Dive Brief:
- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has announced a positive opinion for Herzuma, Celltrion Inc.'s biosimilar version of Roche AG's cancer drug Herceptin (trastuzumab).
- The marketing authorization covers treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer, whose tumors have either HER2 overexpression or HER2 gene amplification. Similarity to the originator was confirmed through global clinical trials covering various indications.
- In the next step, the CHMP's opinion will go to the European Commission for final review.
Dive Insight:
The first European trastuzumab biosimilar, Samsung Bioepis Co., Ltd.'s Ontruzant, gained approval last month. This follows the South Korean company's European approvals for biosimilar versions of Enbrel (etanercept), Remicade (infliximab) and Humira (adalimumab).
In 2016, sales of Roche AG's Herceptin (trastuzumab) were 6.8 billion Swiss Francs ($6.8 billion) in 2016, of which 2.1 billion Swiss Francs ($2.1 billion) was in European sales. So despite the competition, the European market is still large enough for Celltrion to gain a return on its investment.
"We welcome the CHMP’s recommendation. By providing more treatment options, biosimilars open more opportunities for greater affordability and improve access to wider use of biotherapeutics. Herzuma could become a cost-effective alternative to biologics for treatment of breast cancer and gastric cancer, since biologics, which cost much more than conventional anticancer drugs, place undue financial burden on patients and the general healthcare system." said Woo Sung Kee, Chief Executive Officer of Celltrion.
Ontruzant's approval is also pending in the U.S., following a Biologics License Application submission, but it is facing competition. At the beginning of the month, the FDA approved Mylan N.V. and Biocon Ltd's Ogivri (trastuzumab-dkst) after an extended review that pushed the approval back by three months.