Kelly Davio

March 30, 2018

March 2018 saw a variety of developments for biosimilars in cancer care, both in the United States and abroad.

March 29, 2018

Eflapegrastim is novel long-acting granulocyte-colony stimulating factor therapy. Pharmacokinetic analysis in vivo demonstrated a 2- to 3-fold increase in area under the time‐concentration curve for absolute neutrophil count versus pegfilgrastim when administered at similar doses, and the proposed drug demonstrated comparable efficacy compared with pegfilgrastim in an open-label study in patients with breast cancer who were receiving docetaxel and cyclophosphamide.

March 29, 2018

FDA Commissioner Scott Gottlieb, MD, indicated that the agency would be putting forward policies that would compel branded drug makers to “tighten up their manufacturing, to have less variance of their biologics that are currently on the market.” In theory, this change could make it easier to develop a biosimilar using smaller studies.

March 28, 2018

A new brief from Avalere Health argues that, if a multisource market for biologic drugs is to emerge in the United States, originator biologics and biosimilars must be able to gain market share commensurate to the value they offer to the healthcare system, and a variety of policy options are available to create the necessary conditions for true competition.

March 28, 2018

The biosimilar insulin will be sold under the brand name Semglee in a 100 IU/mL 3mL prefilled pen presentation in both territories. Mylan and Biocon say that they plans to launch the product in various markets in Europe in the second half of 2018, and in Australia “later this year.”

March 27, 2018

Within the juvenile idiopathic arthritis subset, “patients had an extremely favorable probability of being neoplasm-free 5 years after initiation of biologics.”

March 27, 2018

While biosimilars have made significant inroads into the European marketplace, there remain hurdles to the adoption of these lower-cost drugs, especially in lower-income nations; external reference pricing can mean that drugs are priced to wealthier European countries’ financial capabilities, and manufacturers’ launch strategies may bring biosimilars to nations with the greatest market potential first.

March 26, 2018

During a symposium held during the 23rd annual conference of the National Comprehensive Cancer Network (NCCN), held last week in Orlando, Florida, Andrew D. Zelenetz, MD, PhD, of Memorial Sloan Kettering Cancer Center; Jeffrey Crawford, MD, of Duke University; and Lee Schwartzberg, MD, FACP, of University of Tennessee Health Science Center, presented on the use of biosimilars in oncology.

March 22, 2018

More than 90% of Indian patients with diffuse large B-cell lymphoma (DLBCL) treated from 2014 to 2015 had access to rituximab due to the biosimilar’s availability.

March 21, 2018

Although corticosteroids are a mainstay of treatment for immune reconstitution inflammatory syndrome (IRIS), some patients with HIV are refractory to corticosteroid therapy. Infliximab may be useful in treating IRIS, but little is known about patients who are also refractory to infliximab therapy.