Policy Positions

CANADA

BIOTECanada, Canada's national biotechnology industry organization is working with its stakeholders and the federal government to ensure SEBs are addressed through proper legislative means. For the industry policy position on SEBs as well as further background and recommendations for the regulation of SEBs, click here or download BIOTECanada's Issue Brief.

Gowlings is an active voice with BIOTECanada and its member companies on this issue, participating in the industry committee and providing regulatory expertise via seminars, papers and presentation.

UNITED STATES

In the U.S., the Biotechnology Industry Organization (BIO) has posted its industry principals on "follow-on biologics" as well as a series of fact sheets, including:

• BIO Principles on Follow-On Biologics
• Why is Patient Safety A Concern in the Biosimilars Debate?
• What Legal Issues are Presented by Biosimilars?
• What Arguments Were Made in Genentech's Citizen Petition on Biosimilars?
• How has Europe Approached Biosimilars?
• How do Drugs and Biologics Differ?

Click here to read their fact sheets

EUROPE

EuropaBio, The European Association for Bioindustries provides an overview of biosimilars, recent European legislation, EU Commission Documents and other related press releases, comments and Qs & As. Click here for more.