Kelly Davio

July 08, 2019

Biosimilar developer Samsung Bioepis has gained an updated label for its biosimilar adalimumab, Imraldi, referencing Humira. The biosimilar is now approved for storage in nonrefrigerated conditions for up to 28 days. This update means that the biosimilar can now be stored for an additional 2 weeks at room temperature.

July 05, 2019

Anti–vascular endothelial growth factor therapy is the standard of care for the first-line treatment of macular edema associated with central retinal vein occlusion or hemiretinal vein occlusion, and a number of therapeutic options are available, including aflibercept, ranibizumab, and off-label bevacizumab.

July 05, 2019

The subcutaneously administered trastuzumab contains the same monoclonal antibody as the intravenous formulation at a dose of 600 mg per 5-mL vial, plus a recombinant human hyaluronidase, to be used every 3 weeks. The hyaluronidase is used to increase the permeability of the extracellular matrix, allowing for administration of higher volumes and enhanced absorption of the drug.

July 02, 2019

As more centers begin to switch patients from reference infliximab to biosimilar options, patients who have benefitted from rapid infusions of the reference product may want to continue to receive time-saving infusions that reduce the burden of lengthy visits to infusion centers.

July 02, 2019

Given the head-to-head data from the SPIRIT trial, Humira maker AbbVie may face even further challenges in trying to maintain its sales as newer products like ixekizumab advance in such therapeutic areas as psoriatic arthritis (PsA).

July 01, 2019

In a study conducted from 2017 to 2018 among all of the infliximab-treated patients with inflammatory bowel disease (IBD) in a single center, patients who were in clinical remission were invited to complete a questionnaire to assess their biosimilar knowledge and acceptance of a switch.

June 30, 2019

Starting in 2017, the Henry Ford Cancer Institute started using follow-on filgrastim (tbo-filgrastim, a product approved prior to the establishment of the biosimilar approval pathway in the United States) and biosimilar filgrastim (Zarxio) in stem cell mobilization prior to transplant.

June 28, 2019

June 2019 was a busy month for oncology biosimilars, in both the supportive care and anticancer contexts, with regulatory activity and the presentation of reassuring new data.

June 28, 2019

The FDA has approved Pfizer’s bevacizumab biosimilar, bevacizumab-bvzr, referencing Avastin.

June 27, 2019

The Biosimilars Council, a part of the Association for Accessible Medicines, has issued a new white paper in which it condemns abuses of the patent system that delay biosimilar competition. It also argues that legislative proposals to regulate settlements would “merely benefit companies investing in the creation of patent thickets.”