I’ve just returned from the big BIO bash, where I was honored to moderate the panel discussion, "Lessons From In-Licensing Partnership: Biotech Company Partners with Global Pharma to Deliver Cutting-Edge Follow-On Biologics.” I was joined on the podium by joined by Arun Chandavarkar, Chief Operating Officer of Biocon Ltd.; Stephen Hoge, Principal at McKinsey & Co.; and Diem Nguyen, General Manager, Biosimilars, Pfizer.
Here’s how I opened the discussion:
Woody Allen said that, “Change should always be expected – except from vending machines.” But management guru W. Edwards Deming hits closer to the mark, “Change is not required. Survival is not mandatory.”
Many believe that the age of the blockbuster is over. Cost concerns are more challenging than ever. And we are struggling with what “personalized medicine” really means.
We are now in the era of post-patent medicine where advances in manufacturing, incremental innovation, and molecular diagnostics are as important as new molecular entities, and safety is as important (and as improvable) as efficacy.
The era of post-patent medicine is also the epoch of biosimilars. But will biosimilars really be as important an element of change as many believe. Will it be a game changer?
I believe the answer is “yes,” but I am not sure whether or not all the changes will positively affect the advancement of the public health. I fear the expectations that biosimilars will radically reduce costs are overstated. I fear that safety concerns are being understated and that the risks to innovation are real.
As Eli Lilly & Co. CEO John Leichleiter said, "Creating and maintaining the conditions for innovation to flourish is challenging and complicated work - work that is never finished.”
Case in point -- there seems to be general consensus that, with a clear FDA pathway still off in the future, BLAs are the way to go. Hence a redefinition of BLA as “Beat Legislative Ambiguity.” No aBLA biosimilar.
EMA and FDA recently announced that they are setting up a "cluster" on biosimilars to increase communications between the two agencies on the topic and the two agencies will discuss harmonization of regulatory requirements. Yet fundamental differences in the laws they administer make harmonization difficult.
Beyond a standardized regulatory pathway, there are many issues on the table:
* The role of “next generation biologics” (or, if you prefer, “biobetters”)
* Bioequivalence, interchangability, and therapeutic substitution
* The debate over distinguishable names and robust post-marketing surveillance
* GMP standards
* Reference products and clinical trial requirements and design
* And, last but not least, Patent Life vs. Data Exclusivity
And that’s not even considering PDUFA V. Nobody said it was going to be easy.
This morning’s panel won’t answer every question – and it is very likely to raise a few more. Our hope is that the panel will provide useful and timely insight on how global pharma and biotech companies can collaborate to develop, gain authorization, and globally commercialize cutting-edge follow-on biologics.
(And I believe we succeeded in delivering a thoughtful and thought-provoking discussion.)
