The patents of a number of biologic medications have already expired or will expire in the near future; and other manufacturers have been able to develop biosimilars; their own versions of the original product. Biologic reference drugs and biosimilars, their cost, and the ever-increasing role both play in the Canadian healthcare system have been a hot topic in the mainstream media in recent months. It seems we’re all curious about the role they will play in the future of treatment for many diseases.
Biologics have offered highly effective new treatment options in a wide range of complex and often devastating diseases like cancer, multiple sclerosis, and inflammation-related diseases. We have seen them help many patients regain a quality of life that would have been unthinkable before.
Biologics require a highly complex manufacturing process that involves living organisms; in contrast to small molecule medications which are produced through chemical reactions between ingredients. The use of living organisms for medical purposes is of course not new – after all, vaccinations and insulin have been part of Western medicine for a long time. What has been revolutionary is the manipulation of these organisms’ genetics to produce biologic medications able to disrupt specific molecules that are key in a specific disease process.
Similar but not the Same
These manufacturing processes are proprietary for each company. Thus, as the name implies, a biosimilar and its reference biologic drug can be shown to be similar, but it will not be considered identical. (By contrast, a generic products contain the same medical ingredients as its reference product.)
Also, biosimilars have to be approved by Health Canada through the same process as a new drug. They must demonstrate not only structural similarity to the reference product, but similar therapeutic effect. The difference lies in the specific data required for a biosimilar submission – for example, clinical trials can be fewer and smaller than those for the reference drug, since the risk of failure is considered much lower. Clinical studies do not need to be repeated for each indication.
Biosimilars help increase the range of options available for prescribing physicians. Given that a biosimilar is neither identical to the original biologic nor to other biosimilars of the same biologic, it is important that each biosimilar is given its own distinct name, so that they can be individually identified and tracked in medical records.
Should ‘Similar’ mean ‘Interchangeable’?
Since biosimilars are not identical to the original product, biosimilars should not be deemed interchangeable with the original biologic medicines. While some regulators and payers are still debating the issue of interchangeability of biologics and biosimilars, Health Canada has stated that the authorization of a biosimilar is not a declaration of equivalence to the reference biologic drug – details can be found on the Health Canada Website biosimilars fact sheet .
Biologics and biosimilars both will continue to play important roles in the constantly evolving treatment landscape. The conversation around interchangeability will continue to evolve, and it will be key to offer healthcare professionals opportunities to join the conversation, to remain up to date, to connect, to reflect and to develop best practices to ensure they are considering all options for their patients.