Oncology

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).

Hospitals classified as 340B institutions are playing an increasingly large role in oncology care, and the rapid growth in the federal 340B program has resulted in big changes in the oncology drug marketplace, according to a recent white paper released by the Community Oncology Alliance.

A Delaware Magistrate Judge has recommended that Amgen’s lawsuit against biosimilar developer Coherus be dismissed.

Roche has announced positive data on 2 of its innovator oncology biologics in combination with other therapies. The combinations using rituximab (MabThera, Rituxan) and bevacizumab (Avastin) could help the Swiss drug maker to protect sales of these monoclonal antibodies in the face of oncoming biosimilar competition.

Evaluate Group’s EP Vantage pharma and biotech preview of 2018 predicts that the uptick in the pharmaceutical and biotech sectors that occurred in 2017 is likely to continue into 2018.

Republic of Korea-based biopharma company Celltrion is looking to accelerate its momentum in Europe; analysts belive that the company could receive the European Medicines Agency’s (EMA) approval to market its biosimilar of Roche’s blockbuster cancer treatment, Herceptin (trastuzumab), by March 2018.

Our latest infographic provides 3 key takeaways from the American Society of Hematology's (ASH) 59th Annual Meeting and Exposition.

Results from a phase 1 clinical trial show that Sandoz’s proposed pegfilgrastim biosimilar (LA-EP2006) matched the reference biologic, Amgen’s Neulasta, in terms of safety, pharmacokinetics, pharmacodynamics, and immunogenicity in healthy subjects.

Advances in research have led to increased therapeutic options for patients with cancer, but these drugs come at a substantial cost; high out-of-pocket costs pose a significant barrier to treatment initiation for patients with cancer, according to a new, retrospective claims-based study.

USV has announced that the European Medicines Agency (EMA) has accepted for review its application for a proposed pegfilgrastim biosimilar.

Kashyap Patel, MD, medical oncologist at Carolina Blood and Cancer Care, discusses the value that biosimilars bring to the health system.

A recent study found that Cinfa Biotech’s proposed pegfilgrastim biosimilar, B12019, has similar pharmacodynamics (PD) and immunogenicity to the reference Neulasta.

A newly published study finds that subcutaneous administration of trastuzumab produces substantial time savings for healthcare providers and patients, as well as reduced costs.

Patients can be switched from reference rituximab (MabThera) to biosimilar rituximab (Truxima) without reverting to slower infusion rates, according to a new study.

A new study, conducted by Linglong Zou, PhD, and colleagues, evaluates the immunogenicity of tbo-filgrastim in patients receiving chemotherapy for solid and hematologic malignancies.

At the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Sanjeeev Balu, PhD, will present results of a study that examines expanded access to the drug obinutuzumab (Gazyva) made possible on a budget-neutral basis through savings obtained from using biosimilar filgrastim-sndz (Zarxio).

Since Novex’s commercial launch, the first national pharmacovigilance plan for a biosimilar monoclonal antibody has been implemented, and data from this post-marketing surveillance show that, in terms of tolerability, this biosimilar has a similar safety profile to that of the reference product.