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RDY 资讯
RDY 事件
Fresenius Kabi Receives FDA Approval for Rituximab Biosimilar
Fresenius Kabi, an operating company of Fresenius (FSNUY), announced that the U.S. Food and Drug Administration has approved a rituximab biosimilar developed by Dr. Reddy's Laboratories, a biosimilar to Rituxan. Under an exclusive commercialization agreement, Fresenius Kabi holds exclusive rights to commercialize the biosimilar in the United States. The product was developed, manufactured, and submitted for approval by Dr. Reddy's Laboratories (RDY). "FDA approval of rituximab biosimilar represents an important milestone for Fresenius Kabi, further strengthening our U.S. biosimilars footprint with a well-established molecule that strategically complements our oncology and immunology portfolios. This reinforces our commitment to expanding patient access to high-quality, affordable biologic medicines in the U.S. market," said Dr. Sang-Jin Pak, President Biopharma at Fresenius Kabi.
Innoviva Signs Exclusive Distribution Agreement with Dr. Reddy's for XACDURO
Innoviva Specialty Therapeutics, a subsidiary of Innoviva (INVA), announced that it has entered into an exclusive distribution and licensing agreement with Dr. Reddy's Laboratories (RDY) for the development and commercialization of XACDURO, co-packaged for intravenous use, in South and Central America, the Caribbean, Russia and Commonwealth of Independent States countries. Under the terms of the agreement, Dr. Reddy's will be responsible for development, regulatory and commercialization activities in the licensed territory. Innoviva Specialty Therapeutics will retain rights to XACDURO in all unlicensed territories and is eligible to receive an upfront payment, regulatory and commercial milestone payments, and tiered royalties on net sales in the licensed territory.
Dr. Reddy's Laboratories Launches First-to-Market Bosutinib Tablets 400mg in the U.S.
Dr. Reddy's Laboratories announced the first-to-market launch of Bosutinib Tablets 400mg, a generic equivalent of Bosulif, in the United States, expanding its oncology portfolio and reinforcing its commitment to improving patient access to affordable, high-quality medicines. Dr. Reddy's has collaborated with MSN Laboratories Private on this product. Dr. Reddy's holds the exclusive marketing rights for the product in the United States. MSN is responsible for the development and manufacturing of the product.
Alvotech Resubmits Biologics License Applications for AVT05 and AVT06 to FDA
Alvotech (ALVO) announced the resubmission to the FDA of biologics license applications, or BLAs, for AVT05, a proposed biosimilar to Simponi and Simponi Aria, and AVT06, a proposed biosimilar to Eylea 2 mg. Under a partnership with Teva (TEVA), Alvotech is responsible for the development and manufacturing of AVT05 and AVT06, while Teva is responsible for commercialization. The resubmissions follow the submission of Alvotech's response to the FDA's post-application action letter, or PAAL, related to the company's Reykjavik manufacturing facility. In addition, the company has submitted responses to observations from a routine cGMP surveillance FDA inspection at the facility, completed in May. The company expects the FDA to conduct a six-month review of the resubmitted applications, consistent with the applicable regulatory timelines. AVT03, Alvotech's proposed biosimilar to Prolia and Xgeva, is partnered with Dr. Reddy's (RDY) which, as applicant, is responsible for the U.S. regulatory submission.
Dr. Reddy's Launches Generic Semaglutide Injection in Canada
Dr. Reddy's Laboratories announced the launch of its generic Semaglutide Injection in Canada. Dr. Reddy's is among the first companies to introduce a generic Semaglutide Injection in the Canadian market, following the Notice of Compliance, NOC, received from Health Canada on April 28th, 2026. Canada is the first G7 country to grant market authorization for Semaglutide Injection. The launch demonstrates Dr. Reddy's readiness to ensure patient access following approval.
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