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Biosimilars: embracing innovation and delivering value to patients

Until 20 years ago, most medicines were relatively simple chemical substances. An increasing number of new medicines are very different. They are proteins manufactured by living organisms such as living human, animal or microbial cells, and consist of big, complex molecules.

Biosimilars: embracing innovation and delivering value to patients

This class of medicines is known as biologics or biopharmaceuticals. Whereas “traditional” medicines are synthesised as through a chemical process, biotechnology uses proteins, enzymes, antibodies and other substances that are produced in the human body to create medicines which are far more complex molecules. Figure 1 shows the relative size of biologic molecules compared with simpler chemical molecules. Minor changes in the manufacturing process for biologics, in the environment in which living cells grow for example, can result in subtle changes in molecular structure which may or may not significantly affect the efficacy or safety profile of the resulting medicine. 

Fig 1:

Biosimilars Fig 1 March 2016 NHS London Procurement Partnership

Biological medicines are used to treat various diseases such as cancer, rheumatoid arthritis, psoriasis, Crohn’s disease, renal anaemia and diabetes. These medicines are generally very high cost and place a high burden on healthcare budgets.

Under international law, pharmaceutical companies who develop and market biological medicines have a period of exclusivity of between 10 to 13 years before the patent on the product expires. Recently, several established biological medicines have lost their exclusivity which means other biotechnological companies can manufacture them. When the patent on traditional, small chemical molecule medicines expires, a generic copy can be chemically synthesised to be identical to the original molecule.  This is not the case with biological medicines whose molecular structure may even vary slightly from batch to batch and will inevitably vary from manufacturer to manufacturer. It is therefore not possible to make generic, chemically identical copies of biological medicines.  Biotechnological companies can, though, manufacture a product which is “highly similar” to the original, innovator product known as the “reference” product. Copies of biological medicines   are therefore known as “biosimilars” and can’t be substituted directly for the original product in the same way as generic medicines usually can. One official definition of a Biosimilar is:

“…..a biological medicinal product that contains a version of the active substance of an already authorised original biological medicinal product (reference medicinal product) in the European Economic Area (EEA). Similarity to the reference medicinal product in terms of quality characteristics, biological activity, safety and efficacy based on a comprehensive comparability exercise needs to be established.” (1)

In the same way that generic medicines usually enter the market at a significantly lower price than the original branded medicine, biosimilars generally also have a lower acquisition cost than the innovator products and present major opportunities for healthcare systems to deliver cost efficiencies. The first biosimilar medicines entered the UK market almost 20 years ago but until now the number has been limited. 2015 saw the launch of the first of a very strong pipeline of new biosimilars due to be launched over the next five years with the potential to hugely reduce expenditure on treatment which currently costs the NHS hundreds of millions of pounds annually. The London expenditure on the new pipeline of biosimilars is shown in Table 1. 

Table 1 lists the current and future biosimilar products:

Biosimilar

Reference Product

Availablity

London Secondary Care Expenditure

Infliximab

Remicade®

Licensed Feb 2015

£32m

Etanercept

Enbrel®

Licensed Feb 2016

£35m

Trastuzumab

Herceptin®

Q2 2017

£31m

Rituximab

Mabthera®

Q3 2017

£24m

Adalimumab

Humira®

Q2 2018

£56m

Bevacizumab

Avastin®

Q4 2019

£12m

 

The first of these to become available to the NHS was biosimilar infliximab which was launched in March 2015 at an initial cost (which already shows signs of dropping further) of approximately 40 per cent less than the branded originator Remicade® on which the NHS in London spent £32m in 2015/16.

The regulatory (licensing) process for an innovative requires extensive evidence that a medicine is safe and effective for treatment of specified conditions in specific groups of patients. In the case of biosimilars, provided the manufacturing process has been demonstrated to meet very tight, detailed and comprehensive criteria, the manufacturer is required to show only that the biosimilar is as safe and effective as the reference product in at least one of these conditions and groups of patients. 

Although biosimilars are by definition very similar to the originator reference medicines and have been shown to be equally safe and effective, the fact that they are not identical means that there is a very small chance that widespread use over a period of time may reveal that the incidence and type of side effects such as the likelihood of generating an allergic reaction, is different to the originator medicine. For these reasons, it is important that decisions to start using a new biosimilar are approved though the appropriate trust governance mechanisms, that for individual patients the decision to treat with a biosimilar for the first time or to change treatment to a biosimilar is fully discussed with the patient, that the response to treatment and the patient’s overall wellbeing are especially closely monitored, and that detailed records are kept. Introducing a new biosimilar into clinical practice incurs a very significant extra workload for doctors, nurses and pharmacy staff.  Because most biological medicines and biosimilars are excluded from Tariff, savings on acquisition cost benefit the CCG or NHS England commissioner rather than the provider.  In the last year, providers have argued strongly that the workload of taking on a new biosimilar should be offset by retaining a proportion of the cost saving. Reaching agreement about how this should work has posed a challenge.

Since early 2014, the LPP Medicines Optimisation and Pharmacy Procurement workstream has played a key role in providing clinical, commercial and financial information to provider pharmacy, clinical and finance staff to support planning, in brokering agreement between providers and commissioners about sharing savings, by establishing pan-London contracts for the new agents, and by monitoring and benchmarking uptake and cost avoidance achieved. 

At the end on January 2016, uptake of biosimilar infliximab (Remsima®) averaged approx. 20 per cent across London equating to a cost-avoidance of approximately £2m in 2015-16. Figure 2 shows the aggregated uptake across London trusts and Figure 3 shows the breakdown by trust.

 

Fig 2:

Biosimilars Fig 2 March 2016 NHS London Procurement Partnership

 

Fig 3:

Biosimilars Fig 3 March 2016 NHS London Procurement Partnership

 

March 2016 saw the launch of a second important new agent, biosimilar etanercept on which the NHS in London spent £35 million in 2015/15. LPP’s MOPP team has built on experience gained in 2015 with infliximab. Biosimilar will continue to offer major savings opportunities to the NHS for the next five years at least, and only by capitalising on those savings will the NHS be able to create headroom for the introduction of a whole range of genuinely innovative and potentially highly effective but very high-cost medicines which we already know to be in pharma company development pipelines.

Supporting the managed introduction of new biosimilars will therefore continue to be a major part of the MOPP workstream for some years to come.

How procurement teams can support their organisations to save £20m in 2016/17 by adopting biosimilars: follow the link under 'Supporting Information' on the right.

References:

(1)   Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues. European Medicines Agency 

22-04-16    Pharmacy

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