The United Kingdom’s National Health Service (NHS) has published a new document for clinical and nonclinical stakeholders about the role of biosimilars in the healthcare system. The guidance document, says the NHS, is intended to support the safe, effective, consistent use of biologics, including biosimilars, to the benefit of patients.
The United Kingdom’s National Health Service (NHS) has published a new document for clinical and nonclinical stakeholders about the role of biosimilars in the healthcare system. The guidance document, says the NHS, is intended to support the safe, effective, consistent use of biologics, including biosimilars, to the benefit of patients.
In the document, the NHS explains that, by 2021, through the use of the best-value biologics, the NHS can save at least £400 million to £500 million (US $508 million to $635 million) per year. Maximizing the value of the medicines for which the NHS pays will allow the NHS to produce “much-needed headroom” for funding innovative treatments and improving pathways of care.
The guidance explains such concepts as the inherent variability in the structure of all biologics, the difference between generics and biosimilars, the extrapolation of indications, and the European approval pathway for biosimilars.
It also explains that in cases in which the nation’s health technology assessment body, the National Institute for Health and Care Excellence (NICE), has already recommended use of the reference product, the same guidance will typically apply to the biosimilar.
It also highlights the fact that prescribers can switch patients from the reference to a biosimilar, and the decision of which product to prescribe rests with the prescriber in consultation with the patient. “Biosimilar products are considered to be interchangeable with their reference product; which means a prescriber can choose the biosimilar medicine over the reference product (or vice versa) and expect to achieve the same clinical effect,” the guidance notes. Pharmacy-level substitution is not permitted without consultation with the prescriber for any type of biologic, including biosimilars.
In keeping with national guidance and EU law, all biologics should be prescribed by brand name, not by international nonproprietary name, it adds. This practice should ensure that unintended substitution does not take place. Any adverse event should be reported using the brand name and specific batch number. Brand and batch information should also be provided to patients when products are administered to help them to report any issues accurately.
The guidance document is an update to 2015 guidance on biosimilars, and it was prepared in partnership with such stakeholders as the Association of the British Pharmaceutical Industry, the British Biosimilars Association, NICE, and the National Rheumatoid Arthritis Society, among others.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Hesitancy in MENA Nations to Adopt WHO Biosimilar Guidelines Hinders Market Development
July 17th 2024The World Health Organization’s (WHO) new guidelines for biosimilar approvals aim to save time and money for manufacturers in the Middle East and North Africa (MENA), but hesitancy among nations to adopt the guidelines is stifling market development of biosimilars.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.