Oncology

Celltrion’s head of strategy and operations, Ho Ung Kim, told reporters this week that the intravenous Herzuma could be launched at as much as a 50% discount to a subcutaneously administered presentation of the reference Herceptin.

Higher levels of cancer-related financial toxicity are associated with decreased quality of life, poorer treatment adherence, and poorer survival for adult patients with cancer.

The early weeks of 2018 held substantial developments for oncology biosimilars in the United States and around the world, with new products on the horizon and evolving challenges in bringing these drugs to the marketplace.

A study newly published in the Journal of Clinical Oncology found that SB3, a proposed trastuzumab biosimilar being developed by Samsung Bioepis, demonstrated equivalence with European-sourced reference trastuzumab (Herceptin) in terms of breast pathologic complete response (bpCR) rate. Safety and immunogenicity for the 2 drugs were also similar.

Zarxio, a biosimilar filgrastim approved in the United States in 2015, was demonstrated to have no clinically meaningful differences from its reference in a randomized clinical trial setting, but data on its effectiveness in preventing febrile neutropenia (FN) a real-world setting have been limited thus far.

Multiple drug makers are in the process of developing biosimilar candidates to challenge the brand-name Erbitux’s sales.

A study published yesterday in Cancer Chemotherapy and Pharmacology reports that pharmacokinetic (PK) and pharmacodynamic (PD) data from a randomized, double-blind, phase 3 clinical study show similarity between mAbxience’s proposed rituximab biosimilar, RTXM83, and its reference, MabThera, using a population PK model approach.

Pfizer announced today that PF-05280586, the company’s proposed biosimilar to reference rituximab (Rituxan, MabThera), has been shown to be equivalent to the reference in overall response rate for the first-line treatment of patients with CD20-positive, low tumor burden follicular lymphoma.

The Brazilian Society of Clinical Oncology has released its official position on the use of biosimilars in oncology. Thus far, only 2 oncology biosimilars (filgrastim and trastuzumab) have been approved for use in Brazil, though the number of applications filed with the National Health Surveillance Agency is expected to grow steadily in the coming years.

Amgen and Allergan announced on Thursday that the European Commission has granted a marketing authorization to Mvasi, a biosimilar bevacizumab referencing Avastin, for the treatment of certain cancers.

Researchers based in the Republic of Korea have published data suggesting that they were able to produce a promising biosimilar obinutuzumab candidate from the plant Nicotiana benthamiana L. that is equivalent to obinutuzumab produced in glyco-engineered Chinese hamster ovary cells.

Australian biosimilar developer NeuClone has announced that it is developing a proposed biosimilar denosumab (referenced on Amgen’s Prolia, Xgeva).

While the European experience with biosimilars is one of significant uptake of biosimilars, individual European nations have had distinctly different levels of uptake. These differences are largely due to local variation in pricing and reimbursement, education levels, population characteristics, and stakeholder incentives.