Sandoz US woes continue with biosimilar rejection

In Novartis’ recently released Q1 results, which largely beat analysts’ estimates, Sandoz was a black spot on its record – with sales of the generics unit down by 18%.

Only adding to its troubles in the US market, it just announced that the FDA has issued a complete response later in regards to the unit’s application for its biosimilar GP2013.

The biosimilar would have entered the market as an analogue to Roche and Biogen’s MabThera/Rituxan, which managed to reap sales of $7.9 billion globally for the companies last year.

The unit stated: "Sandoz stands behind the robust body of evidence included in the regulatory submission and is currently evaluating the content of the letter. While disappointed, Sandoz remains committed to further discussions with FDA in order to bring this important medicine to US patients as soon as possible."

Details on why the biosimilar was knocked back were not revealed in the press release but, judging from the statement, the company is set to return to the agency to attempt to push for the BLA to be accepted.

The rejection comes as something of a surprise, given that rituximab is already approved as Rixathon in the EU.

The European Commission based its approval of data from a Phase 3, which confirmed there was no clinically meaningful difference between Sandoz’s biosimilar and the originator.

It received approval in June 2017 and in its first quarter results, Novartis pointed towards growth of European sales of biopharmaceuticals of Sandoz to be mainly driven by the biosimilars Rixathon and Erelzi. Global sales within this area grew by 13%.

Rumours broke out in February that Novartis was looking to sell the generics unit but the rumours have since died down. However, if its struggles in the US market continue to weigh it down and its biosimilar route to growth doesn’t develop as planned then those rumours are likely to reappear.

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