First Subsequent Entry Biologic Approved in Canada

    CGPA welcomes competition to Canadian market for biologic medicines

    TORONTO, April 23 /CNW/ - The Canadian Generic Pharmaceutical Association
(CGPA) today welcomed the first ever approval of a subsequent entry biologic
(SEB) in Canada and urged Health Canada to move forward with the completion of
its SEB guidance without further delay.
    On April 20, 2009, Health Canada approved Sandoz's Omnitrope(TM), the
first version of a previously approved recombinant biologic drug to be
approved by Health Canada under the regulatory term SEB. It is a recombinant
human growth hormone used for the treatment of children with growth failure
due to growth hormone deficiency (GHD) and for the treatment of adults with
either adult onset or childhood onset GHD. The product received market
authorization in both the European Union and United States in 2006.
    "This approval demonstrates that generic companies can develop safe and
effective biologic medicines, and clearly demonstrates that a sound scientific
and legal environment already exists in Canada to support the approval of
subsequent entry biologics," said CGPA President Jim Keon.
    In Canada, a number of these biologics will be coming off-patent over the
next five years, and the patents for others have already expired. Many of
these drugs cost more than $10,000 per patient each year - expenditures that
many consumers, businesses, insurers and private and public health care
providers find unacceptable and unaffordable.
    "Competition from safe and effective subsequent entry biologics will save
consumers, provincial drug plans and private insurers millions of dollars each
year and provide many more patients with access to lifesaving treatments,"
Keon said.
    In Canada, the existing legislative and regulatory framework for
pharmaceuticals and biologics serves as the legal basis for approval of
subsequent entry biologics. Health Canada is currently working to provide
greater clarity to its submission and approval requirements through the
development of a guidance document. Consultations on the second draft of this
guidance document will conclude at the end of May 2009.
    "Canadian generic pharmaceutical companies have already successfully
developed and registered generic biologics in other jurisdictions, clearly
demonstrating their scientific, medical and technological capabilities," said
Keon. "We urge Health Canada to move forward with the completion of its SEB
guidance document without further delays in order to bring additional clarity
of the requirements for sponsors of these products and ensure patient access
to these cost-saving medicines as soon as possible."

    About the Canadian Generic Pharmaceutical Association

    The Canadian Generic Pharmaceutical Association (CGPA) represents
Canada's generic drug industry - a dynamic group of companies that specialize
in the production of high quality, affordable generic drugs and fine chemicals
and in conducting the clinical trials required for government approval of
generic drugs. The industry plays an important role in controlling health-care
costs in Canada. Generic drugs are dispensed to fill 52 per cent of all
prescriptions but account for only 23 per cent of the more than $20-billion
Canadians spend annually on prescription medicines.

For further information:

For further information: Jeff Connell, Director of Public Affairs,
Canadian Generic Pharmaceutical Association (CGPA), Tel: (416) 223-2333,
Mobile: (647) 274-3379, Email:, Website:

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