While Amgen fends off etanercept biosimilar competition in the United States, Pfizer said it is facing a mounting battle against biosimilar competition in European and other markets.
Biopharma revenue climbed for Pfizer in the second quarter of this year, although revenue dipped for Enbrel, the etanercept reference product for rheumatoid arthritis.
Pfizer holds rights to distribute Enbrel in Europe as well as other markets outside the United States where patents on the drug have expired and it faces biosimilar competition, such as in Japan and Brazil.
Without providing an exact dollar figure, the company said operational revenues for Enbrel were down 16%. Overall, 2020 second-quarter biopharma revenues were $9.8 billion, up 4% from $9.4 billion in the second quarter of 2019.
Amgen holds rights to distribute Enbrel in the US market, where patent protections remain in force and competition is not anticipated before 2029. Most recently, Amgen secured its Enbrel foothold in the United States with a court ruling that rebuffed attempts by Sandoz to invalidate Enbrel patents.
Sandoz and Samsung Bioepis both have FDA approvals to market biosimilar versions of etanercept but have been restrained by Enbrel's exclusivity rights. Both have challenged those patents.
Pfizer Readies Launch of New Biosimilar
During the quarter just ended, Pfizer gained FDA approval for pegfilgrastim biosimilar Nyvepria, which references Neulasta. Pegfilgrastim is indicated for controlling infection related to febrile neutropenia in patients receiving chemotherapy.
A 2020 launch is anticipated for Nyvepria, although an exact date has not been announced.
In its financial guidance, Pfizer said that competition from generic and biosimilar products will have an overall negative affect on revenues of $2.4 billion in 2020, based on an assessment of Pfizer products that have recently lost or are expected to lose patent protection.
In sum, Pfizer reported second-quarter 2020 revenues of $11.8 billion, down 11% from $13.3 billion in 2019.
The company said the pandemic has not significantly affected its supply chain, and it has scaled up its manufacturing operations to supply a potential novel treatment or vaccine for coronavirus disease 2019.
Like many others, Pfizer paused its clinical trial recruitments in the early months of the pandemic, but it has since restarted enrollment across its drug development portfolio and begun new studies, utilizing remote monitoring and careful coordination with clinical trial sites to accommodate safety needs amid the virus outbreak.
The company said that its sales personnel were able to meet in-person with doctors for nearly the entire second quarter in international markets, whereas this was not possible for most of the 3-month financial reporting period in the United States.