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pfizer biosimilars growth

Pfizer Inc.saw its biosimilars segment jump 80% in operational growth and 79% as reported in the third quarter of 2020, clocking sales of $424m compared to $236m recorded in the prior-year period.

While Pfizer’s US biosimilars reported revenues of $260m, developed Europe earned $122m, the developed rest of the world region generated $20m and emerging markets earned $21m.

The firm credited recent oncology launches of Ruxience (rituximab), Zirabev (bevacizumab), Trazimera (trastuzumab) and Retacrit (epoetin zeta) in the US and other global markets for the growth in its biosimilars business. (Also see "Pfizer Lines Up Trio Of US Biosimilar Launches" - Generics Bulletin, 31 Oct, 2019.)

Meanwhile, the company’s sterile injectables business saw global revenues drop by 4% as reported and by 3% on an operational basis to $1.19bn in the third quarter of 2020, compared to $1.24bn in 2019. While US sales for Pfizer’s sterile injectables business clocked in at $586m – up by 2% – international markets earned $610m, a drop of almost a tenth.

Overall Biopharma Sales Up By 4%

Overall, Pfizer reported 4% operational growth from its Biopharma business in the third quarter, with its revenues totalling $10.2bn. The company said that the growth was primarily driven by “the ongoing strong performance” of tafamidis-based Vyndaqel/Vyndamax that reported 101% growth in the US and 150% growth in international markets.

Frank D’Amelio, chief financial officer of Pfizer, said “in the first nine months of the year, our biopharma business grew 7% operationally, despite a COVID-19 related negative impact of approximately 2%, driven by the strong performance of many of our key brands.”

“This performance adds to our confidence in our ability to achieve our expectation of at least a 6% compound annual revenue growth rate through 2025 for New Pfizer,” following the separation from the Upjohn off-patent and mature brands unit that is set to merge with Mylan imminently.

Albert Bourla, chairman and CEO of Pfizer, said he was “more confident than ever in Pfizer’s future as we transition to a smaller, more agile, science-based pharmaceutical company with what we believe is an industry-leading innovative pipeline.”

According to the company, “New Pfizer” will exclude contributions from Pfizer’s Meridian subsidiary and the Pfizer-Mylan strategic collaboration in Japan.

Expects To Close Upjohn Transaction With Mylan In Q4

Pfizer reaffirmed that it is expecting to close the Upjohn transaction with Mylan in the final quarter of 2020.

Just last month, the European Commission gave its final approval for the proposed combination of Mylan and Pfizer’s Upjohn business into Viatris, after giving the green light to Mylan’s suggested list of buyers for divestitures. (Also see "Mylan And Upjohn Combination Takes Key Step To Completion" - Generics Bulletin, 16 Sep, 2020.) This came shortly after agreeing to divest three mature Upjohn brands in Australia. (Also see "Upjohn To Divest Three In Australia To Complete On Viatris" - Generics Bulletin, 10 Sep, 2020.)

Pfizer’s Upjohn unit reported a drop of 18% in revenues to $1.9bn for the third quarter of 2020. The firm blamed “multi-source generic competition that began in July 2019” for the volume declines for generic Lyrica (pregabalin) in the US. The company also saw lower volume for Celebrex (celecoxib) in Japan and lower revenues for Lipitor (atorvastatin) and Norvasc (amlodipine) in China due to the impact of the volume-based procurement program.

Third Quarter Performance

In total, Pfizer saw a 4% drop in global revenues to $12.2bn for the third quarter of 2020, representing a decrease of $549m compared to the prior-year quarter. The company also recorded the unfavorable impact of foreign exchange rates of $104m or 1% during the third quarter.

The company’s third-quarter results also included “an estimated unfavorable impact of approximately $500m or 4%, due to COVID-19.”

Commending the company on being able to maintain supply despite the pandemic, D’Amelio said “I am pleased with our performance so far this year, including our ability to maintain a steady supply of medicines to the patients who rely on them around the world during these uniquely challenging times.”

With the pandemic in view, Pfizer has “updated and tightened” ranges for its financial guidance for 2020 considering the actual and anticipated impact of COVID-19. The company’s updated financial guidance will look at various uncertainties, primarily those related to the severity, duration and global macroeconomic impact of the pandemic.

Total sales are forecast to be between $48.8bn and $49.5bn, with $40.8bn-$42.4bn attributable to “New Pfizer” and $8.0bn-$8.5bn to Upjohn.

“Current guidance continues to assume no revenue contributions from a potential COVID-19 vaccine,” stated Pfizer.

Commenting on the “historically challenging year,” Bourla said, “I could not be more proud of the extraordinary effort, dedication and resolve shown by Pfizer colleagues to address the COVID-19 pandemic with unprecedented speed, while never compromising on their commitment to the patient-centered, science-driven standards that guide everything we do.”

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