Biosimilars Debate Packs The Room At BIO
By Rob Wright, Chief Editor, Life Science Leader
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By Rob Wright
Though it is always hard to boil down a week’s worth of work down to one or two favorites, here are mine for the recent BIO conference. The first was actually a colocated event entitled Diversity, Inclusion, & Life Sciences, which took place on April 21. This event struggled with the same issues as BIO — rich in content and relevant speakers. For example, Dr. Freda Lewis-Hall, chief medical officer from Pfizer, provided a keynote and was active in other discussions including the session in which I served as moderator.
My favorite session at BIO was “Automatic Substitution of Biologics: Who Decides and With What Criteria.” When I saw the title I thought this would be interesting, especially since the CEO of DSM, Xander Wessels, recently asked me if I thought biosimilars would ever be a reality in western markets. What made this session so good? Everything. For starters, Joseph Miletich, SVP Research & Development for Amgen, provided an excellent tutorial on biosimilars that even an 8th-grade science student would have understood — analogizing biosimilars to snowflakes. Miletich ascribes to the notion that any law around biosimilar auto-substitution should have sound policy, place the patient first, and outline the important role the physician would play in monitoring response. Further, he ascribed to government being proactive in adopting policy sooner rather than later. This opinion went counter to those of other panel members Brynna Clark, senior director, State Affairs, Generic Pharmaceutical Association; and Michael Rodrigues, Senator, Massachusetts State Senate who seem all too inclined to be deliberate, which I interpret as S-L-O-W. When I arrived at the session there was one chair left. By the end it was standing room only. I actually felt sorry for moderator, Erika Lietzan, special counsel with Covington and Burling LLP, because she didn’t get to use any of the questions she prepared because the audience was all too willing to engage with the panel during the Q&A. From my point of view, I side with Miletich for sooner rather than later biosimilar substitution law. So does the governor of Virginia who recently signed the nation’s first biosimilar substitution law.