First Canadian biosimilar approved, amid mixed pharma industry reaction

Health Canada's approval of Sandoz' Omnitrope (somatropin), the first version of a previously-approved recombinant biologic drug to be  cleared by the agency under the regulatory term Subsequent Entry  Biologic has received different reactions from the generics and  research-based pharmaceutical industry. The product received market  authorization in both the European Union and USA in 2006 and, more  recently, gained "biosimilar" status in the EU (Marketletter September  8, 2008).

"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 Canadian Generic  Pharmaceutical Association president Jim Keon. "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," Mr  Keon added.

Patient safety a priority, says R&D