What are mAbs biosimilars?

4/7/2016

An introduction to biosimilars and monoclonal antibodies (mAbs)
 
The purpose of this second post is to provide a simplified yet accurate introduction to biosimilars.
 
The first thing to know is that biosimilars are biological drugs. And now you are wondering: What are biological drugs? These drugs encompass any substances used to treat a disease that are solely and exclusively extracted from humans.
 
A biosimilar medicine is a medicinal product of biological origin that is produced in a living organism following a procedure equivalent to a biological drug and adhering to the same quality criteria, hence the name biosimilars. In short, they are biological drugs that are “equivalent” in terms of quality, efficacy and safety to an innovative reference medicinal product.
 
But if we are sceptical of “copies” in other sectors, such as food, why should we trust a medical copy? Who ensures that these medicines really are “equivalent” and have the same effects as biological drugs? Firstly, we are not talking about simple copies. Secondly, assurance is provided by the fact that biosimilars are produced in compliance with the specific requirements dictated by the two biggest drug regulatory bodies: the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). These requirements certify that the quality, efficacy and safety of biosimilars is comparable to the innovative reference medicinal product; i.e., the biological drug on which the biosimilar is “based”.
 
Why are biosimilars important?
 
Biosimilars are destined to play a key role in the treatment of many diseases, not least of which is cancer, a disease that affects us all, whether directly or indirectly. According to the Spanish Society of Medical Oncology (SEOM), in Spain alone, the number of new cases of cancerous tumours is expected to reach 246,713 by 2020.
 
In light of this bleak outlook, biosimilars are going to have a key role to play. They are used mainly in the fields of oncology, autoimmune diseases and haematology. In addition, their low market price will make them much more affordable to healthcare systems. Can you imagine what this could mean for cancer patients?
 
Biosimilar monoclonal antibodies (mAbs) are part of the biosimilar family. They are large, complex proteins used by the immune system to identify and neutralise foreign bodies, such as bacteria, viruses, etc., and are usually administered in the treatment of diseases like cancer or rheumatoid arthritis. In layman’s terms, mAbs could be seen as “weapons” or “shields” used by the immune system to fight the aforementioned diseases.
 
Paradoxically, although biosimilars have been available on the European market since 2003, when the EMA assumed the role of European regulator in this field, people’s awareness of them is extremely limited. What is more, although hard to believe, Spain is the sixth largest market for biosimilars in Europe, which highlights the need to raise awareness of the ever more important role of biosimilars not just in Spain, but all over the world. Want to find out more? Keep a look out for our next post…