By Anna Rose Welch, Director, Cell & Gene Collaborative
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As an industry, pharma is inundated with the term “innovation.” Patent laws and data exclusivity negotiations like the stalled Trans-Pacific Partnership (TPP) are centered around protecting innovation. Bayer recently established a team dedicated solely to pursuing innovation — though board member Kemal Malik was quick to tell Life Science Leader magazine that most people in the industry “have a tough time explaining [innovation].” Malik makes a good point here — innovation seems to have a different definition depending on whom you ask. As the biosimilar market takes shape in the U.S. (and still remains somewhat of a mystery), I’ve been curious about the way biosimilars might fit into or challenge current definitions of pharmaceutical innovation.
Biopharma Dive recently put together a series on innovation, inspired by the recent BIO conference. In an interview with Biopharma Dive, Sean Dalziel, managing director of Cleo Life Sciences, defined innovation as “a critical element in bringing about transformational change. For me, pharmaceutical product innovation is the intersection where a medical need is met with scientific ingenuity in a commercially relevant manner. This includes, but also goes beyond, the novelty aspects of an invention.” Dalziel’s definition seems straightforward, albeit broad: innovation extends beyond the noteworthy new molecular/scientific/clinical discovery of the drug itself and enters into the commercial realm where it should meet a medical and market need. Makes sense.
In the second article of this series, consulting firm Deloitte also offered its own definition of an innovative drug: One that “breaks the possibility frontier.” Innovative drugs “expand the range of possible outcomes while maintaining appropriate safety standards.” In terms of therapeutic area, Deloitte identifies orphan, neuroscience, and oncology drugs as being the most innovative in the current market. But to make the cut, these innovative drugs cannot be “me-too drugs,” even though following a review of the 35 “innovative” drug approvals from 2011 (aka new molecular entities granted priority review), Deloitte found that only seven actually earned the term “innovative.” The rest fell into the “me-too” category. Therefore, in order for a drug to be considered innovative, it must possess a unique mechanism of action and not just be more convenient or in a more patient-centric formulation. I can’t help but think of AbbVie’s Humira when considering Deloitte’s definition. Perhaps it’s the fact that Humira has seven indications and has been trying for eight that suggests this drug certainly “expands the range of possible outcomes.”
However, now that the industry has seen its first biosimilar approval and drugmakers have begun focusing on this noteworthy new type of medicine for the U.S. market, I’m left wondering where biosimilars fit into the innovation spectrum. Biosimilars require a complicated manufacturing process which leads to the formation of a drug which Fortune likens to “snowflakes” because of their different molecular makeups. Despite these molecular differences, however, these drugs need to produce the same response in the body as the reference product to make the cut as a biosimilar. If we consider the results from the Deloitte study mentioned earlier, the fact that a biosimilar is designed to mimic the mechanism of action would mean they don’t “break the possibility frontier.”
But if we step back from that definition, there are still ways I can see biosimilars fitting into this innovation paradigm — even though they are designed to be a “copy” (sort of) of an existing medication. After all, I’ve been met with headlines as of late that urge those working on biosimilar regulations and legislation to not treat biosimilars as generics, which share the exact same active pharmaceutical ingredients as the originator molecule. Just this week, BioPharma-Reporter described an effort underway by 30 members of Congress who submitted a letter urging the Centers for Medicare & Medicaid Services to rethink its reimbursement plan for biosimilars. The current plan, according to the letter’s authors, “treats biosimilars as if they are generic drugs,” which could lead to confusion and discourage the use of biosimilars.
I’d also like to take a step back from the finished biosimilar product and go back to the science and the process of making the drug. If being able to manipulate a molecular structure to produce the same response in the body as the reference biologic isn’t considered innovation, I’m not sure what can be. Let’s not forget that they’re clinically examined to maintain “appropriate safety standards,” are “commercially relevant,” and can help meet medical needs cost-effectively, in turn “expanding the range of possible outcomes”—in other words, fitting Deloitte’s and Dalziel’s definitions for innovation.
I should clarify that I have not come across anyone arguing that the biosimilar market or the development of biosimilars is not an innovative process or development. But it does seem that, as the industry struggles to come to a consensus about how to name these new treatments, it is walking a fine line between labeling them as a copy of an existing drug or as a unique player on the market. While generic drugmakers are pushing for biosimilars to carry the same International Nonproprietary Name (INN), brand name manufacturers argue that biosimilars, because of their molecular differences from the reference drug, should carry a different name. So, even though it has not been explicitly stated that biosimilars do or do not fit the innovation paradigm, it seems to me that many of the ongoing discussions surrounding extrapolation, interchangeability, and naming indicate the industry’s ongoing struggle to determine where exactly biosimilars fall on the innovation spectrum.