Infliximab launch is milestone in development of UK biosimilars industry

The UK patent on the product expired yesterday and today (25 February 2015) biosimilar Infliximab products are launching which will be available to NHS clinicians and patients under separate brand names. 

These are the first biosimilar launches since NICE updated its methods for providing guidance and advice on biosimilar medicines earlier this year.

Warwick Smith, Director General of the BGMA, said: “In our view 2015 represents a breakthrough year for biosimilars and the launch of biosimilar Infliximab products will be the start of a sea-change in their use. NICE has acknowledged that biosimilars have the potential to offer the NHS considerable cost savings, especially as they are often used to treat long-term conditions.

“This will enable the NHS to treat more patients with these life-changing products. Moving forward, in order to derive the most patient benefit, we need to ensure that the appropriate mechanisms are in place which allow regulators, clinicians and payors to best utilise these medicines for their patients.”

A biosimilar medicine is developed to be similar to an existing biological product. 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.