Oncology

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.

Bevacizumab is employed cautiously in patients with multifocal glioblastomas rather than single glioblastomas because of a fear, based on unconfirmed preclinical data, that bevacizumab can increase the invasive tumor phenotype.

In clinical practice, biologics are routinely used for medically accepted off-label indications, and these uses are typically curated by guidelines. A newly published study, led by Edward Li, PharmD, MPH, BCOP, argues that the FDA’s framework for granting the extrapolation of indications for biosimilars can be used by clinicians and payers to determine appropriate off-label uses of biosimilars.

2017 brought a number of notable guests to The Center for Biosimilars®. Here are the most-watched interviews of the year.

Republic of Korea-based Samsung Bioepis announced on Tuesday that the FDA has accepted for review the company’s Biologics License Application (BLA) for SB3, a proposed trastuzumab biosimilar, referenced on Herceptin. If the FDA approves SB3, the drug will be commercialized in the US by Merck.

Jeff Patton, MD, president and CEO of Tennessee Oncology, discusses how biosimilars fit into the Oncology Care Model (OCM).