Drug Price Forecast Shows Biosimilars at a Tipping Point

Biosimilars have reached a tipping point in the US market, according to a new drug pricing forecast from consulting company Vizient.

The forecast, which presents the Vizient pharmacy team’s best estimate of likely drug price behavior for the coming year, projects significant increases to the prices of originator biologics: antineoplastic agents, including bevacizumab and rituximab, are expected to see a class-wide price increase of 4.96%. Biologic disease-modifying anti-rheumatic drugs, such as etanercept, adalimumab, and infliximab, are expected to rise by 11.95%.

Steven Lucio, PharmD, BCPS, associate vice president of clinical solutions and pharmacy program development for Vizient, told The Center for Biosimilars^® in an interview that “Manufacturers are trying to get as much value, within reason, as they can...whether it’s the Enbrels or the Humiras or the Keytrudas and the Opdivos, it varies year to year, but [we] can guarantee a 5% to 8% increase. That’s why we need biosimilars.”

The report highlights AbbVie’s recent settlement with Amgen over the latter’s Amgevita, a biosimilar of Humira, as a key development in the biosimilars marketplace that will have an impact on the industry in the days ahead. The settlement, which ended a lengthy patent infringement litigation, will allow Amgen to begin selling its drug in the United States in 2023.

Stakeholders have debated whether this settlement was a win for biosimilar developers seeking market entry for their products or for reference product sponsors who hope to hold on to market share for as long as possible. Lucio says, “It is what it is...It’s negative in that we’re still so many years away, it’s a positive in terms of giving more clarity into when [market] entry is likely to happen. It gives you a window to know what you’re up against.”

Lucio says that the long timeline before product entry could potentially benefit Amgen, as it allows the biosimilar developer time to allow payers to adjust their policies on biosimilars before launching Amgevita.

The performance of biosimilars that have entered the market thus far, including the infliximab biosimilars Inflectra and Renflexis, suggests that payer policies do need to further evolve if biosimilars are to thrive in the US market; the report notes that, based on its member data and data from consulting company IQVIA, approximately 99% of infliximab purchases are of the originator drug, Johnson & Johnson’s Remicade.

Yet that 1% market share for biosimilars may not be as discouraging at it appears, according to Lucio. “It just takes a long time for these products to get in the pathway [for adoption],” he said, adding that many of the hospitals with which he has worked have been reluctant to even discuss adding a biosimilar to a formulary before pricing or distribution issues are settled. Given how much expense and effort are required to bring a biosimilar onboard, biosimilar adoption is a slow process, says Lucio. “It’s fine to feel disappointment, but don’t give up right now. In 2018, there can be a difference made with Inflectra and Renflexis.”

In the case of filgrastim, for which a biosimilar (Zarxio) and a follow-on (Granix) have been available longer, the reference Neupogen still retains about 70% of the market, according to the report. While a 30% market share for lower-cost options may be an underwhelming figure for some stakeholders, Lucio sees the issue differently: “It’s a function of the market that is different...they just want to capture a segment of the market. [They’re] not looking to dominate the whole thing.” Biosimilar and follow-on developers may not want to have to supply the entire market’s demand for filgrastim, explained Lucio, adding that “They’re not trying to eliminate [Johnson & Johnson].”

Looking ahead, the report suggests that the entry of anticancer biosimilars in the United States has the potential to spur real competition for high-cost drugs. Vizient projects that 2 rituximab products (Celltrion and Teva’s CT-P10 and Sandoz’s proposed biosimilar) and 2 additional trastuzumab biosimilars (Celltrion and Teva’s CT-P6 and Pfizer’s PF-05280014, which would join Mylan and Biocon’s already approved biosimilar, Ogivri) could be approved by the FDA in the first half of 2018.

While these products would likely launch no sooner than 2019, says Lucio, “The thing that really would help is having at least 2 competitors on the market at the same time, that enter the market really close [together].” The industry has learned from the slow acceptance of biosimilars in the inflammatory disease space that “1 is not enough to do it … for the benefit of the healthcare system, you want to have multiple competitors. Three molecules—the originator and 2 biosimilars.”

In looking ahead, Lucio urges stakeholders not to lose faith in the potential of biosimilars because of their slow start in the United States. “[I’m] encouraging people not to lose heart and really focus their attention right now,” he said. If biosimilars for therapies like infliximab can succeed in the US marketplace, “It shouldn’t be as heavy of a lift in 2029 when Opdivo or Keytruda face biosimilar competition.”