List view / Grid view
17 February 2017 | By Niamh Marriott, Digital Editor
The US Food and Drug Administration (FDA) has accepted Mylan and Biocon's biologics license application for MYL-1401H, a proposed biosimilar to Neulasta...
12 January 2017 | By Niamh Marriott, Digital Editor
This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers...
15 November 2016 | By Niamh Louise Marriott, Digital Content Producer
B is for Biosimilar - the next instalment of our daily pharmaceutical alphabet bringing you up to date with all the latest news and research on the subject of biosimilars.
10 November 2016 | By Niamh Louise Marriott, Digital Content Producer
Mabion signed a long-term development and commercialisation agreement with Mylan Ireland a wholly owned subsidiary of Mylan N.V.
9 November 2016 | By Niamh Louise Marriott, Digital Content Producer
Mylan and Biocon have submitted a biologics license application for MYL-1401O, a proposed biosimilar trastuzumab, to the FDA through the 351(K) pathway...
20 October 2016 | By European Pharmaceutical Review
In this issue: Biosimilars, Informatics, Ingredients, PAT, HPLC, Microbiology, Product Showcase, Regulation, and much more...
In the Foreword article contributed by Consultant David P. Elder in Issue 3, 2016 of European Pharmaceutical Review, entitled ‘Biosimilars: future prospects’, Dr Elder concluded that it is likely that biosimilars will become increasingly established in both Europe and the United States and that in addition to proteins and peptides,…
27 September 2016 | By Dominic Adair and Emma Muncey, Bristows
Top litigators Dominic Adair and Emma Muncey review patent court cases to identify the legal steps you should take when marketing a biosimilar...
Biosimilars are becoming increasingly important in the European Union’s biopharmaceutical landscape due to the increased growth of biologicals as key therapies and the financial pressure this puts on healthcare budgets.
18 July 2016 | By Victoria White, Digital Content Producer
At an estimated $4billion a year, the reference product, Humira, is among the European Union's largest single drug expenditures...
With Remsima being on the market for a year, European Pharmaceutical Review caught up with Celltrion Healthcare to find out more about biosimilars...
14 July 2016 | By Victoria White, Digital Content Producer
The Arthritis Advisory Committee voted unanimously in support of biosimilar etanercept for all five indications of the reference product...
7 July 2016 | By Victoria White, Digital Content Producer
The EGALITY study involved 531 patients and compared the efficacy and safety of biosimilar etanercept with the originator product, Enbrel...
5 July 2016 | By Victoria White, Digital Content Producer
Celltrion is to develop laboratory tests that will enable physicians to identify when patients on an anti-TNF drug require a change of dose...
In this issue: Biosimilars, Regulation, Packaging, Microfluidics, Microbiology, PAT, Antibiotic Resistance, and much more...
