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Biocon
Biocon Ltd on Thursday said its arm Biocon Biologics Ltd has received an approval from Health Canada for chronic autoimmune conditions treatment medications Yesintek and Yesintek IV. The notice of compliance (NOC) granted by Health Canada is for Yesintek (ustekinumab injection) and Yesintek IV (ustekinumab for injection, solution for intravenous infusion), Biocon Ltd said in a regulatory filing. Yesintek and Yesintek IV are biosimilars to Stelara (ustekinumab injection) and Stelara IV (ustekinumab for injection, solution for intravenous infusion), respectively. The approval was granted on October 17, paving the way for Canadian commercial availability in mid-October, the company said. "Health Canada's approval of Yesintek marks a significant milestone in our mission to expand global access to high-quality biosimilars," Biocon Biologics CEO & Managing Director Shreehas Tambe said. He further said, "Building on our successful US launch, this approval strengthens our presence in ...
Biocon chief Kiran Mazumdar-Shaw on Tuesday met Chief Minister Siddaramaiah and his deputy D K Shivakumar and greeted them on the occasion of Diwali, official sources said. Shaw has been critical of Bengaluru's infrastructure woes by highlighting them through her social media posts, and has been repeatedly urging the state government to intervene. "Biocon chief Kiran Muzumdar-Shaw visited Cauvery (CM's official residence) and wished Chief Minister Siddaramaiah on Diwali. Legislative Council Chairman Basavaraj Horatti was present on the occasion," the CM's office said in a statement. Shah met Shivakumar at his Sadashivanagar residence in Bengaluru, the Deputy CM's office said. The state government has come under criticism over the poor state of roads and traffic issues in the city for some time now, with industry veterans like former Infosys CFO Mohandas Pai and Shaw repeatedly openly urging the state government to immediately intervene. Faced with mounting criticism from industry
Biotechnology firm Biocon on Wednesday said its unit has inked a settlement and license agreement with Amgen Inc., paving the way for commercialisation of two biosimilars used in the treatment of osteoporosis and cancer-related bone conditions. Biocon Biologics has inked the pact with Amgen Inc for the commercialisation of Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq) in the US, the company said in a regulatory filing. Bosaya 60 mg/mL injection in a single-dose prefilled syringe (PFS) and Aukelso 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial are biosimilars to Amgen's Prolia and Xgeva, respectively. These products are used in the treatment of osteoporosis and cancer-related bone conditions. Biocon Biologics and Amgen executed the settlement agreement to resolve the pending patent litigation at the US District Court for the District of New Jersey, the Bengaluru-based firm said. The agreement enables Biocon Biologics to launch Bosaya and Aukels
Biocon Ltd on Thursday said it has inaugurated its first manufacturing facility in the US, located in Cranbury, New Jersey. The company's wholly-owned subsidiary, Biocon Generics Inc. (BGI), operates the plant. Biocon acquired the Oral Solid Dosage (OSD) facility from Eywa Pharma Inc in 2023 and has since invested over USD 30 million to establish a plant with an annual production capacity of 2 billion tablets. A few products have already been commercialised from the site, with several more in the pipeline, the Bengaluru-based firm said in a statement. This investment helps Biocon diversify its manufacturing base, strengthen its supply chain and accelerate the expansion of its global footprint, it added. "Biocon's first USFDA-approved formulations facility in New Jersey marks a new chapter in our journey of global expansion," Kiran Mazumdar-Shaw, Chairperson of Biocon Group, said. The facility reflects the company's long-term commitment to deeper engagement with healthcare provide