Kelly Davio

April 09, 2019

In its announcement, the drug maker said that its Udenyca sales are expected to be in the range of $36 million to $38 million.

April 09, 2019

Genentech, together with City of Hope, has filed a new complaint for patent infringement against Pfizer over PF-06439535, Pfizer’s proposed bevacizumab biosimilar referencing Genentech’s Avastin.

April 08, 2019

This week, rheumatology experts will gather in Brisbane, Australia, for the 21st Congress of the Asia Pacific League of Associations for Rheumatology (APLAR) and Australian Rheumatology Association (ARA), held April 8-11. During the meeting, several groups of researchers will discuss real-world experience with biosimilar infliximab in Asia.

April 07, 2019

The study is an open-label extension of a phase 3 trial that included 68 weeks of treatment with the biosimilar adalimumab, Amjevita, followed by an assessment visit at week 70 and an end-of-study visit at week 72.

April 05, 2019

The FDA this week finalized a 2016 draft guidance that explains when the agency deems a Risk Evaluation and Mitigation Strategy (REMS) program to be necessary for a given drug.

April 04, 2019

Korean drug maker Celltrion announced that it has completed enrollment in its phase 3 clinical trial of CT-P17.

April 03, 2019

Fresenius Kabi announced today that it has received its first European marketing authorization for a biosimilar. The European Commission granted the drug developer approval for its adalimumab biosimilar, Idacio, for all indications of the reference product, Humira.

April 03, 2019

Sandoz announced today that it has resubmitted to the FDA its Biologics License Application (BLA) for its proposed biosimilar pegfilgrastim.

April 02, 2019

A new consensus report calls the nocebo effect underrecognized in the area of biosimilars and says that more research is needed on this important topic.

April 02, 2019

Yet another class action lawsuit has been filed against AbbVie, maker of the brand-name adalimumab, Humira. The latest suit, brought by the mayor and city council of Baltimore, Maryland, on behalf of themselves and others similarly situated, alleges that, absent AbbVie’s conduct, biosimilar adalimumab could have been available in the United States as early as 2016. It also alleges that biosimilar developer Amgen was paid by AbbVie to delay its marketing of a biosimilar adalimumab.