Goodwin (JD Supra Canada)
6 results for Goodwin (JD Supra Canada)
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Quebec Government Announces Shift to Biosimilar Drugs
On May 18th, Christian Dubé, the Minister of Health and Social Services for Quebec announced that the government will begin a shift in favor of the use of biosimilar drugs. The announcement stated that similar to other Canadian jurisdictions, Quebec will eventually cover, with exceptions, only biosimilar drugs on the drug lists.
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Biosimilars Switching Policies in Canada
Further to our post last week on British Columbia’s policy requiring “switching” patients taking Humira, the Alberta government has also implemented a policy, effective May 1, 2021, of requiring that patients over the age of 18 taking Humira switch to one of five adalimumab biosimilars approved by Health Canada: Amgevita, Hadlima, Hulio, Hyrimoz, and Idacio. These patients have until May 1, 2022,
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Amgen Canada Launches Adalimumab Biosimilar
On May 4, 2021, Amgen Canada announced the launch of their adalimumab biosimilar AMGEVITA (reference drug HUMIRA) for the treatment of 11 chronic inflammatory conditions. AMGEVITA is available as a prefilled syringe and a prefilled pen (SureClick® autoinjector) with a range of pack sizes to support dosing according to the approved dosage recommendations in each indication.
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Health Canada approves Merck’s etanercept biosimilar for new indications
On September 15, 2020, Merck Canada Inc., an affiliate of Merck & Co., Inc., announced that Health Canada approved BRENZYS® (etanercept) for the following additional indications...
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Health Canada Drops Suffix in Biologic and Biosimilar Naming Convention
Last week, Health Canada announced that biologic drugs, including biosimilars, will be identified “by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix. Both the brand name and non-proprietary name should be used throughout the medication use process so that biologics that share the same non-proprietary name can be distinguished by their...
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Guidance on Biosimilar Submission Requirements in Canada
Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada recently released a revised Guidance Document on Information and Submission Requirements for Biosimilar Drugs (“Guidance”). The Biologics and Genetic Therapies Directorate (BGTD) within the Health Products and Food Branch of Health Canada is the regulator of biologics...