Kelly Davio

October 11, 2019

The Institute for Clinical and Economic Review (ICER), a nonprofit health technology assessment body, has issued an updated report on treatments for rheumatoid arthritis (RA) in which it says that the Janus kinase (JAK) inhibitor upadacitinib has a marginal clinical benefit over adalimumab and an "incremental cost-utility ratio falling below commonly cited thresholds.”

October 11, 2019

The International Society of Oncology Pharmacy Practitioners (ISOPP), which convened in London, United Kingdom, this week for its 18th international symposium on oncology pharmacy practice, has issued a new global position statement on biosimilars in therapeutic and supportive oncology.

October 10, 2019

A new KPMG report, commissioned by generic and biosimilar trade group Medicines for Europe, identifies some of the features of drug procurement in hospitals in different countries in Europe, explains how they impact biosimilar uptake, and gives recommendations to help biosimilars play a role in the strong—and growing—need to reduce spending in health systems.

October 09, 2019

In treating patients with moderate to severe psoriasis, Samsung Bioepis’ etanercept biosimilar, approved in the European Union as Benepali and in the United States as Eticovo, was shown to be effective in a registry study.

October 09, 2019

The Institute for Clinical and Economic Review (ICER) has issued its first annual report on unsupported price increases for US drugs. The report found that 3 brand-name biologics that have FDA-approved biosimilars—adalimumab, rituximab, and pegfilgrastim—have had significant price increases that were not supported by new clinical evidence.

October 08, 2019

Even as biosimilars of anti–vascular endothelial growth factor (anti-VEGF) agents are coming to market and advancing through the pipeline, a new agent that may have substantial benefits for patients with wet age-related macular degeneration (AMD) has been approved by the FDA: brolucizumab, which sponsor Novartis will sell as Beovu.

October 08, 2019

The FDA has issued a complete response letter for Tanvex BioPharma’s TX01, a proposed biosimilar filgrastim referencing Neupogen.

October 07, 2019

According to the authors, while many anticipated that most major concerns about the switch to biosimilar adalimumab would relate to safety and efficacy, more prevalent concerns were related to device type, the presence of a citrate, or the color of the product.

October 07, 2019

The FDA has approved Pfenex’s follow-on teriparatide, PF708, referencing Forteo, for the treatment of osteoporosis in patients at high risk for fractures.

October 05, 2019

The Labour party, the United Kingdom’s official opposition party, revealed during a conference that it plans to reduce the cost of drugs by setting up a government-owned generic drug manufacturer that would supply medicine to the National Health Service and by employing compulsory licensing to use drug makers’ intellectual property to develop generics.