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Toronto, ON – Apobiologix®, a Division of Apotex Inc., today launched Grastofil®, its first subsequent entry biologic (SEB) approved in Canada. SEBs are referred to as biosimilars in some other markets. Grastofil® is a biosimilar of Neupogen®. The approval of Grastofil® represents a significant advancement toward healthcare savings for all public and private payers. Grastofil® is used to treat neutropenia, a lack of certain white blood cells caused by cancer, bone marrow transplant, receiving chemotherapy or by other conditions. This market is currently worth over $130 million.
The present drug spend on biologic medicines in Canada is valued at $4.6 billion. In less than a decade, spending on biologics has increased by more than 200%. While biologics represented only 1% of claims in 2015, they accounted for nearly 21% of total prescription drug spending. "The successful introduction of biosimilars represents an opportunity for the sustainability of our healthcare system by increasing competition, reducing costs and allocating savings to help fund other much-needed therapies. Grastofil® is Apobiologix'® first step in helping achieve this," stated Steve Lydeamore, Apobiologix President.
Canadian regulators were early adopters in identifying the need for a regulatory framework for approval of SEBs and released clear guidelines in March 2010. Health Canada has been supportive of Apobiologix'® efforts as we progress our development program and submit applications to the Biologics and Genetic Therapies Directorate (BGTD).
The Apobiologix® launch of Grastofil® is a natural extension of Apotex's 42 year history in Canada providing quality, affordable medicines. Founded in 1974, Apotex has grown to over 5,000 employees in Canada and 8,000 globally with exports to 115 countries. Apotex is the largest R & D company in the Canadian pharmaceutical industry including investments of $330M in the development of biosimilars to date with significant further expenditures planned.
Neupogen® is a registered trademark owned by Amgen Inc.
Global Director, Corporate Communications