The United Kingdom is a global leader in adopting biosimilar and generic medicines, which deliver major National Health Service savings and expand patient access to effective treatments sooner.

We are working with the Medicines and Healthcare products Regulatory Agency, the National Institute for Health and Care Excellence (NICE), and NHS England to understand forthcoming biosimilars and to ensure they reach the frontline efficiently. Through NHS England’s Best Value Biologicals Framework, clinicians start patients on the most cost‑effective biologics where appropriate, and switches are made swiftly and safely. This has already delivered £1.2 billion in savings over the past three years.

As set out in the 10‑Year Health Plan and Life Sciences Sector Plan, we are streamlining regulation, improving procurement, and reducing variation in uptake. NICE’s whole‑lifecycle approach ensures clinical pathways are regularly reviewed so that patients benefit as soon as cost‑effective generics and biosimilars become available, as seen in recent cancer treatments. These actions support timely access to effective off‑patent medicines and a sustainable, competitive market for the NHS.

The United Kingdom’s world leading life sciences sector is central to our Industrial Strategy, driving growth, investment, and high-quality jobs. As set out in the Life Sciences Sector Plan, which we developed while working closely with the sector, there is an opportunity for the National Health Service to save £1 billion over five years through biosimilars uptake, delivering value for patients and the NHS. The Life Sciences Council is an important forum that brings together senior industry and Government leaders to shape the sector’s future. The Government remains committed to this partnership and is looking to convene the council in due course.

Medicines UK and its members are represented on the Single National Formulary Industry Task and Finish Group. In addition, the Government is working to convene further task and finish groups to drive forward defined areas of the Life Sciences Sector Plan, including in the generic and biosimilars space. These groups will direct focused ministerial and official attention toward a clear set of priorities and will work closely with industry to deliver tangible progress within a set timeframe.

The United Kingdom’s world leading life sciences sector is central to our Industrial Strategy, driving growth, investment, and high-quality jobs. As set out in the Life Sciences Sector Plan, which we developed while working closely with the sector, there is an opportunity for the National Health Service to save £1 billion over five years through biosimilars uptake, delivering value for patients and the NHS. The Life Sciences Council is an important forum that brings together senior industry and Government leaders to shape the sector’s future. The Government remains committed to this partnership and is looking to convene the council in due course.

Medicines UK and its members are represented on the Single National Formulary Industry Task and Finish Group. In addition, the Government is working to convene further task and finish groups to drive forward defined areas of the Life Sciences Sector Plan, including in the generic and biosimilars space. These groups will direct focused ministerial and official attention toward a clear set of priorities and will work closely with industry to deliver tangible progress within a set timeframe.

The United Kingdom’s world leading life sciences sector is central to our Industrial Strategy, driving growth, investment, and high-quality jobs. As set out in the Life Sciences Sector Plan, which we developed while working closely with the sector, there is an opportunity for the National Health Service to save £1 billion over five years through biosimilars uptake, delivering value for patients and the NHS. The Life Sciences Council is an important forum that brings together senior industry and Government leaders to shape the sector’s future. The Government remains committed to this partnership and is looking to convene the council in due course.

Medicines UK and its members are represented on the Single National Formulary Industry Task and Finish Group. In addition, the Government is working to convene further task and finish groups to drive forward defined areas of the Life Sciences Sector Plan, including in the generic and biosimilars space. These groups will direct focused ministerial and official attention toward a clear set of priorities and will work closely with industry to deliver tangible progress within a set timeframe.

The Department has made no assessment. NHS Improvement holds a joint role in supporting the National Health Service to use the best value biologic medicine which is part of a long standing programme of work connected to the NHS Biosimilar Medicines Steering Group, the NHS England Medicines Value Programme and the NHS Improvement Top 10 Medicines remit.

The Biosimilars Medicines Steering Group is intended to ensure appropriate use of biosimilar medicines across the NHS in England. This includes a focus on the importance of shared decision making and patient consent. The steering group has produced commissioning guidance which sets out best practice in shared decision making and which is fully endorsed by patient groups.

NHS England has issued guidance around the commissioning of biological medicines and expects clinical commissioning groups (CCGs) to give due consideration to this guidance. The Commissioning Framework sets out the importance of developing local policies to support switching patients to biosimilars in line with best practice, but ultimately CCGs and hospital trusts are accountable for their own local decision making.

All National Health Service organisations have a responsibility to encourage a shift in moving to shared decision making, and in ensuring that all patient consultations are done with a focus on shared decision making, and are happening at an individual healthcare professional/patient level. NHS England has also made clear that the decision to prescribe a biological medicine for an individual patient, whether an originator or biosimilar, or to change between the two, rests with the responsible prescriber in consultation with the patient, in line with the principles of shared decision making.

Uptake of best value biological medicines is monitored and measured via the NHS Improvement Model Hospital Dashboard. The Regional Medicines Optimisation Committee’s (RMOC) role is to review regional variation, understand the reasons for it and signpost outliers to implementation tools/guidance to support increased uptake. The RMOC work on best value biological medicines is done so in line with the shared care principles set out in the Commissioning Framework for best value biological medicines, including biosimilar medicines.

NHS England has issued guidance around the commissioning of biological medicines and expects clinical commissioning groups (CCGs) to give due consideration to this guidance. The Commissioning Framework sets out the importance of developing local policies to support switching patients to biosimilars in line with best practice, but ultimately CCGs and hospital trusts are accountable for their own local decision making.

All National Health Service organisations have a responsibility to encourage a shift in moving to shared decision making, and in ensuring that all patient consultations are done with a focus on shared decision making, and are happening at an individual healthcare professional/patient level. NHS England has also made clear that the decision to prescribe a biological medicine for an individual patient, whether an originator or biosimilar, or to change between the two, rests with the responsible prescriber in consultation with the patient, in line with the principles of shared decision making.

Uptake of best value biological medicines is monitored and measured via the NHS Improvement Model Hospital Dashboard. The Regional Medicines Optimisation Committee’s (RMOC) role is to review regional variation, understand the reasons for it and signpost outliers to implementation tools/guidance to support increased uptake. The RMOC work on best value biological medicines is done so in line with the shared care principles set out in the Commissioning Framework for best value biological medicines, including biosimilar medicines.

There are no current plans to make bio-identical hormone replacement therapy routinely available on National Health Service prescription. The Medicines and Healthcare products Regulatory Agency (MHRA) is the Agency responsible for the regulation of medicines used in the United Kingdom. There is a clear regime in place, administered by the MHRA, to enable medicines to be developed, authorised (licensed) and made available to patients in the UK. It is important that authorised medicines meet rigorous standards so that doctors and patients are sure of their quality, efficacy and safety.

I refer the hon. Member to the answer I gave to the hon. Member for Glasgow South West (Chris Stephens MP) on 14 February 2019 to Question 219498.

NHS England has issued guidance around the commissioning of biological medicines and expects clinical commissioning groups (CCGs) to give due consideration to this guidance. The framework sets out the importance of developing local policies to support switching patients to biosimilars in line with best practice and where appropriate. The commissioning framework set out policy based on best practice but ultimately CCGs and hospital trusts are accountable for their own local decision making.

All National Health Service organisations have a responsibility to encourage a shift in moving to shared decision making, and in ensuring that all patient consultations are done with a focus on shared decision making, and are happening at an individual healthcare professional/patient level.

NHS England has also made clear that the decision to prescribe a biological medicine for an individual patient, whether an originator or biosimilar, or to change between the two, rests with the responsible prescriber in consultation with the patient, in line with the principles of shared decision making.

NHS England has issued guidance around the commissioning of biological medicines and expects clinical commissioning groups (CCGs) to give due consideration to this guidance. The framework sets out the importance of developing local policies to support switching patients to biosimilars in line with best practice and where appropriate. The commissioning framework set out policy based on best practice but ultimately CCGs and hospital trusts are accountable for their own local decision making.

All National Health Service organisations have a responsibility to encourage a shift in moving to shared decision making, and in ensuring that all patient consultations are done with a focus on shared decision making, and are happening at an individual healthcare professional/patient level.

NHS England has also made clear that the decision to prescribe a biological medicine for an individual patient, whether an originator or biosimilar, or to change between the two, rests with the responsible prescriber in consultation with the patient, in line with the principles of shared decision making.

NHS England has issued guidance around the commissioning of biological medicines and expects clinical commissioning groups (CCGs) to give due consideration to this guidance. The framework sets out the importance of developing local policies to support switching patients to biosimilars in line with best practice and where appropriate. The commissioning framework set out policy based on best practice but ultimately CCGs and hospital trusts are accountable for their own local decision making.

All National Health Service organisations have a responsibility to encourage a shift in moving to shared decision making, and in ensuring that all patient consultations are done with a focus on shared decision making, and are happening at an individual healthcare professional/patient level.

NHS England has also made clear that the decision to prescribe a biological medicine for an individual patient, whether an originator or biosimilar, or to change between the two, rests with the responsible prescriber in consultation with the patient, in line with the principles of shared decision making.

NHS England has issued guidance around the commissioning of biological medicines and expects clinical commissioning groups (CCGs) to give due consideration to this guidance. The framework sets out the importance of developing local policies to support switching patients to biosimilars in line with best practice and where appropriate. The commissioning framework set out policy based on best practice but ultimately CCGs and hospital trusts are accountable for their own local decision making.

All National Health Service organisations have a responsibility to encourage a shift in moving to shared decision making, and in ensuring that all patient consultations are done with a focus on shared decision making, and are happening at an individual healthcare professional/patient level.

NHS England has also made clear that the decision to prescribe a biological medicine for an individual patient, whether an originator or biosimilar, or to change between the two, rests with the responsible prescriber in consultation with the patient, in line with the principles of shared decision making.

NHS Improvement does not monitor use of shared decision making. It instead monitors uptake of the biosimilars as against the original – usually patented – medicines.

It does, however, hold a joint role in supporting the National Health Service to use the best value biologic medicine which is part of a long standing programme of work connected to the NHS Biosimilar Medicines Programme Board, the NHS England Medicines Value Programme and the NHS Improvement Top 10 Medicines remit.

The biosimilars medicines programme board is intended to ensure appropriate use of biosimilar medicines across the NHS in England. This includes shared decision making and patient consent and the board has produced guidance which sets out the importance of shared decision making which is fully endorsed by patient groups.

The Department has had no such discussions. We are informed by NHS England that discussions with biosimilar companies are ongoing and, as of yet, have no definitive date for launch of any of the biosimilar trastuzumab products. Once it is known when companies are likely to launch, NHS England can then look at a timetable for implementation.

A final date for the availability of a biosimilar of Herceptin (trastuzumab) has yet to be agreed. Therefore NHS England has not yet issued any guidance on the introduction of a biosimilar of Herceptin (trastuzumab) for breast cancer. However, NHS England has discussed the introduction and uptake of biosimilar trastuzumab with the Cancer Vanguard. The Vanguard is a group of National Health Service trusts looking at developing new models of care and providing replicable models for cancer care nationally that will act as blueprints for the NHS.

The Cancer Vanguard will provide guidance and supporting documentation to hospital trusts and clinicians in the same way that documents were provided to support the introduction of biosimilar rituximab. Once a firm date is known, NHS trusts will be contacted regarding the availability of biosimilar trastuzumab and what they must do to ensure uptake. This will include linkages to the supporting documents issued by the Vanguard.

NHS England is working closely with the Cancer Vanguard and the Chemotherapy Clinical Reference Group to ensure all stakeholders, including charities and patient groups, are involved with the implementation of biosimilar trastuzumab.