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These agreements include key placements on national and regional formularies.
Express Scripts added Yesintek to its National Preferred Formulary (NPF) effective 21 March 2025. Cigna included Yesintek on its commercial formulary starting 21 March 2025. UnitedHealthcare has added Yesintek to various formularies: commercial from 01 May 2025; managed Medicaid from 01 March 2025; and Medicare from 01 June 2025.
CVS Health will include Yesintek beginning 01 July 2025, and Optum Rx will add it to its premium and select formularies from 01 July 2025.
Furthermore, Yesintek has been selected on formularies by Navitus, Costco Health Solutions, MedImpact, Priority Health, University of Pittsburgh Medical Center (UPMC), and numerous other regional health plans.
Notably, Blue Cross Blue Shield of Michigan (BCBSM), Florida Healthcare Plan, and several closed-door health systems have designated Yesintek as their exclusive ustekinumab product.
BBL is also in the final stages of securing formulary agreements with additional commercial carriers, the company stated.
Yesintek, a monoclonal antibody that inhibits IL-12 and IL-23 signaling associated with immune-mediated diseases, received U.S. FDA approval in December 2024.
It is approved for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
Shreehas Tambe, CEO & managing director, Biocon Biologics, said: “Yesintek (Ustekinumab kfce) represents an important milestone for Biocon Biologics, as this is the first product we have launched in the United States as a fully integrated biosimilars company.
The strong adoption of Yesintek by payors in the U.S. reflects their confidence in our science, supply reliability, and commercial capability.”
Biocon Biologics, a subsidiary of Biocon, is a fully integrated, global biosimilars company. It has commercialized eight biosimilars in key emerging markets and advanced markets. It has a pipeline of 12 biosimilar assets under development across diabetology, oncology, immunology, ophthalmology, and other non-communicable diseases.
Biocon is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets.
Biocon is a biopharmaceutical company manufacturing APIs, and generic formulations. It is also involved in research and development.
The company’s consolidated net profit declined 96.2% to Rs 25.10 crore in Q3 FY25 as compared with Rs 660 crore in Q3 FY24. Net sales increased 6.3% to Rs 3773 crore in Q3 FY25.
Meanwhile, the company’s board also approved to increase authorized share capital from existing Rs 625 crore divided into 125 crore equity shares of Rs 5 each to Rs 700 crore divided into 140 crore equity shares of Rs 5 each, subject to the receipt of necessary approvals including approval of the shareholders of the company and other regulatory / statutory approvals.
The counter rose 0.57% to end at Rs 335.85 on Wednesday, 23 April 2025.
The Board also approved increase in authorised share capital from Rs 625 crore to Rs 700 crore (dividend into 1,40,00,00,000 equity shares of Rs 5 each).
Biocon Biologics (BBL), subsidiary of Biocon, announced today a settlement and license agreement with Regeneron that clears the way to commercialize Yesafili™ (aflibercept-jbvf), an interchangeable biosimilar aflibercept, in the United States. YESAFILI, a vascular endothelial growth factor (VEGF) inhibitor, is used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product EYLEA® (aflibercept).
Biocon Biologics and Regeneron executed the settlement agreement to dismiss the pending appeal at the United States Court of Appeals for the Federal Circuit (USCAFC) of patent US11084865 (‘865 patent) and the pending litigation at the U.S. District Court for the Northern District of West Virginia, Clarksburg Division.
This agreement enables the Company to launch in the United States in the second half of calendar year 2026 or earlier in certain circumstances. The terms of the settlement are confidential.
YESAFILI is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). It is highly similar to the reference product Eylea® (aflibercept). Data shows that YESAFILI has comparable quality, safety, and efficacy to Eylea®.
As part of the settlement, Biocon Biologics and Regeneron agreed to dismiss ongoing litigation related to U.S. patent no. US11084865. This includes the pending appeal at the United States Court of Appeals for the Federal Circuit and the case in the U.S. District Court for the Northern District of West Virginia, Clarksburg Division.
While the financial and commercial terms of the settlement remain confidential, the agreement enables Biocon Biologics to potentially commercialize Yesafili in the U.S. starting in the second half of 2026—or earlier, depending on certain conditions.
The company has also secured a Canadian launch deal for Yesafili no later than 1 July 2025.
Shreehas Tambe, CEO & managing director, Biocon Biologics, said: 'This settlement clears the path for Biocon Biologics to be among the first to bring a reliable, high-quality aflibercept biosimilar to patients and healthcare providers in the United States. As the first-to-file interchangeable biosimilar to Eylea, YESAFILI affirms our scientific strength and marks our strategic entry into Ophthalmology, expanding our footprint in the U.S. and advancing our mission to increase access to life-changing treatments.'
Biocon is an innovation-led global biopharmaceuticals company. On a consolidated basis, its net profit slumped 96.20% to Rs 25.10 crore while net sales rose 6.32% to Rs 3773 crore in Q3 December 2024 over Q3 December 2023.