4 Takeaways From The World Biosimilar Congress
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
Last week, I made the long trek from Erie, PA (which was oddly sunny) over to a surprisingly cloudy and cool San Diego for the World Biosimilar Congress USA. Though small, the event drew attendees and speakers from some of the forefront biopharma companies and payers in the industry, including Baxalta (soon to be Shire), Boehringer Ingelheim, Express Scripts, Harvest Moon, Merck, and Pfenex. Throughout the whirlwind two-day event, the panelists addressed the challenges of patient education and uptake, the pharmacovigilance of biosimilars, and how to navigate varying regulatory requirements in the global market. But there were four key messages relayed throughout this conference that are worth noting.
- U.S. Payer Uptake Will Rely On More Than PD & PK
It shouldn’t be a surprise for anyone involved in drug development that a company needs to begin thinking of commercialization as early as possible. In fact, in his panel, Express Scripts Chief Medical Officer (CMO) Steve Miller argued that one of the biggest hurdles for biosimilar makers will be working with a payer to create a sustainable biosimilar business. Miller emphasized that companies need to present payers with more than just the clinical data that is submitted to the FDA. The manufacturer-payer relationship needs to be a collaborative one, he described. When submitting a biosimilar to the FDA, the clinical data for pharmacodynamics and pharmacokinetics are stressed. But the payer throws a separate term into the mix: pharmacoeconomic data. Real-world experience, especially from Western countries — in particular, the EU, Japan, and Australia — as opposed to less-advanced countries will be important data to share. The payer also wants to know why they should prefer the biosimilar over some of the top products on the market, as well as how the company plans to support the biosimilar. As Miller described, the payer-company relationship for biosimilars is defined by the question: How will we work together to ensure the product is embraced by payers, patients, and physicians?
- Biobetters Might Have Better In Their Name, But…
Biobetters were on the tip of everyone’s tongues at this conference. As biosimilars are approaching the market, reference product makers have been pursuing biobetters to protect their top products and remain competitive. For instance, Genetech is making headway on its new anti-CD20 mAb, which is expected to be a biobetter to rituximab. Pursuits such as this have begged the question of whether biosimilars will end up being second line treatments to biobetters.
According to a panel of payers, there will likely be a heterogeneous market for biobetters. While companies with highly innovative treatments might steal the limelight for a time, longevity of this reign is not guaranteed. Payers are increasingly pushing for knowledge on how a product outperforms the best treatment on the market. In the past, treatments would be compared against a placebo in clinical trials, rather than against the market’s best treatment. However, now payers are becoming more stringent with the data required to show superiority. You can “win the game” if you can prove that your product is superior, Miller explains. But as Kaiser Permanente’s Doug Monroe says, to date, payers are primarily “beleaguered” by placebo-based trials. This could mean that newer treatments lacking the sought-after comparability information will end up in a lower position on the formulary.
- Biosimilars Production Costs Are Lower Than Ever
We’re bombarded by discussions about the price of manufacturing biologics — especially as biosimilars begin entering the market with higher price tags than small molecule generics. In his panel, the event’s moderator, Rich DiCicco, CEO of Harvest Moon, argued the cost of mAb development has decreased more than 50 percent in the past decade. While in 2006, it cost roughly $97.4 million to create a TNF-alpha mAb, it now costs in the ballpark of $43 million, thanks to new technology and more streamlined production procedures. In fact, biosimilar development could be as low $13 million should certain elements of the process be tweaked or eliminated altogether. (DiCicco’s panel was a goldmine of information and will be featured in a more detailed article in the coming weeks. For more on DiCicco’s unique role and presence at the conference, which went above-and-beyond the role of a typical conference moderator, be sure to read my colleague and fellow attendee Dan Schell’s response to the show.)
- Without Switching, Biosimilars Will Go Out Of Business
Perhaps one of the most highly-anticipated presentations was that of Dr. Steinar Madsen, the medical director of the Norwegian Medicines Agency. The originator discounts and uptake of biosimilars in Norway alone have certainly raised some eyebrows in this industry. But if there’s one thing to be sure of following his presentation, infliximab biosimilars have changed Scandinavian physicians’ views on switching for the better. In fact, Demark is expected to have an 80 percent uptake of the biosimilar within the next six months.
It goes without saying that many stakeholders — reference drug makers, regulators, physicians, patient organizations, and patients — harbor concerns about switching patients from the reference product to the biosimilar. As Quardricos Driskell, the health policy and federal affairs manager of the National Psoriasis Foundation expressed during his presentation, the act of switching from biologic to biosimilar is considered a change in therapy — a controversial notion to several in the show’s audience. However, when it comes down to it, multiple stakeholders at the show emphasized switching will be one of the biggest keys to the biosimilar market’s success.