Kelly Davio

February 23, 2018

In an animal model of bleomycin-induced lung toxicity, filgrastim increased alveolar neutrophil recruitment, pulmonary edema, and lung myeloperoxidase activity. That finding led to concerns about whether filgrastim could increase pulmonary toxicity when used together with adriamycin, bleomycin, vinblastine, and dacarbazine regimens.

February 22, 2018

The international initiative AllTrials has launched a new online tracking tool that publicly discloses which research entities have not reported data from clinical trials.

February 21, 2018

The Patients for Biologics Safety and Access (PBSA) is calling on the FDA to revise its prescriber-directed online educational materials on biosimilars. However, not all patient groups agree with PBSA’s stance.

February 20, 2018

Last week, at the European Crohn's and Colitis Organisation's 13th annual congress in Vienna, Austria, researchers presented data from the NOR-SWITCH EXTENSION trial—a 26-week open label extension of the NOR-SWITCH trial—concerning the inflammatory bowel disease (IBD) subgroup.

February 19, 2018

At the European Crohn’s and Colitis Organisation’s 13th annual congress, held in Vienna, Austria, a number of studies explored switching from reference infliximab to its biosimilar.

February 17, 2018

Today, at the 13th Congress of the European Crohn’s and Colitis Organisation (ECCO), researchers released 12-month data from the Personalized Anti–Tumor Necrosis Factor (anti-TNF) Therapy in Crohn Disease (CD) Study (PANTS).

February 16, 2018

This week, the American Society of Clinical Oncology (ASCO) released a new statement that seeks to offer clinicians guidance on the use of biosimilars in oncology as a wave of patent expirations is expected to bring more anti-cancer and supportive care biosimilars to the US market.

February 15, 2018

A study recently published in the European Journal of Hematology reports diffuse large B-cell lymphoma (DLBCL)–specific findings from MONITOR-GCSF, a pan-European, multicenter, prospective, observational study that attempts to describe the treatment patterns and clinical outcomes of patients who received biosimilar filgrastim in the prophylaxis of chemotherapy-induced neutropenia and febrile neutropenia.

February 14, 2018

According to Roy Fleischmann, MD, a recent American College of Rheumatology (ACR) white paper appropriately describes issues including the nomenclature of biosimilars, the biosimilar approval pathway, and differences between biosimilars for biologic drugs and generics for small-molecule drugs. However, he takes issue with ACR's stance on substitution, extrapolation, and interchangeability.

February 14, 2018

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.