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Biosimilars - Articles and news items

FDA accepts Mylan and Biocon’s biosimilar biologics license application

Industry news / 12 January 2017 / Niamh Marriott, Digital Editor

This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast cancers…

B is for Biosimilars

Blog / 15 November 2016 / 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.

Mabion sign supply and commercialisation agreement with Mylan

Industry news / 10 November 2016 / 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. for its biosimilar…

Mylan and Biocon submit FDA application for Trastuzumab biosimilar

Industry news / 9 November 2016 / 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…

Biosimilars: litigation outlook

Issue 5 2016 / 20 October 2016 / Dominic E. Adair, Bristows LLP

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, biosimilar monoclonal antibodies (mABs) will […]

Pharmaceutical patents: Clear the way but careful where you tread

Blog, Z Homepage promo / 27 September 2016 / 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…

The legal framework applicable to biosimilars in the EU

Issue 4 2016 / 24 August 2016 / Hilary Jones, Bristows LLP

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.
Both generic and innovator companies are players in the biosimilars market, and such drug products can present potential savings for payers. In certain cases biosimilars have gained over 90% of the market share within one to two years of launch. This article examines the process for the approval of biosimilars in the EU; the way in which safety and risk management is conducted; and market access issues…

Samsung Bioepis seeks EU approval for its biosimilar adalimumab candidate, SB5

Industry news / 18 July 2016 / 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…

Celltrion Healthcare on Remsima and biosimilars

Blog, Z Homepage promo / 15 July 2016 / European Pharmaceutical Review

With Remsima being on the market for a year, European Pharmaceutical Review caught up with Celltrion Healthcare to find out more about biosimilars…

FDA committee recommends approval of Sandoz’s biosimilar etanercept

Industry news / 14 July 2016 / Victoria White, Digital Content Producer

The Arthritis Advisory Committee voted unanimously in support of biosimilar etanercept for all five indications of the reference product…

Sandoz announces EGALITY trial results for biosimilar etanercept

Industry news / 7 July 2016 / 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…

Celltrion to develop assay for evidence-based decision-making in anti-TNF treatment

Industry news / 5 July 2016 / 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…

 

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