Pfizer to Seek Interchangeable Status for Abrilada Biosimilar

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.

Albert Bourla, Pfizer chairman and CEO

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.