The introduction of biosimilars will increase access to safe, effective and affordable biologics, while stimulating fresh innovation in a field that has to date been short of sufficient competition. 

The new US biosimilars pathway appropriately applies consistent and rigorous scientific criteria, respects intellectual property rights, and creates fair exclusivity for innovators.  Sandoz and Novartis have confidence in the FDA's expertise and experience with biologics and look forward to working with the Agency as it implements the new pathway.

The passage of biosimilar legislation is a historic moment comparable in many ways to the US Hatch Waxman Act of 1985, which effectively paved the way for the modern generics industry.  As with Hatch-Waxman for generics, however, the passage of legislation will be only the beginning of bringing biosimilars to market in the US.

Going forward, two crucial issues will be:
1) How the pathway is actually implemented: for instance, the implications of being required to hand over the full application dossier to the reference product manufacturer, as well as the extent to which the FDA is provided with the necessary resources to achieve its goals
2) How the pathway is supported at the market level: in particular, the extent to which market based incentives are established as they have been for generic versions of small molecules, to encourage payors and physicians to use and prescribe biosimilars. Appropriate incentives to include biosimilars on formularies and to prescribe these medicines are needed to ensure that the substantial potential savings offered by biosimilars are actually passed on to US patients, physicians and payors.

Sandoz is the pioneer of biosimilars and - as the only company with three marketed biosimilars and nearly USD 120 million in 2009 sales - the world leader in developing, manufacturing and commercializing these essential new medicines, which promise to dramatically broaden access for patients worldwide.  Biologics have already revolutionized modern medicine and will continue to do so, but patient access is increasingly limited by high costs and growing demand.