In the mass of adalimumab launches in July, it may be tough to spot the one missing player. This is not a game of Where’s Waldo? but rather, where’s Pfizer’s Abrilada™? Well, that’s a good question. Of the competitors that have gained FDA approval, they are the only manufacturer that did not launch its product last month.
I listened to Pfizer’s second-quarter earnings call on August 1 to see if the executive team would provide any updates. Unsurprisingly, the call focused on its COVID-19 treatments and vaccines, which had provided a “shot in the arm” (sorry!) to the company’s bottom line for the last couple of years but whose continued contributions are expected to wane. Their second-quarter revenues were down more than 50% from the second quarter of 2022, largely due to COVID-19 trends. They did address other pipeline pharmaceuticals to some extent. However, there was no official mention of Abrilada’s launch, and during the Q&A phase, none of the queries addressed Pfizer’s biosimilar performance or commitment.
In the originally announced adalimumab biosimilar launch sequence, resulting from licensing agreements signed with AbbVie, Pfizer was to market Abrilada towards the back of the pack—in November 2023. However, the launch timing was radically changed with the signing of later agreements by newer competitors. This moved all second half launches up to July.
Status of Abrilada’s Interchangeability Designation
Somewhat conspicuously, Pfizer did not publish an announcement of its anticipated Abrilada launch in early July (or of its pricing). The company had filed a supplemental biosimilar licensing application with the FDA for the interchangeability designation for its high-concentration formula on February 25, 2022. Although no official notification has been provided, any delay in the interchangeability approval does not seem to be related to data issues. According to Steven L. Danehy, Pfizer’s Director of Global Media Relations, “The FDA completed its review of Pfizer’s application in the fourth quarter of 2022 and provisionally determined that Abrilada (adalimumab-afzb) met the standards as an interchangeable biosimilar to Humira® (adalimumab).”
He stated in an Email to BR&R, “The FDA has not provided a timeframe for the anticipated approval of the interchangeable designation, but Pfizer is continuing to work with the agency to understand its perspective in the context of its guidance on interchangeability and determine a path forward.”
In the meantime, Mr. Danehy did confirm that the company plans to launch Abrilada as a “citrate-free biosimilar to Humira late third quarter/early fourth quarter 2023.” It is possible that Pfizer is still formulating its launch plan based on the current discounts being offered by the competition or that confusion over Abrilada’s interchangeability status (or applicability or exclusivity) is causing the delay.
Still a Formidable Roster of Biosimilars
Pfizer’s biosimilars may not be major items on its asset sheet but they are still contributors to the bottom line, especially on the oncology side. Retacrit®’s (epoetin alfa) US revenues totaled $68 million for the second quarter (a decrease of 21%), and US sales accounted for more than three-quarters of Retacrit revenues globally. It remains the only epoetin biosimilar marketed in the US, which has prevented a precipitous drop in the net price of the product.
Ruxience® (rituximab) pulled in $84 million during this period, a decline of 18%; Zirabev® (bevacizumab) (dropped 25% to $74 million; and Trazimera® (trastuzumab) contributed only $12 million, a reduction of 48%.
Pay less attention to the decreases in revenues; this is what should happen in biosimilar-dominated categories that have been the subject of fierce competition over the past few years. They are not signs that Pfizer missed an opportunity.
Pfizer’s other marketed immunology biosimilar is the result of its collaboration with Celltrion—Inflectra®. Inflectra’s US revenues are “down 81%,” according to Pfizer, “primarily driven by lower net price as a result of unfavorable changes in channel mix.” In the second quarter, Inflectra (infliximab) pulled in $15 million in revenue in the US, but still $74 million globally (this too was down, by 46% over the same quarter in 2022). And the picture could be cloudier for this product, as Celltrion hopes to introduce its subcutaneous formulation of infliximab soon.
The revenues for Nyvestim®, its filgrastim biosimilar, and Nyvepria®, its pegfilgrastim biosimilar, were not broken out separately, likely because they did not reach a reporting threshold. According to sources, Nyvepria holds less than a 10% marketshare, as the net price of the category is down 70% over time. Nyvestim’s has 17% of the marketshare, with a similar decline in net prices.
Pfizer doesn’t list any new biosimilar research and development as part of its pipeline, but that may not be the full story. It signed a contract manufacturing deal with Samsung Biologics, in which Samsung will produce Pfizer’s biologics and biosimilars. Does this signal a step back from biosimilar development for Pfizer? Mr. Danehy stated, “Pfizer is a global leader in biosimilars, and we plan to leverage our in-depth commercial experience with both biosimilars and innovative products to continue to meet the needs of patients and healthcare professionals.”