Video: The Evolution of Biotechnology- The Arrival of Biosimilars

December 14, 2015

This short video, produced by Policy Matters Canada, explains some of the differences between biologic medicines and traditional chemical drugs, how biosimilars differ from generics, and how these differences create policy challenges for regulators and lawmakers.

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Video: The Evolution of Biotechnology- The Arrival of Biosimilars

December 14, 2015

This short video, produced by Policy Matters Canada, explains some of the differences between biologic medicines and traditional chemical drugs, how biosimilars differ from generics, and how these differences create policy challenges for regulators and lawmakers.

Read More


ASBM Presents to Ontario Hospital Association

December 9, 2015

On December 9th in Toronto, ON, ASBM Executive Director Michael Reilly gave a presentation entitled “Biosimilars: On the Forefront of Medical Innovation” as part of a webinar hosted by the Ontario Hospital Association (OHA). The OHA is a leader on the issue of patient safety in Canada and represents 151 hospitals. Prior to the presentation, a […]

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Health Canada Releases New SEB/Biosimilar Guidance

December 8, 2015

On December 7th, Health Canada released a revised draft of Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars) for stakeholder consultation. The obective of the Guidance, entitled “Information and Submission Requirements for Subsequent Entry Biologics (SEB Guidance)“, is to provide sponsors with guidance to satisfy the information and regulatory requirements under the Canadian […]

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Health Canada Releases New SEB/Biosimilar Guidance

December 8, 2015

On December 7th, Health Canada released a revised draft of Guidance on Subsequent Entry Biologics (the Canadian equivalent of biosimilars) for stakeholder consultation. The obective of the Guidance, entitled “Information and Submission Requirements for Subsequent Entry Biologics (SEB Guidance)“, is to provide sponsors with guidance to satisfy the information and regulatory requirements under the Canadian […]

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EMA Accepts Application for Second Biosimilar for Enbrel

December 8, 2015

On December 8th, the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) for the second biosimilar to the EU-licensed Enbrel (etanercept), a tumor necrosis factor alpha (TNFα) inhibitor. The biosimilar is seeking approvals for all indications of its reference product, which is used to treat autoimmune conditions such as rheumatoid arthritis and psoriasis. More […]

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ASBM Presents to Canadian Patient Advocates

November 20, 2015

On November 19th, ASBM participated in the Expert Patient Advocates and 21st Century Therapies Forum held in Toronto, Ontario. The forum was sponsored by the Canadian Organization for Rare Disorders (CORD), which works with governments, researchers, clinicians and industry to promote research, diagnosis, treatment and services for all rare disorders in Canada.  ASBM Executive Director Michael Reilly joined a patient […]

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ASBM Presents to Canadian Patient Advocates

November 20, 2015

On November 19th, ASBM participated in the Expert Patient Advocates and 21st Century Therapies Forum held in Toronto, Ontario. The forum was sponsored by the Canadian Organization for Rare Disorders (CORD), which works with governments, researchers, clinicians and industry to promote research, diagnosis, treatment and services for all rare disorders in Canada.  ASBM Executive Director Michael Reilly joined a patient […]

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Governor Christie Signs NJ Biosimilars Bill

November 14, 2015

Governor Chris Christie has signed Assembly Bill 2477 (A2477), which had passed the New Jersey House and Senate unanimously, in May and June respectively. ASBM’s letters of support for A2477 may be read here and here. The Governor’s signature of A2477 brings the total to eighteen states and Puerto Rico which have passed such bills, with 12 […]

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Governor Christie Signs NJ Biosimilars Bill

November 14, 2015

Governor Chris Christie has signed Assembly Bill 2477 (A2477), which had passed the New Jersey House and Senate unanimously, in May and June respectively. ASBM’s letters of support for A2477 may be read here and here. The Governor’s signature of A2477 brings the total to eighteen states and Puerto Rico which have passed such bills, with 12 […]

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