Albert Bourla, DVM, PhD, Pfizer’s chief executive officer, announced during the company’s third quarter 2019 earnings call that Pfizer has set launch dates for its biosimilar rituximab, Ruxience (referencing Rituxan), and trastuzumab, Trazimera (referencing Herceptin).
Albert Bourla, DVM, PhD, Pfizer’s chief executive officer, announced during the company’s third quarter 2019 earnings call that Pfizer has set launch dates for its biosimilar rituximab, Ruxience (referencing Rituxan), and trastuzumab, Trazimera (referencing Herceptin).
According to Bourla, Ruxience will become commercially available in January 2020, and Trazimera will follow on February 15, 2020. The company previously confirmed that it plans to launch its biosimilar bevacizumab, Zirabev, on December 31, 2019.
Ruxience was approved in July of this year for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis. Trazimera was approved in March of this year for the treatment of HER2-positive breast cancer and metastatic gastric cancer. Zirabev was approved in June of this year for the treatment of metastatic colorectal cancer, non—small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, and cervical cancer.
During his comments, Bourla also noted that Pfizer’s efforts to encourage biosimilar-friendly policies and legislation are beginning to bear fruit. “None of our breakthroughs will do any good if patients cannot afford them,” said Bourla, adding that “our proposals regarding biosimilars have been well received,” and bipartisan legislation to promote biosimilars in the United States is advancing.
Bourla indicated that key objectives for Pfizer products in general include reducing patients’ out-of-pocket costs, and aggressively pursing value-based reimbursement that will link reimbursement with outcomes.
In terms of Pfizer’s existing biosimilars business, biosimilar infliximab, Inflectra, which treats inflammatory diseases, saw 8% growth in the United States over 2018, rising from $71 million to $77 million (unaudited). Worldwide, however, sales of the same product, sold as Remsima in other territories, were down by 7%, falling from $166 million in 2018 to $155 million (unaudited).
Biosimilar epoetin alfa, Retacrit, brought in $64 million worldwide, and $42 million in the United States.
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
February 6th 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.
Biosimilars Gastroenterology Roundup for November 2024—Podcast Edition
December 1st 2024On this episode of Not So Different, we discuss market changes in the adalimumab space; calls for PBM transparency and biosimilar access reforms grew; new data for biosimilars in gastroenterology conditions; and all the takeaways from this year's Global Biosimilars Week.
The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars
February 5th 2025Of the 118 biologics losing exclusivity over the next decade, only 10% have biosimilars in development, meaning a vast majority of biologics have no pipeline, which limits savings potential for the health care system.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
BioRationality: No More Biosimilars—Just Biogenerics
February 3rd 2025Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.