The FDA issued Sandoz, a Novartis division, a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar Rituxan (rituximab). The FDA issues CRLs when they are not ready to approve a product.
Deutsche Bank analyst, Tim Race states he anticipated Rituxan sales to drop by about $150 million this year as a result of biosimilars being introduced into the market. However, with this news, Roche Pharmaceutical can rest a little easier knowing that at least for the time being, there won’t be a cheaper product competing with Rituxan (rituximab).
Sandoz says that it stands behind their product. It is currently evaluating the CRL and is “committed to further discussions” with the FDA.
Filed Under: Drug Discovery