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Biosimilars - Articles and news items

Sandoz proposed biosimilars recommended for EU approval

Industry news / 25 April 2017 / Niamh Marriott, Junior Editor

CHMP has adopted positive opinions, separately recommending the approval of both Sandoz’s biosimilar rituximab and biosimilar etanercept in Europe…

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Global trade bodies issue guidance on biosimilar switching

Industry news / 9 March 2017 / European Pharmaceutical Review

EFPIA, EBE and IFPMA issue joint guidance for prescribers on switching between original reference biologics and biosimilars…

Biosimilars create opportunities for sustainable cancer care

Blog, Z Homepage promo / 22 February 2017 / Professor Josep Tabernero, Chair of the ESMO Cancer Medicines Working Group

Dr Josep Tabernero explains the benefits of biosimilars, showing how they can create sustainable, safe and affordable access to medicine globally…

FDA to review Mylan and Biocon’s biosimilar application

Industry news / 17 February 2017 / 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…

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…