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Generics outfit Sandoz has achieved another milestone with the approval of Omnitrope in Canada. On April 20th 2009, Health Canada granted a Notice of Compliance for Omnitrope, making it the first Subsequent Entry Biologic (SEB) to be approved for sale in Canada. For those unfamiliar with the lingo, SEB is the regulatory term used by Health Canada equivalent to "Biosimilars" in Europe or "Follow on Biologics" in the USA.

Omnitrope, a somatropin (rDNA origin) for injection, is approved for the long-term treatment of children with growth failure due to an inadequate secretion of endogenous growth hormone, and long-term replacement therapy in adults with growth hormone deficiency due to an underlying hypothalamic or pituitary disease or who were growth deficient during childhood. With this authorization, Omnitrope carries the reputation of becoming the first biogeneric product to be approved in Europe, USA & Canada. The market authorization was based on quality, non-clinical, and clinical information submitted. Details about the studies found here.

Whilst the debate over cost savings versus quality continues to intensify between regulatory bodies and law makers, it is encouraging to see products trickling through a system whose effectiveness cannot be evaluated unless it is put into practice. , the current system (however skeletal it may be) needs to be tested in order to:
1)Define the parameters of substitution of biosimilars for innovator products;

2)Determine the extent of pre-clinical studies & clinical trials required to demonstrate safety and comparability;

3)See whether true copies of biologics can be made despite the original products being covered by extensive trade secrets, patents and proprietary technologies;

4) Test the financial sustainability of biogeneric manufacturers. The development of each biogeneric product will be a lengthy, complex process, and is projected to cost about $200 million, compared to approximately $30 million for a traditional generic drug;

5) Quantify the extent of cost savings and the impact of competition on cost reduction;

6) Gauge consumer confidence and acceptance.

It is clear that regulations for biosimilars or follow-on biologics will be implemented in the near future. However, What remains to be seen is whether political pressure from influential groups and an extremely cautious approach on the part of the legislators can be balanced out to develop a functional pathway to approval.