A Quick Look Back: Why We Misread the Signs

In the biosimilars arena, at least in the US, history seems to be truncated. Policy changes occur in rapid fire succession these days, and access scenarios don’t evolve—they just happen or they don’t! Along this brief journey, I’ve taken the opportunity to focus on some of the sign posts that were exceedingly poor maps for navigating the future.

One of the first blogs I wrote for The Center for Biosimilars in early 2016, involved a defeat for Amgen in its patent litigation with AbbVie regarding Humira®. No one was sure what the implications of this decision would be. Amgen was on the road to gaining approval of the first biosimilar adalimumab. The payer and investment community sensed momentum building towards the imminent takedown of the number 1 biologic in terms of sales. I referenced 2016 Humira revenue estimates of $14 billion for AbbVie, and mentioned two other prospective biosimilar makers—Baxalta and Momenta—being hot on Amgen’s heels.

In that same article, many in the investment community was under the belief that a US marketed adalimumab biosimilar would be available by 2020. Instead, January 2023 is looking more inevitable. I wrote, “The investment community believes that Amgen will come out on top; they believe that AbbVie will have $6 billion—not $18 billion—in Humira sales by 2020.”

I’m not sure that I could have been more wrong in my assumptions or sentiments, thinking that AbbVie’s maze of 70 patents (at the time) could be severely damaged at that time by the process to challenge patents. This may happen today through Boehringer’s efforts, but I wouldn’t count on it. The other major players don’t have the stomach for fighting this battle.

In 2017, Baxalta and Momenta have dropped out of the biosimilar contention for Humira’s marketshare, replaced by Sandoz, Boehringer, Coherus, Samsung Bioepis, and perhaps others. Baxalta and Momenta , one being taken over by Shire and the other facing financial realities.

Unfortunately, it will take a miracle, in the form of a Boehringer victory or even less likely, adoption of Dr. Peter Bach’s biologic pricing proposal, to get adalimumab to the payer market. The fact that the proposal that Dr. Bach and his colleagues at Memorial Sloan Kettering laid out received as much attention as it did tells quite a bit about our serious frustration today with access to biosimilar savings.

Of course, very few actions taken by the current Administration have yet to be implemented. These are intended to bolster the biosimilar industry and move from promised to actual savings. However, the signs are telling me that we’re not in an evolutionary phase of biosimilar development–an extinction event may be around the corner.

Coherus Readying to Resubmit Its Pegfilgrastim Application

News about Coherus Biosciences has been limited since the Food and Drug Administration (FDA) rejected its initial application for a pegfilgrastim biosimilar last June. However, at this year’s JP Morgan Healthcare Conference in San Francisco, Coherus issued some positive signs of progress.

According to Dennis Lanfear, Chief Executive Officer, the company is getting ready to resubmit its 351(k) application for pegfilgrastim (CHS-1701). The FDA had cited worries about immunogenicity of the agent and specifically with Coherus’ assay to evaluate immunogenicity in its complete response letter, along with potential manufacturing plant problems.

Mr. Lanfear believes that resubmission in the first quarter of this year will yield an FDA decision before the fourth quarter. In addition, Coherus is hoping to receive European Medicines Agency marketing approval prior to this timeframe.

Coherus still has other prospects in the biosimilar arena: Its version of adalimumab is subject to patent litigation (of course), but it should receive a decision on its inter parties review motion regarding its etanercept biosimilar in March of this year.

These would be very hopeful signs after the company’s poor fortunes in 2016 and 2017. It lost its marketing partner in Baxalta (then Shire), and after receiving the FDA rejection on pegfilgrastim last year, it had cut its workforce by 30%.