Celltrion's Trastuzumab Biosimilar Gains Positive CHMP Opinion

Republic of Korea-based biosimilar developer Celltrion announced on December 16 that it has received a positive opinion from the European Medicines Agency (EMA)'s Committee for Medicinal Products for Human Use (CHMP) for its trastuzumab biosimilar, referenced on Roche’s blockbuster anticancer therapy, Herceptin. The positive opinion will now be referred to the European Commission (EC) for final review.

CHMP recommended that the product, which Celltrion hopes to market in the European Union (EU) as Herzuma, be granted marketing authorization for the treatment of patients with early breast cancer, metastatic breast cancer, or metastatic gastric cancer whose tumors have either HER2 overexpression or HER2 gene amplification.

“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,” Woo Sung Kee, CEO of Celltrion, said in a statement. “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,” he added.

A representative from Celltrion Healthcare, Celltrion’s marketing arm, recently told The Investor that Herzuma could be launched in Europe as early as 3 months following its final approval by the EC. On the strength of the positive opinion, coupled with positive forecasts for Celltrion’s biosimilar infliximab (marketed in the EU as Remsima and in the United States as Inflectra) and rituximab (Truxima), some analysts say that the growing Celltrion could see its annual revenue exceed $2.7 billion by 2022.

However, Herzuma will face EU competition from other biosimilar challengers to the reference Herceptin. Samsung Bioepis’ trastuzumab biosimilar, Ontruzant, gained a positive opinion from CHMP in September 2017 and is also awaiting the EC’s final clearance. Mylan—Biocon’s Ogivri, for which the biosimilar development partnership recently resubmitted a previously withdrawn EMA marketing application, was recently approved by the FDA as the first US trastuzumab biosimilar.

Celltrion also filed a Biologics License Application (BLA) for its trastuzumab with the FDA in July 2017. The BLA includes efficacy, safety, immunogenicity, pharmacodynamic, and pharmacokinetic data from trials conducted in over 500 patients in 22 countries, and comprises data from a phase 3 equivalence trial of the proposed biosimilar as neoadjuvant treatment in HER2-positive early breast cancer. Celltrion has not disclosed a biosimilar user fee act date for this BLA.