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.