Kelly Davio

August 13, 2019

This month, researchers published data from a phase 3 study of the biosimilar in patients with moderate to severe rheumatoid arthritis (RA) after previous phase 3 data were reported for a study in patients with severe plaque psoriasis.

August 13, 2019

Instead of the “totality of the evidence” approach to biosimilars, authors of a new paper propose a “confirmation of sufficient likeness” paradigm.

August 12, 2019

The Canadian government has announced amendments to its regulations concerning patented drugs that it says will make medicines more affordable. According to Health Canada, these changes will save Canadians $13.2 billion (US $9.97 billion) over the next decade.

August 12, 2019

A judge for the United States District Court for the District of New Jersey has ruled in favor of Amgen in a long-running patent litigation concerning Sandoz’s biosimilar etanercept, Erelzi.

August 11, 2019

Among the patients who viewed positively framed video explanations of biosimilars, 67% were willing to switch.

August 09, 2019

A panel of judges for the United States Court of Appeals for the Federal Circuit has denied Genentech’s motion to block sales of Amgen’s biosimilar trastuzumab pending the outcome of an ongoing appeal.

August 08, 2019

OneOncology, a national partnership of community oncology practices, says that its partner practices have begun treating patients with 2 anticancer biosimilars: Kanjinti, a trastuzumab biosimilar referencing Herceptin, and Mvasi, a bevacizumab biosimilar referencing Avastin.

August 07, 2019

A study published this month proposes that biosimilars be assessed in a quantitative benefit-risk analysis to assess whether what the authors call “uncertainty in the clinical performance of biosimilars” can be countered by lower pricing.

August 06, 2019

Not everyone shares the view that authorized generics are a boon, and concerns are rising that the marketplace may soon see the advent of authorized biologics.

August 06, 2019

Samsung Bioepis’ etanercept biosimilar, SB4, has been available in multiple markets since it was authorized by the European Commission in 2016, and this week, a new systematic review reported on real-world evidence on the use of the biosimilar in treating inflammatory diseases.