32-33 - Generics and biosimilars: innovation not imitation

George Bernard Shaw might have been thinking about a higher art form than generic medicines when he said those words, but the sentiment applies.

Around 75% of all medicines in the UK are generic, making the UK one of the highest users of prescription generic medicines in Europe. Generics are a cornerstone of the UK health system as they deliver £13 billion in savings every year, according to NHS figures. This is a third of the total NHS medicines bill.

There are some long-term misplaced perceptions that generic medicine prices are subject to arbitrary spikes and that there is much disruption. Fluctuations might have been expected, from a reimbursement perspective, because of the pandemic and other significant events, but monitoring of generic medicine reimbursement prices over the last five years shows the market has been remarkably stable (see Figure 1).

Given the shifts in currency due to global events, impacts from GMP closures, Brexit and the COVID-19 pandemic, the industry has proved remarkably resilient in this challenging environment.

Traditionally generic medicines have been perceived as merely copies of the original products. However, the generics of today are so much more than that.

Yesterday’s blockbuster medicines are becoming today’s generics and biosimilars. For example, Humira (adalimumab) was considered a blockbuster drug (a medicine that reaches the billion-dollar sales mark), when it was approved by the European Medicines Agency (EMA) in 2003. It was the most expensive drug used in NHS hospitals. Since its core patent expired in the US in 2016, and in the EU in 2017, there have been eight biosimilars approved for use by the EMA (as at 20 August 2021). As well as the value reduction due to competition, in June 2021 the National Institute for Health and Care Excellence announced a change to treatment options for up to 25,000 patients with moderate rheumatoid arthritis due to the availability of lower cost biosimilars and supporting treatments. This is a great example of creating cost savings while also increasing access to best-in-class treatments.

What does this mean for the generics industry?
One priority must be to ensure that the industry producing most of the high-volume, everyday medicines, that total more than 1.2 billion packs a year, remains sustainable.
Put simply, for generics companies to be able to launch and develop those specialist medicines, they must have a sustainable base. It is not just a case of levelling up machinery technology. These more complex medicines often have a greater risk/benefit ratio and therefore it is also about building the knowledge and skills to support the additional patient and healthcare materials that are required for the health and safety of the medicine.

As the traditional generics manufacturer model is one of scale, a major challenge for the industry in electing to develop expensive biosimilar medicines is being able to realise that investment and forecast the uptake. It is here that the NHS can be a helpful partner, by communicating the benefits and ensuring uptake, which ultimately benefits the health service through cost savings.

When a medicine patent expires, years of R&D and knowledge about that medicine have been built up. Often the originator pharmaceutical company, having reaped the rewards of that investment, is looking ahead to the next advancement. However, this represents an opportunity for the generics industry. It can build on the knowledge accumulated to develop new formulations, new dosage forms, or devices that deliver the medicine in a more convenient way. Generics companies can add value by making a medicine easier to use, or by providing digital information that improves the experience for the patient.

Patient-centricity is about listening to the needs of patients and working with healthcare professionals to deliver solutions. Without the latter, the solution is unlikely to reach the patient.

A recent example of this approach is a hospital injectable product that was originally developed in a powder form, which, since its patent expiry, has been reconstituted into a ready-to-use solution. That might seem a small incremental innovation, but it makes a huge difference to clinicians by reducing the preparation time required to use the product. As other manufacturers follow suit, it will produce a cost saving that will allow more patients to be treated.

The rise of patient empowerment has resulted in an appetite for information that helps patients better manage their conditions. Creating digital innovation platforms to provide such support used to be the domain of the big originator pharmaceutical companies, but generic companies are entering the space, keen to find more ways to holistically support patients and healthcare professionals.

Such innovations are elevating generic companies and blurring the lines between how generic medicine companies and traditional big pharma are perceived.

Generic medicines companies today have come a long way from 20, or even ten, years ago, but the journey is far from over. There are still challenges that the industry needs to overcome to achieve its vision and potential.

What has become clear is that the balance is shifting and innovation is no longer the mainstay of Big Pharma. The generic medicines industry is undergoing an evolution that is demonstrating innovation on several fronts to benefit both the healthcare professional and the patient.

However, despite the generic medicines industry’s track record for stability and resilience, the focus needs to be on uptake and sustainable policies, to ensure companies can continue to invest in the future pipeline, more complex products and patient-centred medicines.

The NHS has a significant role to play in making this work. Six of the top ten medicines by spend prescribed in NHS hospitals are biological products and, as highlighted earlier, they are committed to ensuring that new and existing patients are prescribed the best value biological medicines. It is in the best interest of the NHS to work closely and proactively with generic manufacturers to bring more affordable biosimilars to the marketplace. By working together, everyone benefits: the manufacturer, the NHS and, most importantly of all, the patients.