Safe Biologics

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.

https://www.youtube.com/watch?v=J2jQpSRX0F0

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.

https://www.youtube.com/watch?v=J2jQpSRX0F0

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.

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 Food and Drugs Act and Regulations for the authorization of SEBs in Canada.

The Guidance Document and information on submitting feedback may be found here. Comments will be accepted until February 15th. 

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 Food and Drugs Act and Regulations for the authorization of SEBs in Canada.

The Guidance Document and information on submitting feedback may be found here. Comments will be accepted until February 15th. 

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 information can be found here. The EMA Committee for Medicinal Products had recommended approval for the first biosimilar to Enbrel, Benepali, on November 20th.

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 advocate, researchers and representatives from the biologic and pharmaceutical industry in a panel discussion on “Innovation in Medicines”. The panel was chaired by Mark Lundie, Director, Medical Affairs, Rare Diseases, Pfizer Canada Inc., Toronto.  Innovations discussed included new biologic and biosimilar therapies, the repurposing of old therapies, targeted drug discovery, and adaptive clinical trials.  Prior to the discussion, Mr. Reilly gave a 15-minute presentation on the benefits of biosimilars, highlighting policy challenges which regulators must address to safely bring these to patients. Mr. Reilly’s presentation may be viewed here.