By Anna Rose Welch, Editor, Biosimilar Development
There are a number of aspects of the U.S. biosimilar industry I find concerning, including slow uptake, innovator fear mongering, and the current lack of payer support. And, though it has been less commonly discussed as of late, I’m also finding myself concerned about the slight identity crisis I feel still exists at the heart of the biosimilar industry. Ultimately, this “crisis” (I use the term loosely) boils down to a few key questions: can we consider biosimilars an “innovation” or an “innovative therapy,” and in what ways do biosimilars contribute to or impact innovation?
One place I’ve seen this topic addressed is in the editorial sphere, where there has been a general rebellion against using the terms “copy-cat” and “knock-off” to describe biosimilars. This is a move I appreciate, because these terms arguably cheapen the complexity of the biosimilar development process. I also wrote an article during the early days of Biosimilar Development, discussing how biosimilars fit into two different definitions of “innovation.”
But I’d say there has not been much discussion about how biosimilars contribute to or will impact innovation — outside of helping the healthcare system afford costly novel therapies. I found my interest in this question sparked upon reading a recent headline in STAT — “Biosimilars: The Cure for Sky-High Drug Prices Or A Stake In The Heart Of Innovation?” The author of this article poses a couple of scenarios about the impact of the biosimilar market. But my main interest was the scenario in which biosimilar competition challenges innovator revenues, and, in turn, dissuades them from pursuing future innovation.
At this time in the U.S., when biosimilars’ reputations are fragile due to inexperience and fear mongering, I’d hate to see biosimilars implicated in a future dearth of drug R&D and innovation. While biosimilars could certainly challenge innovators’ revenues and, in turn, future R&D, I daresay this will not be a wide spread evolution.
After all, we’ve been in a similar place before. The rise of the small molecule generics industry certainly posed a great challenge for innovators. Yet, somehow, companies continued to innovate in the small molecule space. In fact, though small molecule generics accounted for upwards of 90 percent of prescriptions dispensed in 2016, rheumatologists were eagerly awaiting Pfizer’s recently approved small molecule Xeljanz as a much needed alternative to biologics.
Outside of the small molecule market, we also saw the growth of the now-vibrant biologics market. And here we are today, on a site called Biosimilar Development, a type of drug that was considered impossible to make a meager number of years ago. We also recently celebrated the FDA’s approvals of the first gene therapies (multiple gene therapies) last year.
How Biosimilars Have Contributed To Innovation
This is all to say, regardless of the intimidating amount of market competition generics have posed for innovators, the pharmaceutical industry has continued to evolve and explore new and gutsy avenues for product development — in both small and large molecule fields. But I also think there have been a number of advances within the biosimilar industry that could be important tools for driving or contributing to future innovation.
The emphasis on analytics in biosimilar development has been challenging for a number of stakeholders. For those trained in biologics development, with its heavy reliance on clinical trials, biosimilars have shaken things up significantly. Not only have they required the development of a new regulatory pathway, completely different from that of generics, but the scientific concepts of extrapolation (in the case of Canada, at first) and interchangeability in the U.S. introduced new data needs and clinical trial strategies. Similarly, from what I heard at the DIA Biosimilars conference this past October, there is still plenty of room to grow in terms of advancing clinical work for biosimilars. As one expert discussed, there are several innovative strategies companies could employ to better address residual uncertainty and, in turn, curb the size of Phase 3 clinical trials.
In fact, speaking of clinical innovation, in a nice blending of both biosimilar and innovator worlds, we recently saw Novartis launch the superiority trials EXCEED and SURPASS for Cosentyx —of which, SURPASS pits Cosentyx up against Sandoz’s adalimumab biosimilar (currently under review by the FDA). This strategy not only furthers the data and knowledge about an important innovator in the space, but it also instills greater confidence in the biosimilar itself, helping Novartis generate more in-demand in-patient data prior to a market launch.
Finally, at the recent CBI Biosimilars Summit, a presentation addressed the possibility that a biosimilar mAb, for instance rituximab, could be attached to CAR-T technology. Not only could attaching a biosimilar instead of the innovator render CAR-T therapies cheaper, but this also serves as an alluring outlet for biosimilar makers to differentiate their products and, perhaps, bolster a mAb’s efficacy.
It goes without saying that I cannot know for sure the impact biosimilars will have on their competitors or their future R&D goals at this point in time. (If that were the case, I’d be immensely popular at biosimilar conferences, where there are currently more questions than answers.) But when faced with the question of whether they could actually stall the progress of innovation, my impulse is to say absolutely not. I would like to believe the work being done in the biosimilar space today will not be influential for the biosimilar market alone. Rather, it’s my expectation that the regulatory and development challenges, and the analytical, clinical, and commercial advances brought to light by biosimilars could see broader applications and open doors for the rest of the biopharma industry in the years to come.