Kelly Davio

June 17, 2019

A new study has found that switching among multiple biosimilar infliximab products was not associated with increased immunogenicity in patients with inflammatory diseases.

June 14, 2019

During this week’s European League Against Rheumatism Annual European Congress of Rheumatology, researchers will present on the long-term safety, immunogenicity, and efficacy of the biosimilar versus the reference in an open-label extension study that involved switching between the biosimilar and the reference.

June 13, 2019

During this week’s European League Against Rheumatism European Congress of Rheumatology 2019, 2 research teams will present their contrasting findings on education and the nocebo effect.

June 12, 2019

During this week’s European League Against Rheumatism (EULAR) Annual European Congress of Rheumatology, multiple teams of researchers will present their findings on real-world evidence of the biosimilar’s efficacy and the feasibility of switching to SB4 from the reference etanercept, Enbrel.

June 11, 2019

This month, a research letter appearing in JAMA Internal Medicine raises the questions of whether regulatory filings for new products are already made publicly available despite the FDA’s stance of treating these applications as confidential and whether there is room for increased transparency from the agency.

June 10, 2019

“This systematic literature review found that the overall economic impact of biosimilar [nonmedical switching] remains uncertain,” write the investigators. More real-world studies will be necessary, they indicate, to quantify the full economic impact of nonmedical switches over the short and long term.

June 10, 2019

Insulin maker Sanofi is currently developing a proposed biosimilar of insulin aspart (NovoLog), made by Novo Nordisk. In 3 late-breaking poster presentations at the American Diabetes Association (ADA) 79th Scientific Sessions, held June 7-11, 2019, in San Francisco, California, researchers presented data on the biosimilar, SAR341402.

June 08, 2019

Pfenex and its partner Alvogen have submitted to the European Medicines Agency (EMA) a Marketing Authorization Application for PF708, which is a proposed biosimilar of teriparatide (Forteo), an osteoporosis drug.

June 07, 2019

Early treatment with a biosimilar agent increased total costs by £70 (US $89) per patient versus standard intervention.

June 06, 2019

During this week’s 2019 American Society of Clinical Oncology Annual Meeting, researchers reported on the cardiac safety of Amgen’s biosimilar trastuzumab, ABP 980 (approved in the European Union under the name Kanjinti), versus the reference trastuzumab, Herceptin.