Pfizer reports on biosimilar revenues and says its switching studies for Abrilada, an adalimumab biosimilar, support interchangeable status.
Pfizer officials said in an earnings call this week that they intend to seek interchangeable status for their adalimumab biosimilar (Abrilada) in a filing with the FDA in December 2021.
Interchangeable status has the potential to boost uptake of the product, which is scheduled to launch against 5 other adalimumab biosimilars in 2023. The interchangeable designation enables pharmacists to make the decision whether to dispense a biosimilar or a reference product rather than having to consult with the prescribing physicians.
Removal of that administrative step is considered a competitive edge for biosimilars, which although approved as being highly similar to reference products, with no clinically meaningful differences in safety or efficacy, don’t automatically receive interchangeable status.
Angela Hwang, group president for the Pfizer Biopharmaceuticals Group, said the company has completed interchangeable studies demonstrating that the adalimumab biosimilar can be interchanged multiple times for the originator product in patients, with no significant change in clinical outcomes.
Abrilada gained FDA approval in November 2019 but has been sitting on the shelf owing to a settlement between Pfizer and adalumumab originator (Humira) maker AbbVie. Most recently, Cyltezo, an adalimumab biosimilar also scheduled to launch in 2023, received interchangeable status from the FDA.
Partial earnings were reported for Pfizer’s biosimilars portfolio for the just-ended financial quarter. The company touted a 51% increase in “operational revenues” for its oncology biosimilars portfolio, which totaled $398 million, representing $284 million in US revenue and $98 million non-US revenue.
The company has multiple oncology biosimilars and supportive oncology biosimilars. In the former group are Ruxience (rituximab), Trazimera (trastuzumab), and Zirabev (bevacizumab). These were launched in 2019. The company also has Retracrit (epoetin alfa), Nivestym (filgrastim), and Nyvepria (pegfilgrastim), which enable patients to recover from blood-cell depletion following chemotherapy.
By contrast, Pfizer reported global biosimilar revenues of $424 million in the third quarter of 2020; and in terms of sequential revenues, the company reported global biosimilar operational revenues of $559 million for the second quarter of 2021.
Its biosimilar revenues in the third quarter of 2021 represented a portion of non–COVID-19–related revenues that were up 7%. When revenues for the company’s COVID-19 vaccine business are included, the total represents a 130% increase in revenues compared with the third quarter of 2020. Total third quarter 2021 revenues were $24.1 billion.
“While we are proud of our financial performance, we are even more proud of…what these financial results represent in terms of the positive impact we are having on human lives around the world,” Albert Bourla, chairman and CEO, said in the earnings call. “In the first 9 months of 2021, our innovative medicines and vaccines reached nearly 1 billion people. It's fair to say millions of lives have been saved because of [the COVID-19 vaccine, Comirnaty].”
Bourla said that excluding COVID-19 vaccinations, the company’s medications reached 300 million individuals during that period.
Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings
May 16th 2024Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states, as well as cost savings.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches
May 14th 2024The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Review: Product Attributes Relevant to Injection-Site Pain, Adalimumab Treatment
May 4th 2024A review article summarizes the product attributes of reference and biosimilar adalimumab products, such as formulation with or without citrate, delivery volume, and needle gauge, relevant to patients’ experience of injection-site pain.