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Boehringer Ingelheim's First Biosimilar Is Approved in Europe

Boehringer Ingelheim (BI) announced today that it received marketing authorization in Europe for Cyltezo®, which is a biosimilar to Humira®.  Cyltezo® was approved for the treatment of multiple chronic inflammatory diseases in adults and children.  As previously reported, BI’s Cyltezo® was approved by the FDA on August 25, 2017, and…

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Mylan Resubmits EMA Applications for Trastuzumab and Pegfilgrastim

As we previously reported, earlier this year Biocon requested withdrawal and re-submission of its Marketing Authorization Applications for its trastuzumab and pegfilgrastim biosimilars with the European Medicines Agency (EMA), as part of the EMA’s procedural requirements linked to the re-inspection of Biocon’s facility.  Today, Biocon’s partner Mylan re-submitted the applications…

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Updates on Sandoz's Pegfilgrastim Biosimilar / Amgen v. Sandoz

Today, Sandoz announced that its biosimilar of Neulasta® (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review.  According to the press release, the data package submitted as part of the Marketing Authorization Application “strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms of safety,…

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Brexit’s Impact on the Biosimilar Market

The United Kingdom’s referendum in favor of withdrawal from the European Union, colloquially known as “Brexit,” has already sent shockwaves through the business world, both within the UK, and abroad.  The impact of Brexit on the pharmaceutical industry has yet to be determined, but some fear that Brexit will cause…

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