Celltrion Gains the European Commission's Authorization for Biosimilar Trastuzumab, Herzuma

Celltrion announced on Tuesday that the European Commission (EC) has granted a marketing authorization for Herzuma, Celltrion’s biosimilar trastuzumab referencing Herceptin, for the treatment of HER2-positive early breast cancer, metastatic breast cancer, or metastatic gastric cancer.

Final approval of the biosimilar follows a December 2017 positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The EC’s decision allows Herzuma to be marketed in the 28 member states of the European Union, as well as in Norway, Liechtenstein, and Iceland.

“The development of [biosimilars] is of great importance in the field of oncology, and has the potential to enrich our therapeutic arsenal against a variety of diseases and to increase patients’ accessibility to innovative drugs at a more affordable price,” said Woo Sung Kee, CEO of Celltrion.

While a launch date for the biosimilar has not yet been announced, a representative from Celltrion Healthcare, Celltrion’s marketing arm, told Korean media in 2017 that Herzuma could be launched in Europe as soon as 3 months following EC approval. Celltrion’s head of strategy and operations, Ho Ung Kim, told reporters this week that the intravenous Herzuma could be launched at as much as a 50% discount to a subcutaneously administered presentation of the reference Herceptin.

Celltrion also filed a Biologics License Application for the trastuzumab biosimilar with the FDA in July 2017, but recent regulatory challenges have put a potential US approval date into question; while a regulatory decision on Herzuma was expected in March 2018, Celltrion received a warning letter from the FDA on January 30 that raised issues with the company’s manufacturing practices.

In a February 1 statement on the letter, Celltrion said that the warning did not impact the company’s ability to make its biosimilar infliximab, Inflectra, but did not disclose how the warning would impact Herzuma. However, Celltrion’s partner, Teva, told investors that FDA approval of both Herzuma and a proposed rituximab biosimilar would likely be delayed while Celltrion remediates the issues at the facility.

The company also faces ongoing legal challenges for Herzuma in the United States; Celltrion and Teva have filed a lawsuit against Genentech (sponsor of the reference Herceptin) in a California district court, seeking a declaratory judgment that 38 patents covering Herceptin are invalid, unenforceable, or not infringed by Celltrion’s product. The patents include those addressing methods of production, dosage, methods of treatment, and extending time to disease progression, among others.