Table 1.

A non-exhaustive overview of policy measures and recommendations related to biosimilars in England

Year	Details
2015 and 2019	In September 2015, NHS England published an information guide (‘What is a biosimilar medicine?’) with the aim to educate stakeholders on the role of biosimilars [51]. This guide was created in collaboration with industry and pharmacists’ associations, and regulatory and health technology assessment (HTA) authorities. An update was published in May 2019, also involving a patient organisation for rheumatoid arthritis patients and clinicians (via the Biosimilars Programme Board) [52].
2015–2018	The National Institute for Health and Care Excellence (NICE), England’s HTA body, had updated already in 2015 its guidelines for evaluation of biosimilars [53]. In addition, from 2016 to 2018, NICE provided updates on the information and evidence available for adoption of biosimilars within NHS England [54], and has published specific medicines evidence commentaries on, for example, bioequivalence between biosimilar and reference TNF-α inhibitors in 2017 [55].
2017	In September 2017, NHS England published its Commissioning framework for biological medicines (including biosimilars medicines), which urges commissioners to leverage competition from biosimilars via a collaborative approach and sets out a target of at least 90% of new patients on the best value biological medicine within 3 months after the entry of a biosimilar [2]. When choosing a best value biological medicine, which can be either the biosimilar or the originator depending on the offer, an evaluation needs to be carried out of “transparently costed device training, any patient support programs offered by manufacturers, administration costs, dosage and price per dose” [2]. Furthermore, at least 80% of existing patients should be switched to the best value biological product within 12 months after the entry of the biosimilar. When this target is not reached, commissioners will have to provide justification. For hospitals, these targets are linked to a financial incentive through a Commissioning for Quality and Innovation (CQUIN) scheme [56].
2017	To ensure local implementation, biosimilars have been taken up by the Regional Medicines Optimisation Committees (RMOCs). Four RMOCs that cover London, the South, the North, and the Midlands and East of England started in 2017 targeted with reducing variation in the optimal use of medicines between regions and aligning local implementation of national policy measures [57]. Regional procurement pharmacists try to align national and regional policy and facilitate implementation by, for example, highlighting to trusts what the potential savings are and producing reports to demonstrate this.
2017	In 2017, the Cancer Vanguard, a part of the NHS established to follow up their National Cancer Strategy [58], developed in collaboration with Sandoz an interactive document with a proposed biosimilar adoption process timeline, including educational and supporting material for switching patients. The timeline flowchart initially aimed to facilitate the introduction of rituximab biosimilars in 2017, but is highly relevant for other therapeutic areas [59].
2018	In 2018, with the upcoming loss of exclusivity of originator adalimumab in mind, a national biosimilars programme board was created, consisting of hospital clinicians, pharmacists, procurement pharmacists, nurses, patient associations, authorities and industry (both biosimilar and originator), and is chaired by NHS England’s Chief Pharmaceutical Officer. This board aims to drive biosimilar use by advising NHS England.