Here's an interesting point of view from The Bioprocess Blog where they weigh in on the question of whether or not biosimilars will have any impact on the worldwide need for biological manufacturing capacity. Short version: they conclude they will not have a significant impact.
Will biosimilars really have an impact on capacity?.
I don't really agree with their reasoning. I think when yo ufocus on the current pipeline and use it as a surrogate for what will happen you aren't properly viewing success rates. In the current pipeline you end up with lots of failures from the novel drug candidates. But with biosimilars, you should see much higher success rates in development as the targets are proven.
Secondly, the authors focus on the impact of biosimilars that have hit Europe to date -- mainly molecules like EPO and hgh. I think this neglects all the mAbs that we should be seeing soon and I think those will have a higher impact on manufacturing needs.
Thirdly, the discussion seems to be centered on what is happening (or not) in Europe and the US. The post was ostensibly about "worldwide biological manufacturing" capacity. If so, there should be much more attention paid to what will happen as biosimilars start coming on line in China, India, Korea, etc. I don't think the EU model will be a very good surrogate for what will happen in those local markets when local producers start bringing their drugs to market.
So I respectfully disagree with the authors conclusions. I think the new players in the new economies will have a much bigger impact and represent a much larger opportunity.
Posted by Bruce Lehr July 26th 2011.
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