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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....
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Busy Week for Biosimilars Worldwide
United States: On July 13, an FDA advisory committee voted to recommend approval of Sandoz’s biosimilar to Enbrel® (etanercept). The recommendation was to approve the biosimilar for all indications...
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CHMP Recommends Approval of Three Biosimilars to EMA
The Committee for Medicinal Products for Human Use, (“CHMP”), the committee at the European Medicines Agency (“EMA”) that is responsible for preparing opinions on questions concerning medicines for...
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Amgen and Allergan Submit European Application for Avastin® Biosimilar
We recently reported that Amgen and Allergan had submitted an abbreviated Biologics License Application to the FDA for ABP 215, a biosimilar to Avastin® (bevacizumab). Today, the companies announced...
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Guidance on Biosimilar Submission Requirements in Canada
Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada recently released a revised Guidance Document on Information and Submission...
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Boehringer Ingelheim’s biosimilar candidate to Humira accepted for review by...
Boehringer Ingelheim today announced that its adalimumab biosimilar (biosimilar to Humira) has been accepted for regulatory review by the FDA and the EMA (European Medicines Agency). This is the second...
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Novartis and Sandoz Withdraw Zioxtenzo (pegfilgrastim) European Application
The EMA announced on January 27 that Novartis and Sandoz have withdrawn their marketing application for their pegfilgrastim biosimilar (Zioxtenzo). The application was withdrawn after the Committee...
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EMA Releases Informational Guide on Biosimilars for Healthcare Providers
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...
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BIOCON REQUESTS WITHDRAWAL AND RE-SUBMISSION OF EMA APPLICATIONS FOR ITS...
As we’ve posted here, Biocon and Mylan are jointly developing a portfolio of biosimilars, including Fulphila (Pegfilgrastim) and Ogivri (Trastuzumab), and have filed applications for marketing...
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IRELAND’S DEPARTMENT OF HEALTH IS REQUESTING COMMENTS REGARDING ITS NATIONAL...
Ireland’s Department of Health (the “Department”) recently reported on its website that it is “developing a National Biosimilar Medicines Policy to promote the use of biosimilar medicines and to create...
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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...
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Fresenius Kabi Announces Submission of Application for Biosimilar of Humira...
Fresenius Kabi today announced it has submitted an application seeking marketing authorization for its biosimilar version of Humira® (adalimumab) in the EU. This is Fresenius Kabi’s first biosimilar...
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IMS Health Report “The Impact of Biosimilar Competition” is Released
Last week, IMS Health released a report entitled “The Impact of Biosimilar Competition”. The report is an update of an earlier May 2015 report that noted that biosimilar uptake could save European and...
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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....
View ArticleClik here to view.
IMS Health Report “The Impact of Biosimilar Competition” is Released
Last week, IMS Health released a report entitled “The Impact of Biosimilar Competition”. The report is an update of an earlier May 2015 report that noted that biosimilar uptake could save European and...
View ArticleClik here to view.
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....
View ArticleClik here to view.
Guidance on Biosimilar Submission Requirements in Canada
Health Canada, the federal regulatory authority that evaluates the safety, efficacy, and quality of drugs available in Canada recently released a revised Guidance Document on Information and Submission...
View ArticleClik here to view.
EMA Releases Informational Guide on Biosimilars for Healthcare Providers
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...
View ArticleClik here to view.
Ireland’s Department of Health is Requesting Comments Regarding its National...
Ireland’s Department of Health (the “Department”) recently reported on its website that it is “developing a National Biosimilar Medicines Policy to promote the use of biosimilar medicines and to create...
View ArticleClik here to view.
Mylan Partners with Fujifilm Kyowa Kirin Biologics
Last week, Fujifilm Kyowa Kirin Biologics (FKB) and Mylan announced that they will partner with one another to commercialize in Europe FKB327, a biosimilar of adalimumab developed by FKB. As we...
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