EMA recommends approval of Humira biosimilar Imraldi

June 23, 2017
The European Medicines Agency has recommended the approval of the Imraldi, making it the third anti-TNF biosimilar candidate to receive a positive…

Supreme Court ruling accelerates availability of biosimilars

June 12, 2017
The Supreme Court issued a unanimous ruling today that will accelerate the pace at which biosimilars can be made available to the public. The court…
FDA News

FDA rejects Coherus application for proposed biosimilar to Neulasta

June 12, 2017
The FDA denied approval of Coherus BioSciences’ biologics license application for CHS-1701, a proposed biosimilar for pegfilgrastim. Like…

Biosimilar interchangeability: What it means for clinicians

May 8, 2017
The FDA in January released its draft guidance for a biosimilar to achieve the interchangeability designation.
FDA NewsPerspective

FDA issues draft guidance on biosimilar interchangeability

January 18, 2017
The FDA has released a draft guidance for industry outlining criteria for demonstrating that a biosimilar is interchangeable with a reference product…

Johnson & Johnson announces ruling related to its infliximab biosimilar

August 23, 2016
Johnson & Johnson announced the District of Massachusetts Federal Court issued a ruling on the summary judgment motion filed by Celltrion…

Biosimilars seen as safe, effective compared with reference biologics

August 1, 2016
Recently published results showed biosimilars used to treat rheumatoid arthritis, inflammatory bowel disease and psoriasis are as safe and effective…

Amgen, Daiichi Sankyo announce exclusive agreement to commercialize biosimilars in Japan

July 14, 2016
Amgen and Daiichi Sankyo Company Limited have announced their exclusive agreement to commercial nine biosimilars in Japan, according to a press…
FDA NewsPerspective

FDA advisory committee unanimously recommends approval of biosimilar to Enbrel

July 13, 2016
The FDA Arthritis Advisory Committee voted 20-0 in favor of recommending the approval of GP2015, Sandoz’s proposed biosimilar to Amgen’s…

Sandoz plans to launch five major global biosimilars by 2020

June 23, 2016
Sandoz, a Novartis company, announced plans to launch five major oncology and immunology biologic biosimilars by 2020, according to a recent press…
Healio Jobs