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Biosimilars - Articles and news items


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…

biosimilar etanercept

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…

David Elder

Foreword: Biosimilars – future prospects

Issue 3 2016 / 30 June 2016 / Dave P. Elder, JPAG chair and Consultant

Biologically-derived drugs, such as proteins, peptides and monoclonal antibodies (mABs), are playing an increasingly important role in global healthcare. It was recently reported that mAB therapeutics sell for over $50 billion globally. However, one of the major downsides of biological therapeutics is their significantly greater costs compared with small molecule drugs, which puts an increased burden on global health services…

Global Biotechnology Centre

Pfizer invests big in biosimilar production in China

Industry news / 28 June 2016 / Victoria White, Digital Content Producer

Pfizer is to invest $350 million in the development of a state-of-the-art Global Biotechnology Centre in the Hangzhou Economic Development Area…


Study finds biosimilar switching not suitable for all patients

Industry news / 10 June 2016 / Victoria White, Digital Content Producer

A study presented at EULAR showed that when antibodies develop in response to the infliximab, they also cross-react with the biosimilar of infliximab…


Efficacy and safety of Biogen’s anti-TNF biosimilars presented at EULAR

Industry news / 9 June 2016 / Victoria White, Digital Content Producer

Data demonstrating long-term comparable efficacy, safety and immunogenicity of Benepali (etanercept) and Flixabi (infliximab) have been presented at EULAR…


Infliximab biosimilar Flixabi approved in the EU

Industry news / 31 May 2016 / Victoria White, Digital Content Producer

The EC has granted marketing authorisation in the European Union (EU) for Flixabi, an infliximab biosimilar referencing Remicade…


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