A decade after the introduction of the first biosimilar into the market and the good experiences of patients and healthcare providers with these medicines, the shadows of doubt over the safety and efficacy of these treatments have mostly blown away. With the world embracing this leap forward in innovative medicine, we have to ask what is needed to ensure that we make the most of it. Can these advances become a mainstay of treatment in healthcare systems around the world?
The introduction of biosimilars does not only offer new solutions, new partnership opportunities and new innovative approaches, it also contributes to a more sustainable healthcare system, delivering value beyond the product itself. We must build on the experience gained over the years of development and identify new opportunities where these medicines can truly add value. However, this cannot be done in silos. The pharmaceutical industry needs to partner and collaborate more closely with healthcare and regulatory authorities to ensure that a successful outcome is achieved from every opportunity. We can continue to push the boundaries of innovation but unless we can put solutions in place that allow the right people to benefit fully, at the right time, we will have ultimately wasted a very unique opportunity.
Looking back on how far we have come, we should celebrate the true breakthroughs that have been made in the innovative options we can offer patients in today’s world. I strongly believe that the introduction of biosimilars is one of the biggest leaps we have made towards a sustainable healthcare system. However, the road was not an easy one. The approval of the first biosimilar in 2006 by the European Medicines Agency (EMA) marked the emergence of this new area in healthcare. This also marked the culmination of many years of commitment and people’s personal journeys to ensure that we can deliver something that truly adds value.
When it comes to the development of biosimilars, the process is intrinsic and individually designed, to guarantee control of variability in the molecular structure (which is observed in the production of all biologics) and ultimately deliver a product that meets all of the targeted specifications. This is a very lengthy and stringent process which can take up to an average of seven to eight years to complete. The strict requirements do not end there – the process is designed to deliver the right product at the right time. Accurate planning is thus crucial to ensure that the product is delivered to the patient within the right timescales. All of these parameters need to be carefully considered while not making any compromises on the quality of the product, hence robust manufacturing and supply capabilities and experience of the pharmaceutical manufacturer play a critical role.
So while I am excited to see the journey we have been on so far with biosimilars and the true breakthrough this has offered, I remain more excited about the future – the changes I am seeing in the healthcare community’s approach and what we can make of this opportunity. But we still have some work to do. By working together to continue to utilise all of the breakthroughs, establish biosimilars as a true mainstay of treatment and deliver the support systems needed to allow patients and healthcare providers to benefit from more choice and more value, we take one further leap towards creating a sustainable healthcare system. At Boehringer Ingelheim we are excited about this opportunity and will continue to expand the boundaries, with a firm belief that biosimilars will contribute significantly to the future of our healthcare systems around the world.