Kelly Davio

December 24, 2018

Drugs that treat rare diseases are granted various incentives under the Orphan Drug Act of 1983 if they meet criteria related to the size of the rare disease population (under 200,000 people) that can be effectively treated by the drug in question. The Government Accountability Office (GAO) recently issued a report that finds serious deficiencies with the ways in which the Orphan Drug Act is administered by the FDA.

December 21, 2018

During last month’s European Society for Medical Oncology Asia 2018 annual meeting, held in Singapore from November 23 to November 25, researchers presented data demonstrating the biosimilarity of QL1101 with reference bevacizumab (Avastin).

December 20, 2018

CreakyJoints, a patient organization that is part of the Global Healthy Living Foundation (GHLF), has released the first edition of its patient guide to biosimilar medicines.

December 20, 2018

Sandoz has entered into an agreement with Chinese drug maker Gan and Lee to commercialize biosimilar insulins to treat patients with type 1 and type 2 diabetes.

December 19, 2018

While many stakeholders are concerned most immediately about how a recent ruling on the Affordable Care Act (ACA) could affect US patients’ healthcare options and coverage for pre-existing conditions, the biosimilars industry is also concerned about the future of one key feature of the ACA that keenly impacts the biosimilars landscape: the Biologics Price Competition and Innovation Act.

December 18, 2018

Last week, Republicans in the House of Representatives and in the Senate introduced legislation that would restrict generic and biosimilar developers from challenging patents on reference drugs using the inter partes review (IPR) process.

December 17, 2018

On Friday, Pfizer announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion of its proposed bevacizumab biosimilar, PF-06439535, to be marketed under the trade name Zirabev.

December 16, 2018

The authors concluded that in their analysis of real-world data, the effectiveness of the biosimilar was equivalent to that of the reference product in patients with Crohn disease (CD) who were naïve to therapy with infliximab, and no difference was observed in terms of safety between the 2 therapies.

December 15, 2018

The FDA has approved Celltrion and Teva’s Herzuma (trastuzumab-pkrb), a biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive breast cancer.

December 13, 2018

Second-generation anti–tumor necrosis factor (TNF) agents, etanercept, certolizumab, and golimumab, demonstrated a stronger neutralizing effect toward TNF versus first-generation anti-TNF agents, infliximab and adalimumab.