The US Food and Drug Administration (FDA) has accepted Novartis company Sandoz’s biologics licence application (BLA) under the 351 (k) pathway for etanercept, a biosimilar to Amgen’s Enbrel drug.
Etanercept is a tumour necrosis factor alpha (TNF-alpha) inhibitor used to treat a range of autoimmune diseases, including rheumatoid arthritis and psoriasis.
In the US, rheumatoid arthritis and psoriasis affects around 1.3 million and 7.5 million people respectively.
Sandoz global biopharmaceutical and oncology injectables development head Mark McCamish said: "Anti-TNFs will continue to play a leading role in immunology treatment and the acceptance of our regulatory submission by the FDA today is a significant step towards increasing patient access to these life-changing medicines.
"We believe we are the first company to receive FDA file acceptance of a biosimilar version of etanercept."
Sandoz noted that this is its second biologics license application (BLA) submission using the 351(k) biosimilar pathway.
The BLA includes a data package that features data from analytical, functional, pre-clinical and clinical studies.
The company believes that both the pivotal clinical trials will show that the planned biosimilar is similar to the reference product.
The two trials include a pharmacokinetic (PK) study in healthy volunteers (HVs) and a confirmatory safety and efficacy study in patients with chronic plaque-type psoriasis (egality).
Recently, Sandoz launched Zarxio (filgrastim-sndz), the first biosimilar in the US.
The company has a pipeline with various biosimilars in several stages of development, including five programmes in Phase III clinical trials or registration preparation, while it aims to make ten regulatory submissions over the next three years.
Sandoz provides a portfolio of around 1,100 high-quality molecules, which ranges from standard generics to complex products.