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08/29/2012

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Shrivathsa

Feel the 'Aha' comment of Tom is becoming much more reality. As Ron said, price becomes the key for commercial success of biosimilars. Also, the number of competitors have grown hence early bird gets the chunk of pie, possibly exclusivity. Moreover, for interchangeability you need very less differences between biosimilar and innovator to build the confidence of regulator. Hence the development path has to be as short and optimum as possible. With highly innovative and incisive development at early stage (before Ph1) and showing absolute similarity can get concessions from regulators (like FDA) for shorter development time, hence faster to market and can be a winning formula!

BioDueDiligence

I think you're right that there will be a barbell pattern here. Either invest as little as possible in the process development and get to market first, or take the approach that Momenta Pharma MNTA is, invest heavily in characterization and process development in order to so precisely copy the reference drug that they can achieve interchangeable status

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