Kelly Davio

December 06, 2017

The Association for Accessible Medicines (AAM), a trade association that represents biosimilar and generic drug makers, has filed an amicus brief in support of Mylan, Teva, and Akorn in their inter partes review (IPR) proceeding against Allergan, owner of embattled patents covering cyclosporine ophthalmic emulsion (Restasis).

December 05, 2017

On Sunday, December 10, at the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Noah Federman, MD, will present research from a phase 2 study on the use of subcutaneous tbo-filgrastim (Granix) in pediatric patients with solid tumors who are undergoing chemotherapy.

December 04, 2017

On Saturday, December 9, at the American Society of Hematology’s 59th Annual Meeting and Exposition in Atlanta, Georgia, Scott Huntington, MD, MPH, will present his research team’s findings that the receipt of lymphoma care in the community-based setting is associated with guideline-discordant use of rituximab.

December 02, 2017

Russian biosimilar developer Biocad has announced that it will begin manufacturing its rituximab and bevacizumab biosimilars in Morocco. The 2 drugs, manufactured in partnership with Sothema Labs, will be sold in numerous markets in North Africa, including Morocco, Senegal, Gabon, and Cote d’Ivoire.

December 01, 2017

The FDA has approved Mylan–Biocon’s trastuzumab biosimilar, MYL-1401O, referenced on Roche’s Herceptin. The drug will be marketed in the United States as Ogivri.

December 01, 2017

November saw a number of developments related to biosimilar therapies for rheumatologic indications, with new data published, policies adapted, and devices launched.

November 30, 2017

The European Commission (EC) has launched a patient-focused question-and-answer document, titled “What I Need to Know About Biosimilar Medicines,” in 23 EU languages.

November 28, 2017

Patients with ankylosing spondylitis (AS) may benefit from biologic therapies, including anti–tumor necrosis factor (anti-TNF) treatments including adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi), and infliximab (Remicade or its biosimiars, Inflectra and Renflexis).

November 27, 2017

Drug maker Biocon has launched a biosimilar bevacizumab (referenced on Avastin) in India.

November 22, 2017

A recent case report, published in the European Journal of Rheumatology, showed that switching to biosimilar infliximab resulted in a rapid loss of efficacy in 3 patients with Behçet’s disease (BD), a chronic, relapsing, systemic vasculitis.