologics, biosimilars can help to increase patient access to these life-saving therapies, while also reducing the burden of healthcare costs on patients, providers, and payers. This has led to increased investment in the development and production of biosimilars worldwide. This investment is expected to continue to grow in the coming years, as more biosimilars are approved and as healthcare systems around the world continue to prioritize cost-effective treatments. Overall, the demand for cost-effective biologics is an important trend in healthcare, and it is likely to continue to shape the development and approval of biosimilars in the years to come.
There are many successful biosimilar launches in Europe, and here are a few examples:
· Remsima/Inflectra (infliximab biosimilar): Remsima/Inflectra was the first biosimilar to be approved by the European Medicines Agency (EMA) in 2013. Since its launch, it has been used to treat a range of inflammatory conditions, including rheumatoid arthritis, Crohn's disease, and ulcerative colitis. The availability of Remsima/Inflectra has led to significant cost savings for healthcare systems, and it has been widely adopted by healthcare providers in Europe.
· Benepali (etanercept biosimilar): Benepali was approved by the EMA in 2016 for the treatment of rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis. Since its launch, it has been successful in increasing patient access to biologic therapies in Europe. In the United Kingdom, for example, Benepali was included in the National Health Service's "biologics switching" program, which aimed to encourage the use of cost-effective biologic therapies.
· Truxima (rituximab biosimilar): Truxima was approved by the EMA in 2017 for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis. Since its launch, it has been used extensively in Europe, and it has helped to increase patient access to rituximab-based therapies. Truxima has also been successful in reducing healthcare costs, and it has been included in several national tendering processes.
· Rixathon (rituximab biosimilar): Rixathon was approved by the EMA in 2017 for the same indications as Truxima. Since its launch, it has been successfully launched in Europe and has been included in several national formularies.
· The European Medicines Agency approved 6 biosimilars in 2022, (teriparatide, human insulin, ranibizumab, insulin aspart, bevacizumab, and pegfilgrastim).
Biosimilars have been shown to be effective in increasing patient access to biologic therapies while also reducing healthcare costs, and they have been widely adopted by healthcare providers and payers in Europe.
The biosimilar market in Europe is expected to continue to grow in the coming years. Here are some predictions for the growth of the biosimilar market in Europe:
· Increased market penetration: Biosimilars have already gained significant market share in Europe, and this trend is expected to continue. As more biosimilars are developed and approved, healthcare providers and payers are likely to increasingly adopt these cost-effective alternatives to biologics. The availability of more biosimilars will also increase competition, which will further drive down prices and increase patient access.
Read more: Sneak peek into the rapidly growing world of biosimilar start-ups
· Expansion into new therapeutic areas: Biosimilars have been primarily developed for the treatment of oncology and autoimmune diseases, but there is potential for biosimilars to expand into new therapeutic areas, such as ophthalmology and neurology. As more biosimilars are developed and approved for these indications, the biosimilar market in Europe is expected to grow.
· Emerging markets: Europe is not the only market for biosimilars, and there is significant potential for biosimilars in emerging markets, such as Asia and Latin America. As these regions continue to develop their regulatory frameworks and healthcare systems, biosimilars are likely to become an increasingly important part of their healthcare landscape.
· Innovation: Biosimilars are not just copies of biologics, and there is potential for biosimilars to become more innovative and to offer additional benefits beyond cost savings. For example, there is potential for biosimilars to be developed with improved delivery systems, longer half-lives, and enhanced efficacy.
Overall, BioIntel360 suggests that the biosimilar market in Europe is expected to grow, driven by increasing market penetration, expansion into new therapeutic areas, emerging markets, and innovation.
