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…
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…
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,…
The European Medicines Agency (EMA) and the European Commission have jointly released an informational guide on biosimilars for healthcare providers. The guide aims to inform healthcare providers about the benefits of biosimilars to their practices and patients. Professor Guido Rasi, Executive Director of the EMA, states the following in his Foreword:…
The European Medicines Agency (EMA) is planning to launch a pilot project aimed at testing the value of tailored scientific advice for the development of biosimilar medicines. Based on the analysis of analytical and functional data provided by the applicants, the EMA will provide recommendations on which tests/studies should be…
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…