Please login to the form below

Not currently logged in
Email:
Password:

Neupogen will be first biologic on FDA biosimilars pathway

US regulator will review Novartis’  version of Amgen's Neupogen (filgrastim) over the coming months
FDA headquarters White Oak

Novartis yesterday had its application for a biosimilar version of Amgen's Neupogen (filgrastim) accepted for review in the US.

The FDA will spend the next few months assessing the drug, which is a copy of Amgen's biological treatment for the side effects of chemotherapy.

Sandoz - the generics arms of Novartis - now becomes the first company to have a biologic accepted for FDA review under the agency's biosimilars pathway. The pathway was created in the Biologics Price Competition and Innovation Act of 2009 but has taken several years to come to fruition, with the latest clarification of terms in May this year.

The decision is an important step for biosimilars in the US, which is behind markets such as South Korea and Europe where cheaper copies of off-patent biological treatments are more available.

Mark McCamish, head of global biopharmaceutical and oncology injectable development at Sandoz, explained the significance of biosimilar products to the healthcare industry in the US.

"As they've done in Europe and other highly-regulated markets around the world, biosimilars are poised to increase US patient access to affordable, high-quality biologics, while reducing the financial burden on payers and the overall healthcare system,” said McCamish.

Sandoz already markets a biosimilar version of filgrastim under the brand name Zarzio in 40 countries outside the US. According to the company, it is the leading granulocyte colony-stimulating factor (G-CSF) in Europe, with 30 per cent of the market share.

The global biosimilars market is expected to grow to $23bn by 2019 and is an area of increasing interest - and concern - for many of the major pharma companies.

Sandoz is one of the leaders in the area, holding a 50 per cent share of the biosimilars market in Canada, Europe, Japan and Australia with products such as anaemia therapy Binocrit, a copy of Janssen's Eprex (epoetin alfa). The company also has six molecules in phase III clinical trials/filing preparation.

Other leading companies with a growing interest in the area include Boehringer Ingelheim and Lilly. The partners are planning a biosimilar version of Sanofi's leading basal insulin Lantus, although due to a technicality the drug is not classified as a biosimilar by the FDA.

Article by
Thomas Meek

25th July 2014

From: Sales, Healthcare

Share

Tags

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Swordfish Advertising

Born out of a desire to make things simple. Swordfish is a Healthcare agency, but not any old Healthcare agency....

Latest intelligence

Free White Paper: Customer Experience for Pharma
To learn why an effective customer experience strategy is vital for pharma, download our white paper “Customer experience for pharma” to learn more....
How ethical is your brand plan? Introducing the hEQ.
Assess your brand plan’s Healthcare Ethics Quotient and see how these questions can give your brand plan a new perspective and engage your internal teams and external customers....
solution_options.png
Why e-detailing must give options to healthcare professionals
We know, we know. You want to talk about your treatment right away, but this really is an essential step that will make your e-detailing even more credible....