Oncology

The FDA has approved Fujifilm Kyowa Kirin Biologics's Hulio adalimumab biosimilar, making it the sixth adalimumab biosimilar approved in the United States. However, none will be launched before 2023 because of the strength of AbbVie's exclusivity rights for Humira, the reference product. Hulio launched in Europe in 2018.

Biocon is planning to list its biosimilar entity, Biocon Biologics, on the capital markets in the next few years. Although this move will allow the entity to expand on current projects, it also raises questions about whether it will be successful.

Genentech seeks to block the marketing of Samsung Bioepis’ proposed bevacizumab biosimilar, saying the company infringed multiple patents when submitting an FDA approval application.

Slow growth of use of biosimilar infliximab in a Medicare fee-for-service population suggests lingering hesitancy on the part of gastroenterologists and patients, particularly when it comes to extrapolation to off-label uses, according to a new study.

A review laid out ways for nurses to address patients’ questions on biosimilars in order to help them take on the role of improving utilization rates in cancer treatment.

Wayne Winegarden, PhD, director of the Center for Medical Economics and Innovation, explains that misaligned incentives are preventing the United States from realizing full benefit from biosimilars.

In upholding a lower court ruling, a federal circuit court has decided that Amgen gave enough notice prior to launching its bevacizumab biosimilar. The court decision has frustrated an attempt by Genentech to block sales of the product.

After a study from India suggested a higher incidence of adverse reactions in patients using biosimilar filgrastims, 2 European biosimilar consultants and oncologists raised objections to the study’s methodology.

A phase 3 clinical trial comparing the safety, efficacy, and immunogenicity of Samsung Bioepis’ aflibercept biosimilar with reference Eylea is now underway.

A new scorecard system developed by IQVIA rates the health and sustainability of biosimilars markets across Europe.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended Samsung Bioepis’ bevacizumab biosimilar for the treatment of multiple types of cancer.

Investigators found that manufacturers appear to be exploiting orphan drug exclusivities to extend market dominance and keep generics and biosimilars at bay.

China’s National Medical Products Administration (NMPA) has accepted an application for a biosimilar bevacizumab developed by Bio-Thera Solutions for treatment of certain lung and colorectal cancers.

Innovent Biologics said China’s National Medical Products Administration (NMPA) has approved its biosimilar bevacizumab, Byvasda, for use in patients with lung and colorectal cancers.

HLX04, a bevacizumab biosimilar candidate targeted at the colorectal and non–small cell lung cancer markets, met a phase 3 study primary end point, Shanghai Henlius Biotech said.

Here is a summary of our coverage from EHA25 Virtual, the annual meeting for the European Hematology Association (EHA).

A rituximab biosimilar developed by Celltrion Healthcare demonstrates safety and efficacy in patients with relapsed or refractory aggressive B-cell lymphoma, in findings presented at EHA25 Virtual, the annual meeting of the European Hematology Association.

Investigators reported an 88% overall response rate for a Sandoz rituximab biosimilar in combination with chemotherapy in patients with CD20-positive diffuse large B-cell lymphoma.

The FDA has approved Pfizer’s pegfilgrastim biosimilar Nyvepria for use in lowering the incidence of infection as manifested by febrile neutropenia.

Investigators produced what they described as the first evidence supporting the use of biosimilar erythropoiesis-stimulating agents (ESAs) in patients with myelofibrosis-related anemia.

Canada Health has approved the launch of Sandoz' pegfilgrastim and rituximab biosimilars.

Biosimilar discounts to reference products have improved over time, but they are deeper in some categories than others.

As part of pilot program designed to improve access to cheaper medications in oncology, a rituximab biosimilar from Celltrion has been approved for use by the World Health Organization (WHO).

Recognizing that oncology practices are struggling with the pandemic, the Center for Medicare and Medicaid Innovation has eased some performance requirements.

Here is a summary of our coverage from ASCO20 Virtual, the annual meeting for the American Society of Clinical Oncology (ASCO).

Clinical trials leading up to biosimilar approval may not reveal the full safety and efficacy profile of biosimilars vs reference products, and postmarketing studies may be essential to elucidate any differences, investigators said.

A real-world study helped show how pegfilgrastim biosimilar can improve savings in the Oncology Care Model and its successor, the Oncology Care First Model, according to findings presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology.

Switching patients with cancer to biosimilar pegfilgrastim for prophylaxis treatment of chemotherapy-induced febrile neutropenia could generate significant savings for adjuvant treatment, investigators found in studies presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology (ASCO).

Shanghai Henlius Biotech received a positive European review opinion for its trastuzumab biosimilar HLXO2 and anticipates marketing authorization in 2 to 3 months.

When used as a primary prophylaxis, biosimilar filgrastim (Zarxio) was found to be cost-effective when used to treat patients with nonmetastatic non–small cell lung cancer (NSCLC), according to a study presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology (ASCO).