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April 21, 2015
A presentation by Jim Miller will offer a detailed review of the contract services landscape.
April 02, 2015
In this article, industry experts discuss critical analyses for demonstrating biosimilarity.
FDA approves a biosimilar and loses a commissioner in March.
March 30, 2015
Biosimilar applicants will not be required to hand over their biosimilar applications and manufacturing dossiers to innovator companies, determines FDA.
March 13, 2015
BIO and the Colorado BioScience Association urge Colorado Governor Hickenlooper to sign a bill that will help patients gain access to interchangeable biologic products following FDA approvals.
March 06, 2015
In a landmark decision, FDA approved Zarxio, making it the first biosimilar product in the United States.
March 03, 2015
Biosimilars may add a nice increment to the pipeline opportunities, for CMOs, but they are unlikely to be a bonanza for the industry.
March 02, 2015
A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.
February 27, 2015
FDA announced that it would postpone a meeting that would be critical for the advancement of Celltrion’s Remicade biosimilar in the US.
February 25, 2015
Remsima will now be available for patients in 12 additional countries in the European Union.