Biosimilars
| By Mahdis Dorkalam
Regulatory Approval of Biosimilars in Canada
T
he evolution and creation of innovative technologies, medications, and transformation of patient care continue to push forward at an astonishing pace. With the advancement of medicine over the years, we have seen how biologic drugs and treatments have transformed patient care. Biologics are therapies derived from living cells, as opposed to traditional drug products which are mainly comprised of synthesized chemicals. Today, physicians use biologics in effectively treating common disorders such as diabetes, multiple sclerosis, various forms of cancer and several other diseases. Despite their effectiveness, biologics have two key drawbacks to their use, and that is their high cost, coupled with limited accessibility through provincial and territorial formularies for most patients. With the aging Canadian population, increased life span, prolonged need for continued health care and the need for more complex and expensive treatments, the increased health care costs are inevitable. 10 BIOTECHNOLOGY FOCUS August/September 2018
Although Health Canada provides approval of new medications at a federal level, the reimbursement by public insurers is governed at the provincial level. This additional level of approval adds further complexity to the use of potential life saving, yet costly therapies. Hence, geographical location of a patient across our nation can have a huge bearing on availability and access to treatments. The large cost associated with biologics is due to the intricacies related to the development of biologics. As many widely used biologic therapies are reaching patent expiry – resulting in loss of exclusivity, along with the constant need for cost saving alternatives – development of biosimilars is on a rapid rise. A biosimilar must show high similarity to a biologic drug that has already been authorized for sale (known as the reference biologic drug (RBD)) by Health Canada. Biosimilars are approved based on a thorough comparison to a reference drug and may only enter the Canadian market after the expiry of the reference drug patents for each indication
being sought and resolution of data protection issues.1,2 The slow growth of the biosimilar market in Canada is due to several issues, such as lack of clear and transparent regulatory requirements, patient preferences, reluctance of physicians and health care providers and pharmacists to readily prescribe and substitute biosimilars. The difficulties being faced in developing a naming convention specific to biosimilars and the slow uptake by the provincial governments and insurers further adds to the complexity of this market. The European Union (EU) presently dominate the market with numerous biologics in use, owing to the favourable government regulations in this region. Meanwhile, in Canada and the United States (US), Health Canada and the Food and Drug Administration (FDA) respectively have been less flexible in the approval of biosimilars. In Canada, biosimilars are regulated as new drugs under the Food and Drugs Act and the Food and Drug Regulations. Health Canada’s
