Oncology

The researchers concluded that the efficacy, safety, immunogenicity, pharmacokinetics, and pharmacodynamics of PF-05280586 and the reference were similar at the conclusion of the study at week 26.

Earlier this week, Daiichi Sankyo announced that it has launched its biosimilar trastuzumab, trastuzumab BS, referencing Herceptin, in Japan.

The FDA has approved Celltrion and Teva’s rituximab biosimilar, Truxima (rituximab-abbs).

Sandoz announced today that the European Commission has granted a marketing authorization for its pegfilgrastim biosimilar, Ziextenzo, referencing Neulasta.

The European Commission has granted a marketing authorization to Cinfa Biotech and Mundipharma’s biosimilar pegfilgrastim, Pelmeg, for all indications of the reference product, Neulasta.

Bevacizumab, an anti–vascular endothelial growth factor treatment for which 1 biosimilar has been approved to date, has been shown to improve quality of life for patients with glioblastoma—and to delay disease progression—but has not prolonged patients’ overall survival. However, recent research suggests that using 4 older drugs together with bevacizumab could provide a more effective treatment protocol.

Some studies have found that granulocyte colony-stimulating factor (G-CSF) therapies are underused for the prophylaxis of febrile neutropenia (FN) in Europe, but the widespread availability of cheaper biosimilar options has led to increased use. A new study, published in BMC Cancer, sought to examine the use of the biosimilar filgrastim, Zarzio, in relationship to European Organisation for Research and Treatment of Cancer (EORTC) guidelines.

The researchers say that their data were consistent with the pharmacokinetic equivalence previously demonstrated in a single-dose PK study that included 202 healthy adult men in the United States and European Union, and thus add to the evidence of ABP-215 as a high-quality biosimilar to bevacizumab for use in Japan.

Among long-term responders, first-line bevacizumab-based therapy is more effective in patients with HER2-negative metastatic breast cancer (MBC) who were not previously treated with taxanes, a recent Spanish study suggests.

During this week’s International Society for Pharmacoeconomics and Outcomes Research 2018 European meeting, the role of biosimilars in oncology is the subject of several research presentations, all of which underscore the importance of these agents in increasing patient access and driving down costs.

During the Community Oncology Alliance Payer Summit, held October 29-30, 2018, The Center for Biosimilars® had the opportunity to sit down with several oncologists to discuss their opinions on and experiences with biosimilars.

In its investor call on Thursday, Coherus Biosciences revealed that it will launch its biosimilar pegfilgrastim, Udenyca, at a 33% discount to the reference Neulasta.

While US patients with HER2-positive cancers do not have an available subcutaneous trastuzumab option, Brazil, Canada, and the European Union have an approved product that has been shown in a phase 3 trial to be noninferior to intravenous trastuzumab.

Given the high burden of cancer in the senior population, and given the increasingly high cost of cancer care, there is a growing interest in value-based oncology care payment models, particularly within CMS.

A recent study presented at the Annual Scientific Meeting of the British Blood Transfusion Society, held in Brighton, United Kingdom from October 3-5, 2018, sought to determine the impact of introducing biosimilar filgrastim (sold in the United Kingdom as Zarzio) on the number of patients who were able to achieve target CD34 yield in peripheral blood stem cell mobilization (PBCM).

Pegfilgrastim, a long-acting granulocyte-colony stimulating factor (G-CSF) therapy, has become a key product for the prophylaxis and treatment of febrile neutropenia, and biosimilar options have the potential to reduce the high cost of pegfilgrastim therapy. At the European Society for Medical Oncology 2018 Congress, held October 19-23, 2018, in Munich, Germany, 2 research teams presented on studies assessing proposed pegfilgrastim biosimilar products.

Anemia is a common complication for patients who are undergoing chemotherapy, and one that has implications for patients’ quality of life, especially with respect to fatigue. During the European Society for Medical Oncology 2018 Congress, held October 19-23, 2018, in Munich, Germany, Jérôme Desrame, MD, reported on results of the CIROCO study, which assessed fatigue in patients with chemotherapy-induced anemia who were treated with biosimilar epoetin alfa.

The European Society for Medical Oncology (ESMO) 2018 Congress, held October 19-23, 2018, in Munich, Germany, featured multiple presentations on biosimilars in oncology, all of which are contributing to the body of evidence that points to the safety and efficacy of these products. Despite such reassuring data for biosimilars, however, many stakeholders have noted that lack of provider education on biosimilars is holding back progress with uptake.

China-based drug maker Innovent Biologics has revealed that China’s National Medical Products Administration has approved its application to test a combination therapy comprising a proposed biosimilar bevacizumab product, IBI305, plus sintilimab, an anti–programmed cell death protein 1 (PD-1) monoclonal antibody.

A recent study provides insight into the feasibility of at-home administration of biosimilar filgrastim—Pfizer’s recently approved Nivestym—an option that has the potential to reduce patient burden associated with hospital administration.

In a vote on whether the totality of the evidence supported the licensure of CT-P10 as a biosimilar to Rituxan, all 16 Oncologic Drug Advisory Committee (ODAC) members voted yes, for reasons some enumerated as “overwhelming biosimilarity and clinical trial evidence” that “really sealed the deal.”

The Association of European Cancer Leagues, a nonprofit, pan-European organization of national and regional cancer societies, has issued a new white paper that calls for greater biosimilar use as a means to reduce costs and increase patient access to cancer treatment.

The FDA's Oncologic Drugs Advisory Committee (ODAC) briefing documents state that the totality of the evidence suggests that the proposed biosimilar is highly similar to its US-licensed reference, despite minor differences in clinically inactive compounds.

Pfizer indicated that Nivestym will be priced at a wholesale acquisition cost (WAC) of $350.40 per 480-mcg prefilled syringe, a WAC that is 30.3% lower than that of the reference Neupogen.

Health Canada has approved a formulation of Roche’s originator trastuzumab, Herceptin, that is intended for subcutaneous administration. The drug, indicated to treat HER2-positive cancers, can be administered in 2 to 5 minutes (versus an average of 90 minutes for intravenous administration).

The product is the first pegfilgrastim biosimilar to be authorized by the European Commission and the first Coherus product to be cleared by a regulatory authority.

Notably, the study was conducted in patients with cancer, rather than in a healthy population, to generate evidence of pharmacokinetic (PK) equivalence in a scenario that reflects how the biosimilar would be used in clinical practice.

A recently published study between the biosimilar and the reference rituximab, MabThera, demonstrated that the biosimilar was noninferior to the reference in terms of both efficacy and safety in treating chronic lymphocytic leukemia (CLL).

Today, Sandoz, Cinfa Biotech, and Mylan all revealed that they have received positive recommendations from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for proposed pegfilgrastim biosimilars referencing Neulasta.

Cetuximab (Erbitux), an anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody used in the treatment of head and neck and colorectal cancer, so far faces no biosimilar challengers. However, Chinese researchers are reporting positive preclinical results for a proposed biosimilar, APZ001.