This post originally appeared on the BioOutsource blog
Biosimilars challenge us in many ways; these issues can be divided into three groups: challenges faced by scientists, challenges faced by industry and challenges faced by patients.
In my job, as a CSO working in Contract Research, I have found biosimilars have forced us to better understand the biological aspects of these drugs. In the past a monoclonal antibody was considered characterised when we had shown binding to the target, little more.
The true mode of action of how these drugs worked on the disease is still, in many cases, poorly understood. With the introduction of Biosimilars we needed to understand the behaviour of these very complicated drugs and how changes to the molecules resulted in differences in efficacy. This is important, as the ultimate aim is to prove we can make a molecule with the same potency for all indications.
To use the arthritis drug Humira as an example, this drug has been used for over 12 years with an annual turnover of close to 10 billion dollars. First approved for arthritis its indication spread and is now common for the treatment of Crohns disease, ulcerative colitis and psoriasis. The drugs primary mechanism of action in each disease is slightly different, so the way the drug calms the inflammation relieving arthritis is different to how it helps relieves the symptoms of Crohns. We are still learning how this long approved drug works in the body, driven by some of the biosimilar studies carried out. For a biosimilar however, this complicates matters hugely, increasing the variety of methods we need to use to show comparability.
Those of us involved in making biologic drugs understand that by using living cells the consistency of the end product would never be the same as small molecule drugs. Batch to batch variability was recognised and accepted, changes to the manufacturing process resulted in minor but measurable changes to the product – these were again seen as part of the issues with these drugs but for Biosimilars when does variability end and we need to consider the drug different?
The biosimilars challenge to industry is threefold: speed to market, cost of goods and production facilities. Manufactures see the market opportunity – there are 10 blockbusters ready to come off patent, a market worth over 50 billion dollars. Read the rest of the blog here