There are a lot of major advancements linked to biological medicines, including many pathological conditions such as autoimmune diseases and cancer. Biosimilars, a lower cost alternative to many biological medicines, have boosted patient access to a lot of these modern therapies. This is something that’s likely to boost even further, especially as therapies requiring biosimilars are slowly being used by more and more medical professionals. Until now, a lot of this has been held back by patents and market exclusivity, but these will soon expire. It’s thought that by 2029, 34 products will have lost their Orphan Drug Designation (ODD) exclusivity, making room for new formulations and developing biosimilars.
There is no denying the cost of developing biological medicines, which is why biosimilars are growing in popularity and use. Once the patent and market exclusivity of a patent expires, manufacturers can compete by creating biosimilars that are considerably cheaper. They take less time to develop, and they cost less to create. The time and money saving can be passed on, thus providing governments and patients with wider access to affordable treatment. However, despite being expected to have the same medical effect, it’s important to note that biosimilars are only similar to the original product and not identical.
Expediting the Development of Biosimilars
As a lot of the hard work has been done when creating the reference product - such as undergoing regulatory assessments - companies creating biosimilars can reuse a lot of information. This can speed up the development of the biosimilar, as a comparative quality study will be needed. When the original product was being developed, an extensive clinical and non clinical study would have been required before the product was deemed okay for use. This speed, plus the speed gained from the competitive market, means that patients have access to the medicine they need, when they need it. With more competitors, biosimilar manufacturers are having to compete by lowering their costs and making treatment more affordable.
Building Trust and Interest in Biosimilars
As the understanding of biosimilars grows, so does the interest and trust in the products. Though there was doubt and hesitation about using biosimilars interchangeably with the original products, this is slowly dwindling as the similarities between the two becomes more apparent. The fact that biosimilars were only similar, and not an exact match to the original, did make some people apprehensive about their use. However, as more studies are done and the low risk linked to interchangeability, trust and interest continues to build.
The Growing Use of Biosimilars Abroad
In Europe, biosimilars are already being introduced and used rapidly. This has led to a widespread acceptance of biosimilars by providers and patients. However, it’s important that all parties are aware of the benefits, as this will lead to a fair price comparison and greater patient access to medicine. Some governments have already introduced initiatives to boost biosimilars in the market, such as in France where patient associations have had a say in policies. It’s a similar story in Belgium, France and Sweden, where the governments have created incentives for manufacturers, hospitals and patients. These steps are giving biosimilars a boost, which in turn creates a variety of benefits for patients such as lower cost medicine and better access to treatment. In Sweden, the focus is on encouraging various manufacturers to operate within the biosimilars market, as a way to drive competition and lower treatment cost for patients.
The Complexities Surrounding Biosimilars
Though beneficial, there are certainly a number of complexities surrounding biosimilars. This is something that many companies might need help navigating, as it’s a new venture. When policies are in place, there is also a risk of them being destabilised by different measures. For example, exclusive tenders could lead to supply shortage and fixed reimbursements pricing could discourage manufacturers from being involved.
There are also some countries that do not yet have policies and incentives in place, and some have only implemented policies very recently. For some countries, the focus is on ensuring a specific volume of biosimilars is guaranteed. For others, there is no guarantee, and volumes are lost once prices are readjusted. These are complexities that governments around the world will need to overcome.
Education is also a complexity, as there is a lack of education around biosimilars. This is not only the case for healthcare professionals, but also patients and the media. There needs to be more education about the differences and similarities of biosimilars and biological medicines, but also education about how to use them and what they are. Without education, trust in biosimilars is difficult to gain. A lack of education could also hinder the interchangeability of treatments. The hope is, with education, that medical professionals will begin to recommend biosimilars and not just the original product.
Competition in Biosimilar Manufacturing
There is a lot of excitement surrounding biosimilars, especially for life science companies. It’s a great opportunity for treatments to become more affordable, more readily available, and to put the needs of patients first. As more biological products begin to lose their exclusivity, there is even more space for biosimilars to make a mark in the industry. This will lead to a lot of competition, even more so if companies begin building dynamic partnerships.
For biosimilar manufacturers, it’s important to develop the right products at the right price. This will help them to keep up with market demands, whilst also fulfilling the needs of patients. As the EU has a good understanding of emerging policies, Europe is a good place to start when looking at biosimilars. The US Food and Drug Administration (FDA) is only slightly behind, which is likely to lead to competition further down the line. Japan is also being proactive in the industry. It’s hoped that, rather than having to go through the regulations for each individual market, national and regional regulators will share best practices amongst one another.
