- Bone Health
- Immunology
- Hematology
- Respiratory
- Dermatology
- Diabetes
- Gastroenterology
- Neurology
- Oncology
- Ophthalmology
- Rare Disease
- Rheumatology
Eye on Pharma: Celltrion Wins Japanese Trastuzumab Case
Republic of Korea-based Celltrion has won a court decision that declared patents on Roche’s Herceptin invalid in Japan.
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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Global Biosimilar Market Projected to Reach $1.3 Trillion by 2032
April 11th 2024The global biosimilar market is projected to surge from $25.1 billion in 2022 to approximately $1.3 trillion by 2032, with a compound annual growth rate of 17.6%, driven mainly by the increasing prevalence of cancer and the cost-effectiveness of biosimilars, as outlined in a report by Towards Healthcare.
