Pfizer Changes to "Opportunistic" Stance on Biosimilars

August 17, 2021

After the loss of a manufacturing plant in China and a knock-down-drag-out battle with Johnson & Johnson, is Pfizer cooling on biosimilars?

If biosimilars development and sales have lost some of their luster for Pfizer, it’s understandable, given the tremendous boost to the bottom line the company has received from its COVID-19 vaccine. The Pfizer-BioNTech COVID-19 vaccine contributed $7.8 billion in revenues during the second quarter of 2021, and the company said in its earnings report that its vaccine business was just getting started, with new contracts being signed for delivery around the globe.

The vaccine paycheck literally dwarfed the company’s biosimilars revenue—$559 million for the second quarter of 2021, even though this was up 88% compared with the same quarter a year ago. However, in its earnings discussion, the company said it was not actively seeking to expand its biosimilars product portfolio and saw more attractive opportunities in pharmaceutical development elsewhere, particularly in innovative, or novel, medicines.

“Certainly, we've been so pleased with the tremendous growth that we've seen [for biosimilars] and the deep utilization of our biosimilars,” said Angela Hwang, MBA, group president of Pfizer’s Biopharmaceuticals Group. “We've made [a] pivot to a pure play sort of innovation focus in our pipeline. We are really now looking at that biosimilar portfolio vis-à-vis other investments in breakthrough therapies. We will continue to look for opportunities, but I would say at this point it’s going to be more opportunistic.”

And if that wasn’t clear enough, Albert Bourla, PhD, chairman and CEO, explained in the same conference call that Pfizer can afford to be choosy about its investments and is putting its money on original medicines. “Right now, we are clearly focusing on first-in-class, and particularly, best-in-class first-in-class.”

Pfizer's Pipeline

At the moment, Pfizer does not have any biosimilars in its development pipeline. Bourla said the company is especially interested in developing Janus kinase (JAK) inhibitors for treatment of inflammation. It has 2 JAK inhibitors in the FDA submission (registration) stage currently (abrocitinib, PF-04965842; tofacitinib, Xeljanz), for atopic dermatitis and ankylosing spondylitis, respectively, and 1 in phase 3 clinical development (ritlecitinib, PF-06651600), for alopecia areata, although these are not biosimilars.

Pfizer has multiple other products under the internal medicine, rare disease, and oncology headings that are in the phase 3 or registration stages of development, as well as development-stage vaccines for COVID-19, pneumococcal infections, and tick-borne encephalitis. Again, these are not biosimilars.

Not as far along in development, and also not a biosimilar, is a Lyme disease vaccine, in phase 2 clinical development, which Pfizer is co-developing with Valneva. The companies are seeking to determine the optimal dosing schedule to be applied in a phase 3 study, which would potentially initiate in the first half of 2022.

Pfizer last launched new biosimilars in late 2019 and 2020, when it began the marketing of bevacizumab (Zirabev), rituximab (Ruxience), and trastuzumab (Trazimera) biosimilars.

Pfizer’s commitment to biosimilars was challenged from the beginning, when in 2017 it launched the infliximab biosimilar Inflectra and immediately ran into a barrage of tactics from Johnson & Johnson that, Pfizer claimed, effectively stunted sales growth for Inflectra. Biosimilars in the infliximab class became the worst-performing group by market share. Although infliximab biosimilars were launched as early as 2017, they had taken just a 23% market share from the reference product, Remicade, by the first quarter of 2021. Biosimilars in other categories had done far better, with filgrastim biosimilars doing the best (73% market share).

In a legal battle with J&J over Inflectra’s weak launch, Pfizer alleged anticompetitive practices; in particular, Pfizer alleged that J&J was strong-arming payers by threatening to withhold rebates unless they agreed to “biosimilar exclusion” contracts. The case was resolved in July 2021 with an undisclosed settlement between the litigants; and although Pfizer said it was going to stick it out in the inflectra biosimilar business, it has been hard-earned money compared with the COVID-19 windfall.

Upjohn Spinoff

Despite the positive biosimilar revenues this past quarter and the lukewarm interest in developing further biosimilars, Pfizer has been at wider extremes in the past year in its commitment to this class of biologics. The company clung tight to its biosimilars portfolio when it spun off its Upjohn division to Viatris, which represents the combined forces of Upjohn and Mylan, a biosimilars development company with at least 20 biosimilars and insulin analogs in its portfolio. The move suggests Pfizer clearly values the biosimilars it has.

The Upjohn division trade included Lipitor (atavastin), the blockbuster cholesterol drug; and Viagra (sildenafif citrate), the popular erectile dysfunction drug.

But in May, Pfizer announced it was abandoning its biosimilars manufacturing plant in Hangzhou, China. Starting in 2016, the company had begun a $350 million investment to develop the plant for the sake of producing biosimilars for the China market. The company did an about-face this spring, when it announced it had reached the “difficult decision” to pull out of that investment and sell the entire plant to China-based WuXi Biologics, a biopharmaceutical company with global activities.

And this time last year, New York-based Pfizer was publicly expressing disappointment with the state of the biosimilars market in the United States. “The big story is the low uptake of biosimilars in the United States,” said Juliana Reed, MS, a vice president and Global Corporate Affairs lead for Pfizer, in a presentation for the Pacific Business Group on Health and the Integrated Benefits Institute. Although the United States consumes 60% of the biologics produced globally, 90% of biosimilar sales occur in the European Union, Reed said.

“We know we have to address anticompetitive behaviors that disincentivize the uptake of biosimilars, but we also need proactive policies that incentivize the uptake of biosimilars," Reed said.