GHP Aug 2017

18 GHP / August 2017 , 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. Will Biosimilars Revolutionise the Future of Health? Harriet Lewis, ABPI’s medicines optimisation lead, comments on the future of biosimilars in the UK, asking whether they will revolutionise healthcare. When producing biological medicines, companies must 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 must be able to demonstrate successful reproducibility. Because 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 bio similarity 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 bioavailability 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 pharmacovigilance 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 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 several 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, biosimilars 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