Biosimilars (also referred to as follow-on biologics) are a type of medical products that are a copy of an original product (or at least a drug demonstrated to be highly similar to a biologic drug that was already authorized for sale), manufactured by a different company and have the status as officially approved versions of original products. Such products can be manufactured when the original product’s patent expires. The advantage to consumers, provided that an ope market develops, is that the medicines can be offered to consumers at a lower price.
In some ways the process is like the manufacture of generic drugs. However, for a long time biological products have been excluded from this process due to their complexity and with the risks of something going wrong and causing patient harm. In recent years more research has gone into developing biosimilars and technology transfer has improved considerably (for example, as outlined by the author Trevor Deek’s in the book “Phase Appropriate GMP for Biological Processes: Pre-clinical to Commercial Production”).
In the U.S., as an example, the path towards biologics becoming biosimilars was made possible when President Obama signed the Patient Protection and Affordable Care Act (Affordable Care Act) in 2010. However, progress has been relatively slow. A major reason for the traction is due to patent litigations dragging out biosimilar launch dates.
Faster progress may now be possible in Canada following British Columbia’s decision to expand the sustainability of its PharmaCare program to include the use of biosimilars. The aim is to create create opportunities for new drug listings and boost existing coverage for patients. One of the first medications to be included in the program is Jardiance, which is a diabetes drug, plus the psoriatic arthritis drug Taltz.
According to Adrian Dix, Minister of Health: “B.C. is leading the country by promoting the widespread use of biosimilars, which have been proven to work just as safely and effectively as higher priced biologics. To date, Canada is far behind European jurisdictions. Biosimilars are a necessary step to ensure PharmaCare provides existing coverage for more people and funds new drugs well into the future.”
The news has, perhaps unsurprisingly, been welcomed by Biosimilars Canada, a national association representing Canada’s biosimilar medicines industry. Here Michel Robidoux, Chair of Biosimilars Canada and President and General Manager of Sandoz Canada states: “Biosimilar medicines have an important role in supporting health care sustainability and patient care, and Biosimilars Canada congratulates the Government of British Columbia for its Canadian and North American leadership in promoting and expanding the use of biosimilar medicines.”
While the Canadian advance is noteworthy, and arguably places the country ahead of the U.S., Europe continues to maintain momentum in the biosimilars space. Since 2005, the biosimilar regulatory framework has existed in Europe via the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA). By the end of 2018, 48 biosimilar applications have been approved within the European Union.
