Biologics are produced by a complex process involving living organisms. They have revolutionised the treatment and prevention of many disabling and life-threatening diseases: diabetes, psoriasis, arthritis, growth disorders, inflammatory digestive disorders and certain types of cancer. Many of the medicines used in the NHS today, especially those at the forefront of care, are biological medicines. Biologics are much larger than the chemically-synthesised small molecule medicines that still represent the majority of medicines.
However, biologics are contributing to the rising costs of healthcare, and this may restrict access to these important medicines.
A biosimilar is an approved biologic with comparable quality, safety and efficacy to an approved reference product. They are approved via stringent regulatory pathways (in highly regulated markets such as the EU, US, Japan, Canada and Australia) following loss of exclusivity of their originator reference products.
In other words, a biosimilar must be so similar to the reference biologic that statistically-speaking you cannot tell the two apart in terms of ability to treat the disease (efficacy), safety profile and overall quality: the three things that matter the most to doctors and patients. This means that biosimilars are expected to provide the same clinical benefits as the originator biologic.
Biosimilar medicines have the potential to address patient access challenges, generate cost savings for healthcare systems and increase treatment options for healthcare professionals (HCPs).
Sandoz is committed to increasing patient access to high-quality biosimilars. It is the pioneer and global leader in biosimilars, with two marketed products in the UK: Omnitrope® and Zarzio®.
With a leading pipeline, Sandoz plans to launch five biosimilars of major oncology and immunology biologics across key geographies by 2020. Sandoz’s early- stage pipeline has additional assets in oncology as well as other specialty therapeutic areas with plans to start new programs every year.
Sandoz is a Biosimilars pioneer with the first approved Biosimilar in both Europe and the US and is the global Biosimilars leader with >50% global market share. All Sandoz biosimilars in the EU are approved centrally by the European Medicines Agency (EMA) and are closely monitored through the Sandoz Global Pharmacovigilance System.
As a division of the Novartis Group, Sandoz is well-positioned to lead the biosimilars industry based on its experience and capabilities in development, manufacturing and commercialisation.
Biosimilars have been on the market in Europe and other parts of the world since 2006 and have generated hundreds of millions of patient days of real world clinical experience, in which biosimilars had similar outcomes to the reference product.
Job Number: UK/MKT/SDZ/17-0035 Date of preparation: 21st April 2017