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EMA accepts Sandoz proposed biosimilar pegfilgrastim for regulatory review

Saturday, October 28, 2017, 09:00 Hrs  [IST]

Sandoz, a Novartis Division, and the global leader in biosimilars, announced that its biosimilar to EU-authorized Neulasta (pegfilgrastim) has been accepted by the European Medicines Agency (EMA) for regulatory review.

Pegfilgrastim is a long-acting formulation of filgrastim (granulocyte colony-stimulating factor, or G-CSF) and Sandoz is seeking approval for use of its biosimilar in the same indication as the reference medicine.

"Our goal is to improve patient access to important biologic medicines and the EMA file acceptance of our biosimilar pegfilgrastim is a move towards doing just that," said Mark Levick, MD PhD, Global Head of Development, Biopharmaceuticals.

"At Sandoz, oncology is a key area of focus and, with our biosimilar and generic oncology medicines, we have a leading portfolio in this therapy area. If approved, we look forward to supporting cancer patients, healthcare professionals and payors with our biosimilar pegfilgrastim."

The comprehensive data package, submitted as part of the Marketing Authorization Application, includes analytical, preclinical and clinical data and strongly demonstrates that the biosimilar pegfilgrastim matches the reference medicine in terms of safety, efficacy and quality.

The clinical development program for Sandoz biosimilar pegfilgrastim includes data from phase I pharmacokinetic and pharmacodynamic studies in healthy volunteers, as well as phase III confirmatory safety and efficacy studies in breast cancer patients.  

Sandoz is committed to increasing patient access to high-quality biosimilars. As the global leader in biosimilars, Sandoz has five biosimilars marketed worldwide, as well as a leading global pipeline. We currently have three proposed biosimilars under review by the EMA: pegfilgrastim, adalimumab and infliximab.

Sandoz is well-positioned to continue leading the biosimilars industry based on our experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, we benefit strongly from this unique blend of experience and expertise in many different market environments.


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pradeep Awasthi Oct 28, 2017 12:17 PM
The recently developed biosimiliar pegfilgrastim which is a reference drug of gastrim,is a granulocyte stimulating factor and is used for treatment of cancer by Sandoz that is pioneer in biosimiliar formulations has been under the regulatory review of European medical Agency for its analytical,preclnical and clinical datas where its safety efficacy and tolerability is very well established,But still sandoz is awaiting for its approval for its marketing authorization to access this medicine for improving the quality of life of people.

Sandoz which is division of Novartis holds leadership in biosimiliar formulations has currently developed three biosimiliars which are under the regulatory review of European medical agency.

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