Despite wishful predictions in the first years of the regulatory pathway, biosimilars have only lapped at the shoreline of the U.S. biologics market. But the tide is changing.
By the third quarter of next year, as many as 23 biosimilars could be approved by the FDA, Rob Jacobson, executive director of value & access – biosimilars/oncology at Amgen Inc., told BioWorld. That would more than double the number currently approved. And it could increase competition, putting pressure on the pricing of biologics that have had the sea to themselves for many years.
Of course, how that competition washes ashore will be determined by when those biosimilars launch and how many reference the same innovator. The 11 biosimilars already approved by the FDA reference eight innovators. Only three of the 11 are on the market – Sandoz Inc.'s Zarxio, a filgrastim biosimilar and the first biosimilar to be approved by the FDA, and two infliximab follow-ons, Pfizer Inc.'s Inflectra, licensed from Celltrion Inc., and Merck & Co. Inc.'s Renflexis, licensed from Samsung Bioepis Co. Ltd. In December, the FDA approved Pfizer's Ixifi as a third infliximab biosimilar, but the New York-based company has no plans to launch it in the U.S. in competition with Inflectra, which was part of its 2015 acquisition of Hospira Inc. (See BioWorld Today, Feb. 6, 2015.)
Two other follow-ons – Pfizer's Retacrit, an epoetin alfa biosimilar, and Mylan NV's pegfilgrastim biosimilar Fulphila – are expected to launch this year. While the timing of the U.S. launch of Retacrit depends on a number of factors, "we are moving ahead with the preparation of our launch plans for 2018," Thomas Biegi, director of Pfizer's global media relations, told BioWorld.
When it launches, Retacrit – which has been marketed in the EU for more than a decade, along with four other epoetin biosimilars – will be the first U.S. biosimilar to compete with Amgen's Epogen and Johnson & Johnson's (J&J) Procrit. (See EMA, FDA comparison of biosimilars approved, below.)
The launch of Mylan's Fulphila, referencing Amgen's Neulasta, is expected in the "coming weeks," the Hertfordshire, U.K., company said when the approval was announced earlier this month. It will be an at-risk launch, since Mylan is in a patent dance with Thousand Oaks, Calif.-based Amgen over two patents claiming methods of purifying proteins used in manufacturing biologics.
The other six biosimilars approved by the FDA are waiting for key patents on the reference biologics to expire or, in some instances, the outcome of ongoing patent litigation.
The expected swell in biosimilar approvals is what many policymakers and experts have been touting as key to lowering the nation's drug spend. But the tens or hundreds of billions of dollars in savings that have been projected since the 2010 Affordable Care Act paved the way for a U.S. biosimilar path may still not be in sight.
There are several reasons for that. "Given the evolving nature of the regulatory and competitive landscape of biosimilars, it is difficult to estimate the potential savings of biosimilar products," according to a recent Amgen report, Clinical and scientific considerations for biosimilars. Proposed changes in Medicare reimbursement and other parts of the president's blueprint to lower prescription drug prices could change the shoreline even more, but that's another story.
The idea behind biosimilar competition is that it would have a similar pricing pressure on biologics as generics have had on small-molecule drugs in the U.S. But with only three biosimilars on the market, the follow-ons haven't had much of an impact on the overall biologics spend. The first two launched at about a 15 percent discount from the list price of the reference biologic, compared with the 20 percent to 30 percent discount seen for the first biosimilar to a given biologic in the EU. (See BioWorld Today, Oct. 19, 2016.)
However, the average sales price (ASP) is more relevant than the list price, Jacobson said, noting that two of those three biosimilars initially set their price at the ASP of the reference biologic, and the other one was set higher than the prevailing ASP. Such pricing presents little incentive to switch to a biosimilar.
Since that time, though, the two infliximab biosimilars have significantly undercut the ASP of the reference biologic, J&J's Remicade. Inflectra's per dose ASP for the third quarter of 2018 is $602.30, compared with $644.73 for Renflexis and $791.50 for the innovator. "Biosimilars have great opportunity to generate savings," Biegi said. But payers have to cover them and doctors have to prescribe them.
Even though Remicade's third-quarter ASP is higher than the price of Inflectra at the time of its launch in 2016 and Inflectra's ASP is now nearly $200 cheaper than Remicade, J&J's "exclusionary contracting" keeps Inflectra at a disadvantage in the market, Biegi said.
Despite the challenges to competing on the U.S. market, the first wave of biosimilars is growing in the U.S., as the number approved seems to be increasing every year. Meanwhile, the EU looks to be on its second wave, following a lull between 2011 and 2012. This wave is making a bigger splash than the first, which crested in 2007 with the five epoetin alfa biosimilars. Last year, the EMA approved 16 biosimilars, including six referencing Roche Holding AG's Mabthera/Rituxan (rituximab) and four biosimilars to Abbvie Inc.'s mega-blockbuster Humira (adalimumab). (See EMA, FDA biosimilar approvals by year, below.)
Amgen snagged the first EU approval for a Humira biosimilar with its Amgevita, which it's planning to launch Oct. 16. Although Amgen is expecting other biosimilar competition, Amgevita will be right at the front and will be well-positioned, Chad Pettit, executive director of global value & access – biosimilars at Amgen, told BioWorld.
Although Amgen's biosimilar was approved by the FDA in 2016 as Amjevita, it won't launch in the U.S. until 2023 under a patent settlement with Abbvie. (See BioWorld Today, Sept. 27, 2016.)