Biosimilar Oncology Roundup: September

September was a busy month for oncology biosimilars: the first anticancer biosimilar was approved in the US, new data showed promising momentum for additional therapies, and patent litigation yielded costly results for one biosimilar developer.

FDA Approves Bevacizumab Biosimilar, CHMP Recommends Trastuzumab

On September 14, the FDA approved Amgen and Allergan’s bevacizumab biosimilar, ABP 215 (Mvasi). The drug is not only the first biosimilar of the reference Avastin, but also the first anticancer biosimilar to gain FDA approval. The groundbreaking regulatory decision was hailed by FDA Commissioner Scott Gottlieb, MD, who said that the approval of such treatments is an “important way to help spur competition that can lower healthcare costs and increase access to important therapies.”

Bevacizumab was also the subject of a newly published study in Health and Quality of Life Outcomes. The study demonstrated that bevacizumab-containing regimens were associated with longer progression-free survival and overall survival (OS) than were non-bevacizumab regimens in newly diagnosed patients with non-squamous non—small cell lung cancer in real-world community oncology settings.

While US patients await news of a launch date for Mvasi, the European Union moved closer to the availability of another anticancer biosimilar, trastuzumab. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on Samsung Bioepis’ SB3, referenced on Herceptin. The European Commission will make a final decision on the drug, which Samsung Bioepis plans to market under the name Ontruzant.

Abstracts Presented at ESMO Show the Promise and Value of Oncology Biosimilars

Poster presentations at the European Society for Medical Oncology’s (ESMO) 2017 Congress in Madrid, Spain (September 8 to September 12) included the results of 5 studies on biosimilar trastuzumab candidates:

• A study of Amgen’s ABP 980 showed that the biosimilar had clinical equivalence to the reference trastuzumab in the neoadjuvant setting in patient with HER2-positive early breast cancer (EBC).
• Celltrion’s CT-P6 was the subject of a phase 3 study that showed equivalent efficacy of the biosimilar with its reference in HER2-positive EBC, and also showed that the biosimilar was well tolerated.
• One-year safety, immunogenicity, and survival results for Samsung Bioepis’ SB3 supported biosimilarity between the biosimilar and the reference.
• A comparative clinical trial of Pfizer’s PF-05280014 demonstrated similarity in efficacy, safety, and immunogenicity—and also demonstrated noninferiority in terms of pharmacokinetics (PK)—with the reference.
• Another study on Pfizer’s drug, a randomized, double-blind efficacy and safety study, showed similar efficacy, safety, immunogenicity, and PK between the biosimilar and the reference.

Biosimilars of filgrastim and pegfilgrastim were also the subjects of 3 ESMO poster presentations:

• A literature review on filgrastim in oncology practice demonstrated that, while health technology assessments once suggested a low value for filgrastim because of its high initial cost and lack of early evidence concerning significant gains in OS, more recent meta-analyses show falling costs due to biosimilar competition and gains in OS.
• Cinfa Biotech’s pegfilgrastim biosimilar, B12019, demonstrated PK and pharmacodynamic (PD) comparability with the reference Neulasta in 2 highly sensitive clinical study settings.
• Gedeon Richter’s proposed pegfilgrastim biosimilar, RGB-02, was demonstrated to have therapeutic equivalence and a similar safety profile to the reference in a randomized, comparative, double-blind, multicenter study.

Patent Disputes Yield Costly Outcomes

A federal jury found that Hospira infringed on a patent owned by Amgen for its epoetin alfa, Epogen. Hospira, which has received a Complete Response Letter from the FDA for its proposed biosimilar, argued, unsuccessfully, that its development of a biosimilar pegfilgrastim was protected under safe harbor. The court ordered Hospira to pay Amgen $70 million.

Meanwhile, Amgen also filed new Biologics Price Competition and Innovation Act litigation against another biosimilar developer this week; the Neulasta maker contends that Mylan infringed on 2 of its US patents when it developed a biosimilar candidate that is currently under review by the FDA. Amgen seeks an order enjoining Mylan, which expects a regulatory decision on its biosimilar candidate by its Biosimilar User Fee Act date of October 9, from infringing on the patents, which cover processes for and methods of purifying proteins.