Biosimilar Evolutions To Watch For In The New Year
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
In a recent article, I highlighted a few “traditions” (or at least burgeoning trends) in the biosimilar industry that could stand to see some changes in the upcoming years. In addition to sharing concerns about excessive regulatory caution, ongoing commercialization misconceptions, and patent estates, a handful of experts provided me with a wealth of forward-looking information that was too good not to share. Here, experts from Adello Biologics, PA Consulting Group, Momenta Pharmaceuticals, and Avalere Health, share which trends and challenges they’re watching closely, along with how the industry could “break from tradition” in the next few years.
What new biosimilar trends should companies pay attention to in 2018? What impact do you feel these will have on the industry moving forward?
We’ve been closely watching the arrival of Indian biosimilar companies’ products in the U.S. Until now, we believed Indian companies would have a hard time competing in more mature markets like the EU and U.S. because of the lack of IP protection and regulatory rigor in the production. However, recent FDA approvals of manufacturing plants and approval of Biocon’s trastuzumab biosimilar may be the first steps to proving us wrong.
— Chris Isler & Magnus Franzen, life science experts, PA Consulting Group
Litigation in the U.S. will continue to heat up as we see more biosimilar applications accepted by the FDA. This will lead to increased risks for biosimilar developers. For instance, we saw Hospira ordered to pay $70 million in damages to Amgen for stockpiling product for launch before the relevant patents had expired. We also anticipate more companies settling outside of court, similar to AbbVie and Amgen. This leaves questionable patents unchallenged, and every biosimilar developer is then forced to repeat the exercise of legal action and eventual settlement to bring their product to market.
—Peter Moesta, CEO, Adello Biologics
Development costs for a biosimilar are about 100 times that for the average generic (as in $100 million to $500 million versus $1 million to $5 million) and are continuing to climb. Sponsors are already trimming their pipelines based on development costs. Were a clear commercial model(s) for biosimilar to emerge, that might settle and sustain investment, but I am not sure that will emerge in 2018. I expect a mix of generic (savings) and brand (detailing, patient assistance programs) expectations for biosimilars to continue and for different business models to emerge commercially for products used in different settings of care and for different indications.
—Gillian Woollett, SVP, Avalere Health
The data in this market research report includes perspectives from outsourced manufacturing decision makers involving the selling and manufacturing of biosimilars, their expectations regarding how much biosimilar manufacturing is expected to be outsourced, how they feel about outsourcing to particular CMOs, and some of the bigger challenges involved in biosimilar manufacturing.
In what particular way(s) will biosimilar companies need to break from tradition in 2018?
Two ways companies are thinking differently about biosimilars and are trying to differentiate from the competition are in customer experience of the product and customer engagement. For instance, Biogen’s development of a device superior to Amgen’s Enbrel device is an example of how a company can differentiate with the experience of the product, while maintaining biosimilarity.
When thinking about biosimilar customer engagement, we believe companies will have to develop their view of the role of channels — though this will of course be highly market-dependent. In the U.S., we’re watching the role of pharmacy benefit managers (PBMs). Similarly, in Europe, the central procurement teams of integrated wholesalers like McKesson-Celesio may come to push the market in certain directions.
Some of the big players in the biosimilar space may not traditionally have had a strong channel focus, but will have to develop new capabilities to engage effectively with certain customer groups.
—Chris Isler & Magnus Franzen, life science experts, PA Consulting Group
The goal of a biosimilar is to increase affordable access to important treatments. In order to do so, they simply cannot be developed in the same way as the reference brand. The concept of biosimilarity is science-based; if the molecule matches the critical quality attributes of the reference product, it can be expected to have the same efficacy and safety profile. As we continue to get more comfortable with the science, I expect the industry will see the clinical package that accompanies an approved biosimilar become more tailored and without lengthy and expensive “traditional” Phase 3 clinical trials.
—Peter Moesta, CEO, Adello Biologics
While savings in development can help promote affordability, innovation in manufacturing may also be essential to provide competitive, affordable access over the long term. When you're in a biosimilar world, you cannot always accurately estimate your future market share, but what you do know is if you have a large addressable opportunity for market share and you do not have the capacity, you will most likely leave the majority of your profits on the table.
In the early days, companies sought to replicate the large-scale, historic process of the reference product. Innovation may allow for use of more efficient manufacturing processes. For example, we anticipate greater reliance on flexible manufacturing that allows for scalable banks of manufacturing capacity. In addition, we anticipate that analytical characterization, when applied in manufacturing process development, can enable the use of higher-yield modern production systems to manufacture biosimilars more efficiently.
— Bruce Leicher, SVP and general counsel, Momenta Pharmaceuticals, and chair of the board of The Biosimilars Council