Merck to bring biosimilar drugs to Canada

By Andrew Rickard | December 04 2015 11:46AM

Merck Canada is preparing to offer a lower cost solution to biologic drugs.

On Dec. 3, Merck announced that it plans to bring biosimilar medicines to Canada in the near future. These drugs, also known as Subsequent Entry Biologics (SEBs), are not exact copies but are similar to the original medical products that are manufactured by a different company. They enter the market after a previously authorized version and are used to treat diseases such as cancer, rheumatoid arthritis, growth deficiencies, Crohn's, diabetes, or psoriasis.

The United States Food and Drug Administration (FDA) says that biosimilars should not be called generic drugs, since they are made from living organisms and are distinct from the original medication. However, the FDA notes that biosimilars “have no clinically meaningful differences in terms of safety, purity, and potency from the reference product”.

Merck suggests that, provided the appropriate reimbursement conditions are in place, biosimilar medicines could significantly lower costs for the Canadian healthcare system. Merck also points out that biologic drugs are one of the fastest-growing segments in pharmaceutical spending. For the 12 months ending August 2014, the use of biologics increased by 12% and sales accounted for $5.6 billion or 24% of the entire Canadian pharmaceutical market.

"I prescribe the medicine that is in the best interest of my patients, given their medical conditions and clinical needs," comments Dr. Edward Keystone, a rheumatologist and director of the Rebecca MacDonald Centre for Arthritis and Autoimmune Disease at Mount Sinai Hospital in Toronto. "The question is whether public and private insurers will give priority to biosimilars. Should they choose not to, physicians will most likely continue to prescribe the originator biologics, being that these medicines are historically what they have been accustomed to, which would then limit the use of biosimilars in the long term and prevent the ability to lower drug costs."

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