Out-Law Analysis | 27 May 2021 | 9:35 am | 5 min. read
Manufacturers of biosimilar medicines need to develop a comprehensive plan for promoting their products to healthcare professionals and patients to take advantage of forthcoming opportunities for growth in the UK market.
Patents covering many popular biologics are set to expire in the years ahead, providing scope for biosimilar manufacturers to launch rival products. Regulatory and healthcare bodies are seeking to encourage this development in the UK through new procedures and guidance, since competition in the market will drive down the cost of medicines to the taxpayer and increase patient access to these important medicines.
However, as barriers to the launch of biosimilars fall away, their manufacturers must nonetheless address the risk that a lack of awareness and understanding of their products will impede uptake.
This need for an educational drive was a central topic discussed at a recent Westminster Health Forum event, where I discussed with my fellow panellists the priorities for getting biosimilars licensed for use in the UK and into the NHS. Those from UK parliament, industry bodies, regulators, the NHS and patient groups at the conference all supported collaboration between all participants in the UK healthcare eco-system in order to educate healthcare providers and patients alike to enable shared patient-clinician decision making when switching to biosimilars.
Open discussion to increase understanding of the through testing of biosimilar products to meet regulatory requirements – including the ongoing post-marketing authorisation monitoring that applies – should breed trust and confidence
Biosimilars are medicinal products derived from biological sources. They are large, complex molecules such as antibodies. Biosimilars are named as such because they are highly similar, but not identical, to originator biologic products.
The European biologics market has been steadily growing over the past decade, prompted by impressive innovations from originator companies. According to a report published by health information technology company IQVIA, the European biologics market is now valued at €8.4 billion. The biosimilar share of that market has been increasing too, with a 58% increase in biosimilar sales over the last five years. This is because the product patents for many of the first originator biologics developed have expired, enabling rival products to enter the market. More originator biologics are due to come "off-patent” in the years ahead – according to IQVIA, of the €200 billion worth of pharmaceutical products globally which will lose patent protection between 2021 and 2025, 44% is attributable to biologics. Market growth for biosimilars is therefore expected to be substantial.
NHS England plan to exploit this opportunity. It has identified scope for the NHS to save at least between £400 million and £500m a year by 2020/21 “through increased uptake of the best value biologic medicines, including biosimilars”. To do so it has set out the following:
For NHS England, the competition from biosimilars “creates increased access and choice for patients and clinicians, and enhanced value propositions for individual medicines” , adding that it is “important for the NHS to embed the principles of switching to the best value biological medicine into commissioning and clinical practice, if we are to realise the optimal rate and extent of savings associated with these medicines”.
To further support the development of the UK market for biosimilars, the Medicines and Healthcare Regulatory Agency (MHRA) last year consulted on new guidance to help developers of biosimilars “more clearly understand the requirements for biosimilar products in the UK”.
The MHRA’s now finalised guidance paves the way for biosimilar medicines to gain regulatory approval without the need for a “confirmatory efficacy trial” in most cases, where “sound scientific rationale supports this approach”. Instead, the MHRA will rely on comparative physiochemical data, to show a clear link between structural and functional aspects of the biosimilar and the reference product, and pharmacokinetic studies, to demonstrate bioequivalence. This differs from the regulatory bodies in the EU and US, for instance, where an additional step of a confirmatory efficacy trial will still be required. This promises to speed up the time it takes biosimilar manufacturers to gain a marketing authorisation for their products in the UK, and aligns with the UK government’s objective of building on the country’s already attractive environment for growing life sciences businesses post-Brexit.
Patients are acutely aware of the cost struggles facing the NHS and are increasingly sympathetic to efforts to reduce costs
While the new guidance from NHS England and the MHRA can only help foster growth in the use of biosimilars, there remains an important role for education in driving uptake.
Medicines manufacturers routinely share marketing materials for their products with specialist clinicians to raise awareness of their products, but there is a further need for biosimilar manufacturers to target information more broadly to others involved in prescribing or administering medicines in the healthcare system, as well as patient groups.
Shared decision making between clinicians and patients is an important function of an effective healthcare system. Many patients will be pre-disposed to originator products that have served them well in the past, and healthcare providers will also be more familiar with the medicines that have enjoyed exclusivity in the market.
There is likely to be natural resistance to change, but patient groups at the Westminster Health Forum report that patients are acutely aware of the cost struggles facing the NHS and are increasingly sympathetic to efforts to reduce costs where they understand there is no impact on safety and efficacy and are engaged in the decision of switching. An added bonus is that where patients are involved in shared decision making, this typically also leads to better patient outcomes on the new product and less reported side effects.
A document produced by the NHS in collaboration with the MHRA, NICE and industry bodies, entitled ‘What is a biosimilar medicine?’, is designed to improve the general understanding of biosimilars and their role in supporting both innovation and cost savings in the health system. Biosimilar manufacturers should build on this document by engaging with not only clinical specialists but GPs and practice nurses where appropriate, for instance for products delivered through primary care.
Interaction with patient groups will also be important to ensure they are educated and can partake in shared decision making regarding their treatment with healthcare providers. Such education could explain the comparability of the function, safety and efficacy of biosimilar products to originators, including any benefits and potential side-effects. Further, open discussion to increase understanding of the through testing of biosimilar products to meet regulatory requirements – including the ongoing post-marketing authorisation monitoring that applies – should breed trust and confidence.
As the biosimilar market opens up, the MHRA and NHS has put its best foot forward to help these medicines succeed. Biosimilar manufacturers now need to answer the call to arms by engaging with all stakeholders early so they can achieve market penetration and fully exploit the opportunities that lie ahead.
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