miércoles, 27 de julio de 2016

Sandoz / Novartis apuesta por "biosimilares".

Novartis on Monday announced that progress in its biologics pipeline "paves the way" for five planned global launches of biosimilar products by 2020. Richard Francis, head of Novartis' Sandoz unit, suggested "we are committed to significantly broadening patient access to biologics…over the next few years," adding that the company "can become a real partner for payers and healthcare systems in making sure they can manage their budgets.

Francis specified that Novartis will likely launch biosimilar versions of AbbVie's Humira (adalimumab), Amgen's Enbrel (etanercept) and Neulasta (pegfilgrastim), Johnson & Johnson's Remicade (infliximab) and Roche's Rituxan (rituximab) within the next four years. The five drugs amassed combined sales of approximately $44 billion in 2015, according to Novartis

The company indicated that it would pursue an "aggressive" strategy that involves the submission of 11 regulatory filings between 2015 and 2017, noting that Sandoz has already announced six of these in the last 12 months. Most recently, the European Medicines Agency accepted the drugmaker's submission for its Rituxan biosimilar in May. Meanwhile, Novartis said Sandoz's early-stage pipeline includes assets in oncology and other specialty therapeutic areas, "with plans to start new programmes every year." The company also suggested that investments of more than $1 billion, from 2010 through to 2020, in two bio-manufacturing facilities in Austria "position Sandoz to deliver biosimilars at an unprecedented scale.

Novartis launched its Omnitrope (somatropin) biosimilar referencing Pfizer's recombinant human growth hormone Genotropin (somatropin) in Europe in 2006, marking the first availability of a biosimilar therapy anywhere globally.  
Novartis later became the first company to receive Japanese approval of a biosimilar when regulators there cleared Somatropin in 2009, while Zarxio (filgrastim-sndz), its follow-on version of Amgen's Neupogen (filgrastim), was launched in the US last year. (Ver)
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