Partners Teva/Celltrion Seek the Jump on Pfizer, Launch Their Rituximab Biosimilar Next Week

When Pfizer announced its intention just more than a week ago to begin marketing its rituximab biosimilar Ruxience® in January 2020, industry watchers wondered when we might hear a response from its sole approved competitor. The wait was over quickly: Teva and Celltrion will begin shipping their own rituximab biosimilar Truxima® on November 11.

Truxima was approved in October 2018 for the cancer indications of Genentech’s reference product Rituxan®. In a joint press release issued by both companies, Brendan O’Grady, Teva’s Executive Vice President and Head of North America Commercial Operations, stated, “We are excited about the first FDA-approved biosimilar to rituximab in the US. Teva’s commitment to biosimilars is focused on the potential to create lower healthcare costs and increased price competition. This focus is consistent with Teva’s mission of making accessible medications to help improve the lives of patients.”

The press release also mentioned a key detail of the partners’ patent settlement with Genentech. Specifically, Celltrion and Teva will be able to market the autoimmune indications (rheumatoid arthritis, granulomatosis, with polyangiitis, and microscopic polyangiitis) in the second quarter of 2020, assuming they receive approval from the Food and Drug Administration for the broader indications. Ruxience is not currently indicated for these same autoimmune disorders.

The partners announced that the wholesale acquisition cost (WAC) for Truxima will be just 10% below that for Rituxan, which will be subject to further discounts and rebates negotiated with individual payers. That works out to a WAC of $845.55 for 100 mg vial (or $4227.75 for 500 mg vial). Teva will be responsible for marketing Truxima in the US.

Pfizer has not yet announced their intended WAC for Ruxience’s launch in January.