Biosimilars Oncology Roundup: September 2022

In addition to our month-long series preparing for the 2023 introduction of adalimumab biosimilars, September featured a number of updates for oncology biosimilars, including 2 FDA approvals and the withdrawal of a European application.

FDA Approvals

At the beginning of the month, the FDA approved Fresenius Kabi’s pegfilgrastim biosimilar referencing Neulasta, Stimufend (pegfilgrastim-fpgk). The approval marked the sixth pegfilgrastim biosimilar to be approved in the United States. When launched, Stimufend will be used to treat patients with cancer undergoing chemotherapy who are at a high risk of febrile neutropenia

Towards the end of the month, the FDA approved another oncology biosimilar, Celltrion Healthcare’s Vegzelma, which references Avastin (bevacizumab). It is the fourth bevacizumab biosimilar to receive FDA approval and will be used to treat several types of cancer.

Company Updates

In addition to the FDA approvals, the United Kingdom’s Medicines and Healthcare Products Regulatory Agency also approved Vegzelma. The approval marked the third oncology biosimilar developed by Celltrion to be approved by the regulator, and the news came less than a month after the European Commission granted Vegzelma marketing authorization.

However, Prestige Biopharma withdrew its marketing authorization application for its trastuzumab biosimilar (Tuznue) that it submitted to the European Medicines Agency. The company cited the negative opinion from the Committee for Medicinal Products for Human Use and the results of its re-examination period as reasons and said that it plans to submit a new application at the end of 2022.

The Center for Biosimilars® interviewed Paul Reider, chief commercial officer at Coherus Biosciences, about its current pegfilgrastim biosimilar (Udenyca) and its soon-to-be marketed products (Cyltezo, adalimumab biosimilar; Cimerli, ranibizumab biosimilar). During the interview, Reider previewed the upcoming filing and potential launch of Coherus’ on-body pegfilgrastim biosimilar that will rival Neulasta Onpro.

Industry Analyses

Speakers at the DIA Biosimilars Conference concluded that better consensus across regulatory agencies regarding biosimilar policies could help promote biosimilar uptake. The speakers pointed out the definition discrepancies and concerns about evidence that switching between reference products and biosimilars is safe for patients and offered suggestions for what agencies could do to instill confidence in biosimilars.

A review article found that analytical and in-vitro functional studies along with pharmacokinetic and pharmacodynamic evaluation studies may not be useful for evaluating the efficacy of biosimilars. The review provided recommendations for the World Health Organization (WHO) Expert Committee on Biological Standardization in preparation for its planned revision of WHO guidelines.

The authors of the review called for the new guidelines to clarify quality measurements, establish a stepwise progression to reduce the need for in vivo nonclinical tests, and reduce the requirement for confirmatory efficacy and safety studies.

A column from Ivo Abraham, PhD, dove into how drug prices resulting from biosimilar competition has changed since the introduction of filgrastim biosimilars and factors that could contribute the most to price erosion. Abraham chronicled the pricing trends associated with the introduction of biosimilars for Neulasta, Neupogen (filgrastim), Rituxan (rituximab), Herceptin (trastuzumab), and Avastin.