Adalimumab biosimilars launched as Humira ® patent expires

hands holding matching drug containers to show adalimumab biosimilars

As the Humira ® patent expires, a number of adalimumab biosimilars have been launched in the UK and across Europe. At the same time, NHS England Chief Executive, Simon Stevens has asked doctors to also consider equally effective, safe, ‘biosimilar’ versions of Adalimumab after the Humira ® patent expired on Tuesday 16th October.

NHS England says that Adalimumab is the single medicine on which hospitals spend the most, at a cost of more than £400 million a year. Adding that more than 46,000 patients are prescribed the drug, which was only available under the brand name Humira®, for hospital treated, serious conditions such as rheumatoid arthritis, inflammatory bowel disease and psoriasis.

NHS England has issued guidance to trusts and clinical commissioning groups telling them that nine out of 10 new patients should be started on the best value medicine within three months of a biosimilar launch. Adding that at least 80% of existing patients should be switched to the best value biologic (which could be the originator or a biosimilar) within 12 months.

Following the patent expiry, a number of adalimumab biosimilars have been launched.

Amgen announced the launch of AMGEVITA®, a biosimilar to adalimumab, in markets across Europe. AMGEVITA is authorised for the treatment of inflammatory diseases in adults and is also authorised for the treatment of paediatric inflammatory diseases. It is the first inflammation biosimilar from Amgen’s portfolio to launch in Europe.

Sandoz, a Novartis division, also announced that Hyrimoz® (adalimumab) the Sandoz biosimilar of Humira®, is available for patients in the UK. Hyrimoz® is the fifth Sandoz biosimilar available for use in the UK.

Samsung Bioepis Co. Ltd, a joint venture between Samsung BioLogics and Biogen has also announced the European launch of IMRALDITM, an adalimumab biosimilar referencing Humira®. The launch of IMRALDI completes Biogen’s portfolio of three anti-TNF biosimilars in Europe.

Simon Stevens said of the use of biosimilars: “Biosimilar versions of widely used, expensive drugs are already delivering safe, effective treatment for patients across the NHS, including those with cancer.

“Adalimumab is the NHS’s biggest spend on a single drug and, as the NHS develops the long-term plan, we want more clinicians to switch to use the best value biologics which will free up hundreds of millions of pounds to reinvest back into patient care.”