FDA News

Gottlieb decries 'anti-competitive practices' delaying biosimilar testing

December 11, 2018
FDA Commissioner Scott Gottlieb, MD, on Tuesday announced a series of guidance documents aimed at expanding the availability of biosimilar drugs…
In the Journals

Infliximab biosimilar safe, effective for Crohn’s disease

December 10, 2018
The biosimilar of infliximab, CT-P13, demonstrated equivalency in safety and efficacy for the treatment of Crohn’s disease, according to data…
In the JournalsPerspective

Outcomes after switching to Enbrel biosimilar influenced by patient-related factors

December 4, 2018
Adjusted treatment retention rates after 1 year were lower among patients who switched from etanercept to a biosimilar compared with the historic…
FDA News

FDA approves Truxima, first biosimilar for adults with non-Hodgkin lymphoma

November 28, 2018
The FDA today approved rituximab-abbs as a single agent or in combination with chemotherapy for the treatment of adults with CD20-positive, B-cell…
FDA News

FDA approves Hyrimoz, third Humira biosimilar

October 31, 2018
The FDA has approved the third biosimilar to adalimumab, adalimumab-adaz, for all eligible indications of the biologic product, according to a…
FDA News

FDA panel unanimously backs Rituxan biosimilar for lymphoma

October 10, 2018
The FDA’s Oncologic Drugs Advisory Committee voted 16-0 to support the licensure of CT-P10 as a rituximab biosimilar for three non-Hodgkin…
FDA News

FDA accepts BLA for Samsung Bioepis' Humira biosimilar

September 27, 2018
The FDA has accepted for review a Biologics License Application from Samsung Bioepis for its Humira biosimilar, according to a company press release…
In the Journals Plus

Filgrastim biosimilars show ‘substantial uptake’ among Medicare beneficiaries

September 4, 2018
The use of biosimilar biologics filgrastim-sndz and tbo-filgrastim increased substantially among Medicare beneficiaries between 2014 and 2016…
In the JournalsPerspective

Infliximab biosimilar 'only moderately' less costly vs. biologic under Medicare Part D

September 4, 2018
Under Medicare Part D drug benefits, the biosimilar infliximab-dyyb was only 18% less expensive than the infliximab reference product, exceeding…
Meeting News

Education, patience key to guide biosimilar-hesitant patients through transition

August 11, 2018
FORT WORTH, Texas — Although the use of biosimilars is expected to improve patient access to biologics, open communication between providers…