Sandoz, a subsidiary of Novartis, has previously secured approval for its biosimilar to Biogen's Rituxan (rituximab), a treatment for rheumatoid arthritis, in the European Union, Japan, Australia and Switzerland.
However, when the company presented data for its Rituxan alternative, Rixathon, to the US Food and Drug Administration (FDA), the agency requested additional information to complement the submission.
A spokesperson for Sandoz stated the company was “disappointed to have to make this decision for the US market but stands behind the safety, efficacy and quality of [its] proposed medicine.”
When asked to explain how the FDA reached a differing decision to other regulators, the spokesperson responded that “each agency applies its own interpretation and experience to complex submissions, which can total tens of thousands of pages of data. This can lead to differences in the types and number of questions that each file receives.”
In a statement, Stefan Hendriks, global head of biopharmaceuticals at Sandoz, explained that the delay that would ensue in arranging to provide the additional data would see the “marketplace needs […] be satisfied”.
Rituxan brought in global sales of approximately $7.9bn (€6.9bn) in 2017, and there are several companies waiting in the wings to satisfy the ‘marketplace need’ for a biosimilar.
Celltrion and commercialisation partner Teva are closest to market, despite having experienced manufacturing issues along the way. Pfizer is also well advanced in the development of its own biosimilar.
Despite the regulatory setback, the spokesperson for Sandoz pointed towards its market-leading position; the firm holds eight biosimilar approvals worldwide.