Biosimilars is one of those issues that can make my eyes gloss over, however this panel provided a good overview regarding where we've been and where we're going. And, where we're going is on the immediate horizon - the current Health Insurance Legislation includes provisions that would govern Biosimilars. We could have legislation regarding Biosimilars by the end of the year, assuming a political resolution. On this point one panelists noted that Biosimilars is a "policy" debate within a "political" debate on access and affordable health care.
Some salient points by presenters included:
1.The key issues are: exclusivity,similarity and economics.
2.The stakes are high - by 2016 there will be at least $40B in marketed products coming off patent.
3.The debate on Biosimilars will not be like the brands vs generic debate of past years - it will be a discussion of brands vs brands.
4.Innovation needs to be recognized - the average cost to develop a biologic is $1.2B and the average time to bring a Biologic to market is 10 -15 years.
5.Patent protection is essential and the issues of identical vs similar need to be resolved.
The policy debate on Capital hill represents the convergence of complicated science (Biosimilars)colliding with the most complex legislation governing the industry - Hatch-Waxman Act.
One final comment on exclusivity - one presenter said that when Mick Jagger wrote "I can't get no satisfaction" he received years of exclusivity and financial reward based upon his innovation. Scientists should be afforded the same reward. A somewhat tongue in check comment but relevant.
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