Here at our Leeds clinic, there’s another huge study coming our way. Over the next few months, we’ll be enrolling 240 healthy men and women aged 18-55 including smokers of up to 10 cigarettes per day to help us test a potential new treatment for Rheumatoid Arthritis. I’ve written about this chronic and debilitating illness before in this blog post, and it left me in no doubt that a solution for RA must be found. But what’s so special about this particular study drug?
Well, to be honest… at first I found that question quite difficult to answer!
The drug is what’s known as a biosimilar. This means it is meant to closely resemble another drug, one which is already licensed and available. So, a copy then? It’s not quite that simple.
To understand a biosimilar, we must first look at a class of drugs called biologics. Unlike a typical drug which is created by mixing chemicals, a biologic is a drug containing ingredients which were manufactured inside a living cell. Often, synthetic DNA created in a lab is used to produce biologic ingredients.
In recent years biologic drugs have revolutionised the way we treat a huge range of illnesses, including cancer, heart disease, skin conditions like eczema and psoriasis, and rheumatoid arthritis. However, creating an effective biologic is no easy task. Creating a biologic drug is sometimes compared to making wine – temperature, variety of grape, location, soil quality, rainfall, all make a huge difference to the finished product. Like our grapes, biologic ingredients are unpredictable, and their effectiveness depends on a massive range of factors.
The result? Biologic drugs take many years to develop, and the cost is nothing short of astronomical. The reality is that this expense is passed on to patients and to healthcare trusts. Biologic treatment costs in the region of £2500-3000 per month, and when many of the patients who rely on it have incurable chronic conditions, this cost mounts up very quickly! The sad fact is it’s too expensive to prescribe biologics to everyone who could benefit from them. They are usually offered when an illness has progressed and nothing else works.
So – the patent expires on a biologic, another company copies the idea and sells it much cheaper? Right? Um, no.
When the patent runs out on a typical drug, rival companies can easily access the chemical ‘recipe’ and recreate the drug without incurring the costs of research and development (this is why you can buy paracetamol from the supermarket so cheaply!). But remember we said that biologics are a bit like wine? Developing a biosimilar is a bit like trying to recreate a bottle of wine as closely as possible – same grapes, same weather, same location- and working all of this out just by tasting the wine. Like creating the original drug, it requires a shedload of skill, patience, and money.
Developing a biosimilar is no ‘easy way out’ for a pharmaceutical company. The time, energy and cost of creating a biosimilar is tremendous – but any saving which can be made by creating biosimilars is an advantage, and will lead to the drug becoming more accessible to the patients who need it.
If you’d like to help us develop a biosimilar which could benefit thousands of Rheumatoid Arthritis patients and earn from £100 per day, apply now to become a clinical trials volunteer.