The United States Food and Drug Administration (FDA) released
Draft Guidance on February 9, 2012 for obtaining approval of
subsequent-entry versions of biologic drugs (also known as
biosimilars). Biologics are substances derived from living
organisms such as antibodies, blood products, nucleic acids, and
enzymes. Biologics are often much larger and more complex than
conventional chemically-synthesized small molecule pharmaceuticals.
This makes the comparison of biosimilars to their approved
counterparts difficult. Comparative clinical trials are often
required. This is a much higher standard than for conventional
generic pharmaceuticals which are approved upon showing
bioequivalence (no clinical trials).
A new approval pathway for biosimilars in the U.S. was
introduced in March 2010 in the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act). This is the first detailed
FDA interpretation of the BCPI Act. The Draft Guidance is presented
as a series of Questions and Answers and includes information on
the evidence required to demonstrate biosimilarity or
interchangeability with an approved reference product as well as
technical details on the approval process.
A 60-day comment period on the Draft Guidance is now open until
April 9, 2012. The Draft Guidance will provide valuable information
to drug manufacturers interested in developing biosimilar versions
of FDA-approved biologics.
Effective September 1, 2016, the Disposition of Surplus Real Property Regulation to the Ontario Education Act was amended with the intention to reduce barriers to the formation of health and community hubs in Ontario.
This appeal relates to two generic drug submissions for two different products: exemestane and infliximab. Both submissions cross-referenced the submission of another generic company that had received a Notice of Compliance.
Two recent decisions from the Supreme Court of Canada directly affect Quebec's farm businesses by confirming La Financière Agricole du Québec's discretion in the administration of the farm income stabilization program...
On October 6, 2016, the Ontario Legislature reintroduced the Patients First Act, 2016 as Bill 41. Bill 41 is very similar to its predecessor, Bill 210, which was introduced in June 2016, but makes some important changes to the previous bill.
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