Tony Hagen is senior managing editor for The Center for Biosimilars®.
Pfizer is battling biosimilar competition as its brands lose exclusivity but it is fighting fire with fire, launching multiple biosimilars of its own. Biogen has extended its commercialization agreements for biosimilars and said its earnings picture improved in the first quarter of 2020.
Biosimilar earnings climbed by the double digits for Biogen and Pfizer during the first quarter of 2020. Pfizer has introduced multiple biosimilars in recent months, although it also anticipates that biosimilar competition will erode its earnings base significantly.
Biogen has extended its commercialization agreements for biosimilars and said sales of biosimilars to treat coronavirus disease 2019 (COVID-19) improved the earnings picture in the first quarter of 2020.
Pfizer reported that its biosimilar revenues climbed to $288 million in the first quarter, up 63%. That breaks down to $167 million in the US market and $122 million internationally.
The company attributed much of the increase to steady growth of sales in the United States, particularly for its epoetin alfa biosimilar Retacrit, which references Amgen’s Epogen. Retacrit’s US market first-quarter revenues were up 363%, the company said.
Pfizer said its infliximab biosimilar Inflectra, which it markets under an agreement with Celltrion, saw US sales increase 46% to $84 million, driven by higher demand but also affected by product price declines. Worldwide sales of the product were $158 million, up 14%.
Pfizer has been highly active launching therapeutic monoclonal antibody oncology biosimilars. It put a rituximab product on the US market, Ruxience. That was in January. In February the company launched Trazimera, a trastuzumab product. In December 2019, Pfizer launched the bevacizumab biosimilar Zirabev.
“We are encouraged by our initial engagements with payers and providers, where we have not seen the negative impact of exclusionary contracting by the innovator companies that we had seen with the Inflectra launch,” company chairman and chief executive officer Albert Bourla said about the launches in an earnings call.
On April 2, Pfizer announced that the European Commission had approved its rituximab monoclonal antibody, Ruxience, for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other disorders.
It wasn’t all rosy for Pfizer on the biosimilar front. The company said its sales of reference etanercept Enbrel were hit hard by biosimilar competition in European markets, Brazil, and Japan. Sales were off 21% for the quarter.
In providing guidance for investors for the full year 2020, Pfizer warned of an anticipated $2.4 billion “negative revenue impact” due to recent and expected generic and biosimilar competition for products that have recently lost or will soon lose patent protection.
Biogen reported biosimilars earnings of $219 million for the first quarter, up 25% compared with the year-ago comparable quarter, an increase of $44 million. The company said its anti—tumor necrosis factor (TNF) biosimilars have been used to combat COVID-19 and it attributed $15 million of its first-quarter earnings to this.
The company estimated that its biosimilar business in Europe led to a savings of roughly $2 billion for the healthcare systems. Biogen said it has 215,000 patients using its biosimilars in Europe. The company does not yet market any biosimilars in the United States.
Biogen has a commercialization agreement with Samsung Bioepis to market the Republic of Korea—based company’s 3 anti-TNF biosimilars: Flixabi, Imraldi, and Benepali.
The infliximab biosimilar Flixabi saw revenues reach $24 million in the first quarter of 2020, up from $15 million in the first quarter of 2019. The adalumumab biosimilar Imraldi achieved first-quarter 2020 revenues of $62 million, up nearly 100% from $36 million in the year-ago quarter. The rheumatoid arthritis biosimilar Benepali was the top performer, achieving first-quarter revenues of $133 million, up from $124 million in the year-ago quarter.
Benepali is the overall top-selling biosimilar to reference Enbrel in the EU5 markets, which include France, Germany, Italy, Spain, and the United Kingdom, Biogen said.
In late 2019, Biogen notched a commercialization agreement with Samsung Bioepis for SB11, a ranibizumab biosimilar referencing Novartis’ Lucentis, and the aflibercept biosimilar SB15, referencing Eylea, by Regeneron. Both products are for age-related macular degeneration. These 2 reference products had a global market of almost $11 billion in 2018, according to Biogen.
The company has strong expectations for its biosimilars business, although it continues to represent a small portion of its overall revenues. Total first-quarter revenues for Biogen were $3.5 billion, up 1% from the year-ago quarter.