US FDA issues biosimilar CRL to ‘disappointed’ but determined Sandoz

By Flora Southey contact

- Last updated on GMT

Getty/canbedone
Getty/canbedone
The US FDA has rejected Sandoz’s proposed biosimilar version of Biogen and Roche’s Rituxan (rituximab).

Sandoz – a division of Novartis – announced receipt of the complete response letter (CRL) on Tuesday. The firm’s biologics license application (BLA) was accepted for review​ by the US Food and Drug Administration (FDA) in September last year.

“Sandoz is currently evaluating the contents of the letter and discussing next steps with the Agency,” ​spokesperson Eric Althoff told us.

In a statement​ published this week, the firm said it was “disappointed”, but “committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible.”

Roche and Biogen’s rituximab – marketed as Rituxan by Genentech and Biogen Idec in the US, and as MabThera by Roche in the rest of the world except Japan – is a therapeutic antibody that binds to the CD20 antigen on cancerous and non-cancerous B-cells.

Rituxan first received FDA approval in 1997 for the treatment of refractory, low-grade or follicular, CD20-positive, B-cell Non-Hodgkin Lymphoma (NHL) as a single agent.

Sandoz is not the only firm struggling to bring a rituximab biosimilar product to market.

Last month, we reported​ the FDA has issued Celltrion – which is collaborating with Teva on biosimilar versions of Rituxan (rituximab) and Herceptin (trastuzumab) – CLRs, following a warning letter​ dated January, 2017.  

Related topics: Markets & Regulations, Biosimilars

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