On May 26, 2023, the European Commission granted the marketing authorization to Samsung Bioepis for EPYSQLI, a biosimilar referencing SOLIRIS (eculizumab) developed by Alexion for the treatment of the paroxysmal nocturnal hemoglobinuria (PNH) that had global sales of approximately $5 trillion last year. As the first hematology biosimilar developed by Samsung Bioepis, "EPYSQLI has demonstrated equivalence through comparative trials with original medicines," said Jang Jun-ho, the principal investigator of EPYSQLI 's phase 3 clinical trial and a Professor of the Department of Hemato-oncology at Samsung Medical Center.
On May 30, 2023, Alkem Laboratories launched CETUXA, a biosimilar referencing Merck's ERBITUX (cetuximab) for treatment of head and neck cancer. Alkem's CETUXA has been researched and manufactured by Enzene Biosciences Limited, the biological arm of Alkem. CETUXA is administered as an intravenous infusion and is available as 100 mg (2 mg/mL) in a single-dose vial. Sandeep Singh, Managing Director at Alkem, said, "[c]etuximab's reach in India is limited partly due to its high cost and only around 2 percent of eligible patients are managed by this therapy. To address this issue, we have launched an affordable biosimilar that is backed by indigenous research and production. We aim to ensure its availability in all parts of the country making it easily accessible to the Indian population."
On May 30, 2023, Sun Pharmaceutical Industries announced that its tildrakizumab injection used for treatment of plaque psoriasis, to be marketed under the brand name ILUMETRI, was approved by China's National Medical Products Administration (NMPA). Previously in June 2019, Sun Pharma out-licensed tildrakizumab to a subsidiary of China Medical System Holdings Limited, for development, regulatory filings and commercialization of the product in Greater China. Sun Pharma's tildrakizumab injection has also been approved for marketing in the US, EU, Japan, UK, Switzerland, Canada, Australia, Hong Kong and other countries/regions under the brands of ILUMYA and ILUMETRI, the company said in a BSE filing.
On May 30, 2023, Chia Tai Tianqing Pharmaceutical Group, a China-based pharmaceutical company and subsidiary of Sino Biopharm, announced that its DELITUO, a rituximab injection biosimilar referencing Roche's MABTHERA, has been approved by the NMPA for the treatment of follicular lymphoma (FL), CD20-positive diffuse large B-cell lymphoma (DLBCL), and chronic lymphocytic leukemia (CLL).
We first reported on NMPA's approvals of ILUMETRI's and DELITUO's on Big Molecule Watch's China blog. Stay up to date on biosimilar applications and approvals in China by following our Big Molecule Watch China blog.
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