Eye on Pharma: Celltrion Wins Japanese Trastuzumab Case

Asian news media are reporting that Republic of Korea—based Celltrion has won a court decision that declared patents on Roche’s Herceptin invalid in Japan. The decision, reports Business News Korea’s Pulse, clears the way for Celltrion to market its trastuzumab biosimilar, Herzuma, for breast cancer in Japan.

Celltrion and its Japanese distribution partner Nippon Kayaku launched the biosimilar in the Japanese market in August 2018, but only for the indications of HER2-positive gastric cancers, for which it was approved by Japan’s Ministry of Health. Korea Biomedical Review indicated that Celltrion will now seek an indication for the treatment of breast cancer, and that the company believes it can obtain approval for this indication by early 2019.

The biosimilar was also approved in the European Union in February 2018, where it is also marketed under the brand name Herzuma. The product is not yet authorized in the United States, however, as Celltrion received a Complete Response Letter (CRL) for the drug in April 2018 from the FDA.

The CRL came after Celltrion had received the FDA’s Form 483 in 2017. Then, in February 2018, Celltrion received a warning letter from the agency related to its manufacturing processes. The drug maker has since resubmitted the product to the FDA for approval, and a regulatory decision is expected by the end of 2018.

However, despite the resubmission, Celltrion continues to face legal battles over the biosimilar in the United States. In January 2018, Celltrion and its partner Teva sought a declaratory judgment of noninfringement against Roche’s Genentech. In May 2018, Genentech was successful in its own request for the court to dismiss Celltrion and Teva’s petition.

Also in January, Genentech filed its own complaint against Celltrion and Teva, alleging that the partnership had infringed 40 patents. In June, Genentech moved to dismiss certain counterclaims, and in July, it filed a new complaint that alleged infringement of the same 40 patents covering Herceptin.