- Celltrion and Teva Pharmaceutical gained approval of their Herceptin biosimilar Herzuma from the Food and Drug Administration, the second biosimilar approval for Celltrion within a month.
- The approval is for adjuvant and metastatic HER2-positive breast cancer, in association with a companion diagnostic.
- The approval should provide a boost for both Celltrion and Teva, following the Complete Response Letter for the drug back in April after manufacturing issues at Celltrion. It poses yet another challenge for Roche's top-selling drug.
Roche's Herceptin (trastuzumab), Rituxan (rituximab), and Avastin (bevacizumab) all face biosimilar challenges that could threaten the company's income and growth.
In its third quarter earnings, European Herceptin sales fell 10%, Rituxan by 48% and Avastin by 2%. Herceptin is the company's biggest seller, and sales in the U.S. are second only to Rituxan.
The relative youth of the U.S. biosimilars market means it's not yet clear how big an impact there will be from this approval of Herzuma (trastuzumab-pkrb), and the recent approval of another Herceptin biosimilar from Mylan and Biocon.
Roche execs insist the U.S. threat isn't going to be that dramatic. On the third quarter earnings call, Daniel O'Day, head of the company's pharmaceuticals division, said there was a difference between the erosion rates in U.S. and Europe, which he said was likely to be due to the more heterogenous nature of the U.S. healthcare system limiting uptake.
However, things could still change for Roche. In late November, Celltrion and Teva picked up FDA approval for Truxima (rituximab-abbs), the first Rituxan biosimilar to be approved in the U.S. When the Truxima and Mvasi (bevacizumab-awwb) approvals are added in, this could really begin to put the pressure onto the big pharma.
The FDA has also noticed the slow uptake of biosimilars, with FDA Commissioner Scott Gottlieb calling competition anemic. He blames this on consolidation across the supply chain and litigation delaying market access. The FDA's Biosimilars Action Plan seeks to support market competition and improve the regulatory process.
Neither of the recent biosimilar approvals for Celltrion and Teva have been easy. In April, Celltrion received CRLs for the approvals of the two drugs. The CRLs were related to an FDA warning letter from back in January for its manufacturing site in South Korea.