Current Challenges and Opportunities in Cost Effective and Affordable Biosimilars
27th October 2014
By: Dr Daniel Galbraith, CSO,
Biosimilars challenge us in many ways but for me these issues can be divided into those for a scientist, those for the industry and those for the patient.
In my job, as a CSO working in Contract Research Organization, 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. With the European patent expiring already for some and the rest in just a few years there is the race to be the first to market.
Europe already expects Biosimilars to be at least 30% cheaper that the original, many emerging markets expect the cost to be even less. This creates a huge challenge for our suppliers and manufacturers to reduce costs. One big hurdle we have is finding a production facility to manufacture enough material to supply even a portion of the demand. Data from Europe for the early Biosimilars – Filgrastin and EPO has already shown that when prices reduce clinicians prescribe more, creating more demand for product. This coupled with the emerging markets tells us we just don’t have enough facilities to meet demand.
As always this challenge has led to innovation – new manufacturing methods – single use manufacturing is being pioneered for use with Biosimilars.
We expect or even demand Biosimilars be cheaper – But can we achieve the dramatic reductions seen with small molecule drugs – this is probably unlikely in the short term.
The last challenge is as a patient. We need to be confident that a biosimilar will provide the same effect as the original in the same way we learned to trust the generic small molecule drugs. The next step is interchangeability, yet to be confronted, but will eventually need to be overcome. Therefore although we have already moved forward with Biosimilars we are only at the end of the beginning with these molecules.
Biosimilars push us to understand these drugs much better than we have in the past. Production issues need to be overcome and this is radically changing our industry.
As patients we have the opportunity to access drugs which may in the past have been beyond our means for a variety of conditions.
Let us not forget that biologics are still at an early phase, Biosimilars will provide answers for only a handful of diseases but hundreds of potential new molecules are being developed for other conditions.