Definition of a biosimilar medicine
A biosimilar medicine is a biological medicine which has been shown not to have any clinically meaningful differences from the originator medicine in terms of quality, safety and efficacy. Where NICE has already recommended the originator biological medicine, the same guidance will normally apply to a biosimilar of that originator.
The NHS is bringing a new generation of biosimilar medicines to the fore for patients, giving greater access to important treatments for thousands of hospital patients with serious conditions and providing increased value for the NHS.
Biological medicines are currently the largest cost and cost growth areas in the NHS medicines budget. Using a new commissioning framework, NHS England aims to drive a step change in the uptake of biosimilar medicines by clinical commissioning groups (CCGs), who commission hospital trusts to provide the treatment, and make sure patients are offered the choice of switching to a new product by their specialist hospital doctor.
Through making biosimilar medicines more quickly available the NHS will by 2021 be able to take advantage of up to £300m of savings each year offered by these new products, enabling more patients to have access to other life-saving and life-enhancing treatments.
NHS Improvement is supporting the increased uptake of biosimilar medicines though the launch of its Top 10 Medicines Dashboard in July 2017. This follows from the Recommendations of Lord Carter’s 2016 report and is linked to the Model Hospital where the majority of NHS acute trusts will be able to review their potential savings opportunities for an initial group of 10 drugs, three of which are biosimilar products.
Complex biological medicines are an increasingly significant component of the therapeutic options available across Europe, and until recently often there has been just one original product available – contributing to a situation that six of the top 10 medicines by spend prescribed in NHS hospitals are biological products.
Biosimilar medicines are biological medicines which are highly similar to another biological medicine already licensed for use. To be licensed by the European Commission on the advice of the European Medicines Agency (EMA), a biosimilar medicine must be shown to have no clinically meaningful differences from the originator medicine in terms of quality, safety and efficacy. However, biosimilar medicines are not the same as generic medicines, which contain simpler chemical structures and whose active ingredients are identical in terms of molecular structure to their reference medicines. Where NICE has already recommended the originator biological medicine, the same guidance will normally apply to a biosimilar of that originator.
The decision to prescribe a biological medicine for an individual patient, whether an originator or biosimilar medicine, rests with the responsible clinician in consultation with the patient. CCGs, hospital trusts and Regional Medicines Optimisation Committees will need to work together to apply this guidance in local areas. Doctors will always consult with patients and their families/carers about any switching; which is a clinical decision. NHS England will be working closely with patient groups over the coming months to explain about biosimilars.
The biological medicines market will increase in complexity over the coming months and years as more biological medicines lose patent exclusivity and additional biosimilar medicines come to market. NHS England’s Biological Medicines Commissioning Framework, Including Biosimilar Medicines is a timely response in anticipation of this new generation of biosimilars.