Sonia T. Oskouei, PharmD: Biosimilars and Innovation

Transcript

So biosimilars really have had a significant impact at innovation in general, including oncology. And so here's my perspective: I think it not only represents innovation but it also fosters innovation.

So biosimilars, the regulatory pathway, the Biologics Price Competition and Innovation Act, innovation’s in the name, was really innovative to create an expedited pathway to bring these life-saving biologic therapies to market sooner. So not only was the regulatory pathway innovative with creating the concept of extrapolation and relying on the totality of evidence to be able to do so, but also the manufacturing process for these biosimilars represent innovation.

The technology and the ability to develop these biologics have come a long way even since the originator biologics were First developed. Now the way that biosimilars have fostered innovation and continue to do so, we could see it even from the originator biologics, we could see enhanced formulations or even dosage form. So, biologics that were traditionally infused are now available [subcutaneously] to other areas that we see it fostering innovation is even in the health system setting.

Creating these biosimilar strategies and processes from a health system perspective has really catapulted the development of a true education program within health systems to ease the transition to a biosimilar or start a new biosimilar for a new patient. A lot of time that's that goes with educating nurses, physicians, pharmacists, really a multi-stakeholder approach, and really keeping the pressure patient at the forefront of it.

Being able to create the process where patients are notified, educated on what these products are, why it's okay to be switching, and the potential impact it could have on out-of-pocket costs and the finance is really important, and that's represented innovation from a process standpoint within health systems too.