Will biosimilars revolutionise the future of health?By: Harriet Lewis, Medicines Optimisation Lead of the ABPI

The ABPI represents UK-based pharma companies researching the newest and most innovative medicines. Our members make both originator biological medicines and make biosimilar medicines so, for want of a better word, we have a foot in both camps.

We work to support the introduction of biosimilars but also work to ensure there is a sustainable and active competitive market. To understand why we talk about biosimilars and the biosimilar market in a unique way, it is important to take a step back.

I am a pharmacist - not a scientist - so I am constantly amazed by the science behind biosimilar medicines that is both fascinating and complex. Put simply, biosimilar medicines are made from living cells and since living cells are all slightly different, there are also variations between biosimilar medicines. This so-called heterogeneity is part and parcel of biological medicines: chemical difference that do not affect the clinical effectiveness of the medicine.

When producing biological medicines, companies have to demonstrate the reproducibility of their drugs time-after-time and within certain parameters. Before they even get to the point of clinical trials in humans they have to be able to demonstrate successful reproducibility. As a result of the complexity of manufacturing and regulation, bringing these products to market is time-consuming and expensive.

One of the early keys discussion points around biosimilars is how they should be defined and therefore how they should be treated. Biosimilars are neither generic medicines nor novel treatments. Definitive guidance from the European Commission sets out that they are in fact a "version of an active substance" within an already approved medicine.

Manufacturers must convincingly demonstrate the similar nature of these products. Regulators require biosimilars to demonstrate a comparable clinical effectiveness to originator products. The European Medicines Agency (EMA) goes so far as to say that the 'concept of biosimilarity is applicable to any biological medicinal product'.

Just as with any medicines, there are class-based risks associated with a biosimilar medicine's pharmacology, potency or bioavailabilty over time, and these are monitored on an ongoing basis. Pharmacovigilance is a necessary component to the success of biosimilars and ensures that regulators can trace where biosimilar medicines are used to track immunogenic side effects should they arise.

We can only know so much about any medicine, including biosimilars, before they are licensed. Information and our understanding of how they work in patient populations is continually built-upon once the medicine become available to patients: pre-authorisation clinical studies are often insufficient in highlighting all adverse effects. Across Europe, the pharmacovigilence Regulation requires that all adverse events for biologics are reported by brand name and batch number. In England, prescribers are encouraged to prescribe by brand name and NHS providers to record product name and batch number in order to provide an audit trial for product identification and traceability.

The impact of biosimilar competition and what comes next

The European biosimilars market has grown exponentially since the first medicine was launched back in 2006; there was a sudden uptick from 2012 and if you look at any timeline outlining the number of medicines launched what is abundantly clear among the many successes are also a number of failures.

Once you have started manufacturing a biosimilar medicine, it isn't a done deal that you'll have a successful medicine. In that respect, biosimiliars are indistinguishable from originator products.

There are also strict regulatory challenges for biosimilar medicines and regulators take time to assess and approve them. This is unlike generic medicines, which are often licensed relatively quickly and are made available to patients on much shorter timescales.

While we are seeing a fast-growing market in biosimilars in all areas, it is also becoming apparent that they might not always be commercially viable.

It has become clear from the rapid expansion of the biosimilars market, according to the QuintilesIMS European study 'The Impact of Biosimilar Competition in Europe', competition drives down price. The report also shows there is a relatively weak correlation between biosimilars market share and price; this is a fast growing market that will inevitably provide complex medicines at more affordable prices, switching to biosimilar medicines may release savings in health systems that should be reinvested in patient care and not used to plug financial deficits.

"Switching may r?elease savings that should be reinvested in improving patient access to innovative medicines."?

We know that switching from originator projects to biosimilars is being heralded by NHS as the next step in delivering savings to health systems, although the predicted savings on the scale suggested have yet to be delivered. Actually, it's not switching per se but the introduction of competition, in which both the biosimilar producers and originator biologic manufacturers compete (as the IMS Health study has demonstrated). Regardless, the decision to switch should be clinically-led: considerations must be made to ensure patient access to innovative new medicines and that those are made between patients, clinicians and doctors.

There is also a burden associated with switching to biosimilar medicines both in the financial sense but also as a burden on the clinical support staff that need to manage the change. Education is a key part of these decisions. To support clinicians considering switch programmes there are a number of important documents setting out the process for clinician and patient engagement , including "Considerations for physicians on switching decisions regarding biosimilars" a joint document from European Biopharmaceutical Enterprises (EBE) European Federation of Pharmaceutical Industries and Associations (EFPIA) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) [link below] , but also on the EMA website, to show clinicians some of these toolkits available to make informed decisions about switching.

As ABPI we are working closely with our partners: the BIA, the BGMA and the BBA, as well as the regulators, to make sure that we have a sustainable and active market so that patients do actually benefit from the innovation seen in this growing field of medicines.

We continue to work closely with NHS England on a range of activities to highlight how competition within the biologics market is beneficial for patients. The ABPI recently advised on a forthcoming NHS commissioning framework document which will provide guidance to NHS commissioners about biosimilar switching programmes. We look forward to seeing the final version and hope that our industry's insight has been considered and that the benefits to patients of an effective biosimilars market here in the UK are included.

The phenomenally complex manufacturing process involved in making biosimilars is really leading contemporary science in this field and could potentially revolutionise the treatment of some conditions. 

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