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.
(Source: Novartis)
Filed Under: Drug Discovery
