Celltrion and Teva announced that the FDA has approved Herzuma (trastuzumab-pkrb), a biosimilar referencing Roche's Herceptin (trastuzumab), for the treatment of certain patients with HER2-overexpressing breast cancer. Specifically, Herzuma was cleared for the adjuvant treatment of patients with node-positive or node-negative breast cancer. It is also indicated for metastatic breast cancer as monotherapy for patients who have undergone one or more chemotherapy regimens for metastatic disease, or in combination with paclitaxel for use in the first-line setting. 

According to Celltrion and Teva, the FDA approval is based on a review of data from the Herzuma development programme, which showed that there were "no clinically meaningful differences in purity, potency and safety between Herzuma and Herceptin" in HER2-overexpressing breast cancer for the approved indications. The companies noted that trastuzumab products carry a boxed warning that the therapy may be associated with cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-foetal toxicity. 

"Biosimilars are of growing importance to the oncology community and the approval of Herzuma may provide more patients access to this important therapy," remarked Celltrion CEO Woosung Kee. Last month, the FDA also approved Celltrion and Teva's Truxima (rituximab-abbs), a biosimilar of Roche's Rituxan (rituximab), for use as monotherapy or in combination with chemotherapy in adults with CD20-positive, B-cell non-Hodgkin's lymphoma. 

The FDA had issued a complete response letter to Celltrion in April for both Herzuma and Truxima. The action followed a warning letter issued earlier this year citing production facility and manufacturing process issues at a Celltrion facility in South Korea.

Herzuma was granted EU approval in February, while Truxima was cleared by European regulators last year. 

"We are excited about building Teva's presence in biosimilars," commented Brendan O'Grady, head of commercial operations in North America for Teva, noting that "the addition of Herzuma to our biosimilars portfolio will allow us to leverage our strengths from oncology and generics." 

Herceptin generated sales of about $7.2 billion in 2017. Earlier this year, the US regulator declined to approve Pfizer's biosimilar version of Herceptin, saying the drugmaker needed to supply additional technical information.