The Biosimilar Landscape In Canada

Biologics are drugs which contain an active medicinal ingredient that is derived from living organisms or their cells. They are generally larger and more complex than chemically produced small molecule pharmaceuticals. Biosimilars are approved by the short-cut of showing to regulators they are sufficiently similar to a biologic reference drug that is already approved for sale. Biosimilars may enter the market after showing expiry, invalidity or non-infringement of the reference drug patents. The biosimilar manufacturer may also have to wait out a data exclusivity period. The patent litigation may be through conventional patent infringement litigation or through the specialized Patented Medicines Notice of Compliance Regulations (PMNOC) that allow patentees to try to block biosimilar products from receiving their marketing authorization.

Monoclonal Antibodies

Monoclonal antibodies are a class of biologics used to treat autoimmune diseases, inflammation and cancers. A number of monoclonal antibody biologic reference drugs, and biosimilars, have been approved for marketing in Canada. There has been much litigation over the entry of certain biosimilars into the Canadian marketplace.

Litigation involving approved biosimilars

Infliximab

Infiximab is a biologic drug used in the treatment of autoimmune diseases including Crohn's disease and psoriasis, as well as inflammation caused by ulcerative colitis and arthritis. Janssen's Remicade was the first infliximab drug approved for marketing in Canada in 2001. Remicade was the reference drug for the development and subsequent approval of three infliximab biosimilars: Remsima (Celltrion), Inflectra (Hospira/Pfizer) and Renflexis (Samsung Bioepis/Merck).

Inflectra and Remicade were the subject of a recent impeachment/infringement patent proceeding.1 Hospira challenged that the Remicade patent2 was invalid. Janssen/Kennedy Trust counterclaimed that Hospira's biosimilar, Inflectra, infringed the patent. The Federal Court determined that the patent was valid3 and infringed. 4 The Court further found that, in addition to direct infringement, Hospira induced infringement of the Remicade patent because its product monograph for Inflectra amounted to instructions for infringement. 5 Pending Hospira's right to appeal, this decision closes the door to future sales of that version of Inflectra in Canada until expiry of the Remicade patent.

Adalimumab

Adalimumab is a monoclonal antibody used to treat arthritis and autoimmune diseases. Abbvie Corp's Humira was the first adalimumab biologic approved for marketing in Canada and...