
EMA Accepts Sandoz’s Regulatory Filing for Biosimilar Rituximab
Sandoz is seeking approval for the same indications as Roche’s reference product MabThera.
Sandoz, a Novartis division,
According to Sandoz, the company has included, in the regulatory submission, data to demonstrate that its biosimilar version has essentially the same biological substance as, and the final drug product is highly similar to, the reference product. In addition to analytical, functional, and preclinical data, the submission includes data from two pivotal confirmatory safety, pharmacokinetic/pharmacodynamics, and efficacy studies that involved 629 follicular lymphoma and 173 rheumatoid arthritis patients.
The company’s CEO and division head, Richard Francis, said in a
The biosimilar version of rituximab is part of the Sandoz’s expanding oncology and immunology portfolios. The oncology portfolio includes two marketed products (filgrastim and epoetin-alfa) and biosimilar candidate pegfilgrastim, which is under regulatory review in the US and EU.
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