Search results for subsequent entry biologics (SEBs)

Are the perspectives regarding the use of biosimilars in the setting of haematology and blood and marrow transplant changing?

Introduction: Canada is among the leading spenders in pharmaceuticals. Based on projected figures, the cost of pharmaceuticals is expected to rise by another 6–12% by 2023. Approximately CAN$4.6 billion of healthcare funding is spent on biological drugs (including growth factors and monoclonal antibodies) which are commonly used in the setting of haematology and blood and […]

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Current state of subsequent entry biologics (biosimilars) in Canada: a view from regulatory, reimbursement, clinician, and patient perspectives

Abstract: Biological molecules represent a significant portion of therapies utilized in Canada. Biosimilars, also known as subsequent entry biologics (SEBs) in Canada, are highly comparable versions of the originator products. Over the next few years, a number of patents for innovator biologicals will expire in Canada and this creates a tremendous opportunity for the entrance […]

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Biosimilars patent litigation in Canada and Japan: a comparative strategic overview and EU and US update

Abstract: Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed ‘interchangeable’ by medicines regulatory bodies, such as the US Food and Drug Administration. Biosimilar patent litigation continues to evolve as biosimilars enter new global markets. This manuscript is the second part of a manuscript that took a look […]

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Subsequent entry biologics (biosimilars) in Canada: approaches to interchangeability and the extrapolation of indications and uses

Abstract: The principles Health Canada use when extrapolating the indications and uses of a biosimilar product subsequent to a single clinical trial or limited number and scope of clinical trials during product development are discussed. The principles underlying the regulatory framework for subsequent entry biologics (SEBs or biosimilars) in Canada explain the position taken by […]

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