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July 08, 2016
A Federal Circuit court ruled biosimilar makers must wait 180 days after receiving FDA approval before bringing drugs to market.
June 15, 2016
A study published in BMJ indicates that rheumatic patients with anti-infliximab antibodies may have a similar cross reaction to infliximab biosimilars.
June 10, 2016
Alvotech prepares for commercial biosimilar production in new facility with single-use bioreactors in Reykjavik, Iceland.
June 06, 2016
The agency reiterated its earlier decision to require suffixes in biosimilar naming, but was unclear on suffix meaning.
June 01, 2016
More efforts are needed to raise awareness of biosimilars among physicians and patients in Europe and address scepticisms about the quality and safety of biosimilars.
May 10, 2016
The GPhA and its Biosimilars Council expressed concern about the new proposed value-based reimbursement rules for Part B medications.
February 18, 2016
The course, intended for healthcare professionals, provides an overview of biosimilar products and FDA’s biosimilar product development programs.
February 09, 2016
There are no clinically meaningful differences between Celltrion’s CT-P13 and Remicade, according to an FDA briefing released ahead of the formal panel meeting.
February 01, 2016
The Biosimilars Forum launched Partnership for Biosimilars Education and Access, an education initiative raising awareness of biosimilars in the US.
January 28, 2016
NICE announces plans to back biosimilar alternatives to Merck’s Remicade.