Publication
UK Carbon Border Adjustment Mechanism: how will it work?
In February, we reported on the Department of Energy Security and Net Zero’s confirmation that a UK Carbon Border Adjustment Mechanism (CBAM) would be bought into force by 2027
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Global | Publication | December 2016
Fact sheet: Fact Sheet: Biosimilars [Fact Sheet]
Date: Revised December 7, 2016
Related enactments: Food and Drugs Act, RSC 1985, c F-27 | Food and Drug Regulations, CRC, c 870 [Food and Drug Regulations]
Health Canada has revised its fact sheet on biosimilar biologic drugs (biosimilars), which were formerly known as subsequent-entry biologics. This update follows Health Canada’s recent revisions to the Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs (the Guidance Document).
In line with recent changes to the Guidance Document, the Fact Sheet has been substantially rewritten and contains an overview and description of the regulatory framework for biosimilars. The Fact Sheet also includes a new section on drug and patient access, which includes the following:
Health Canada’s authorization of a biosimilar is independent of provincial, territorial, or private drug plan decisions regarding its formulary listing and reimbursement.
Health Canada’s authorization of a biosimilar is not a declaration of equivalence between the biosimilar and its reference biologic drug, and is independent of any decision as to interchangeability between these drugs. Interchangeability decisions are a matter of provincial and territorial jurisdiction.
Health Canada recommends that decisions regarding switching to a biosimilar from its reference biologic drug should be made by treating physicians in consultation with the patient.
For more information on Health Canada’s revised approach to the regulation of biosimilars, see our report on the full Guidance Document here.
Fact Sheet: Fact Sheet: Biosimilars
Guidance Document: Information and Submission Requirements for Biosimilar Biologic Drugs (November 14, 2016)
Previous documents: Guidance For Sponsors: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) (March 5, 2010)
Draft - Revised Guidance Document: Information and Submission Requirements for Subsequent Entry Biologics (SEBs) (December 7, 2015)
Related enactments: Food and Drugs Act, RSC 1985, c F-27
Publication
In February, we reported on the Department of Energy Security and Net Zero’s confirmation that a UK Carbon Border Adjustment Mechanism (CBAM) would be bought into force by 2027
Publication
International financial markets have started to show significant interest in nature and biodiversity. Whilst climate change and greenhouse gas emissions have made the headlines in recent years, there has been much less focus on their equally important counterparts, nature and biodiversity. However, that has started to change.
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