6 Janauary 2015 - NICE has updated its methods for providing guidance and advice on biosimilar medicines, as their availability and use on the NHS grows.

A biosimilar medicine is a medicine that is developed to be similar to an existing biological medicine. Biological medicines are produced in or derived from living systems, and are made up of proteins, sugars or nucleic acids.

They differ from generic drugs which have simpler chemical structures and are considered to be identical to their reference medicines. The characteristics of biologic drugs cannot be reproduced exactly.  

To gain approval for use, biosimilar medicines have to demonstrate that they are as safe and as effective as the original reference medicine, and have the same quality.

Over the past 10 years there has been a rapid worldwide increase in the number of biological medicines that have received regulatory approval.

Biosimilar medicines are developed in anticipation of an impending patent expiry of innovator biologic drugs.

A number of top-selling biological medicines have lost, or will be losing patent protection over the next few years, especially monoclonal antibodies that are tumour necrosis factor (TNF) inhibitors or receptor antagonists for use in patients with cancer, rheumatoid arthritis and other inflammatory disease, and insulins for diabetes.

Although biosimilars are already used to some extent in the NHS, and NICE has previously included biosimilars in its  technology appraisal on  the human growth hormone (somatropin), it is likely that their availability and use will become more widespread over the next few years.

Biosimilars have the potential to offer the NHS considerable cost savings, especially as they are often used to treat long-term conditions.

Therefore NICE’s position and process for developing guidance and advice for these medicines has been reviewed.

For more details, go to: https://www.nice.org.uk/news/article/evaluating-biosimilar-medicines