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Biocon’s Yesafili (Biosimilar, Eylea) Receives the US FDA’s Approval for Ophthalmology 

  Shots: The US FDA has approved Yesafili (aflibercept-jbvf), biosimilar to Eylea, for treating neovascular (wet AMD) age-related macular degeneration as well as visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), DME & myopic choroidal neovascularization (myopic CNV) The approval was supported by analytical, nonclinical & clinical data…

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Insights+ Key Biosimilars Events of February 2024

Insights+ Key Biosimilars Events of February 2024

Shots:Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency  Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients  During February, Sandoz received Health Canada’s approval for Jubbonti while Rani Therapeutics…

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Biocon,Bayer and Regeneron

Biocon Enters into an Exclusive License Agreement with Bayer and Regeneron for the Commercialization of Yesafili (biosimilar, aflibercept) into the Canadian Market 

Shots: Biocon, Bayer & Regeneron have signed an agreement to commercialize and distribute Yesafili, the biosimilar version of Eylea (aflibercept) Injections across Canada  Under the terms of the agreement, Biocon has set Jul 1, 2025, as the launch date for Yesafili (2mg NDS for vials and prefilled syringes). Earlier in Mar 2023, Health Canada approved…

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Insights+ Key Biosimilars Events of December 2022

Insights+ Key Biosimilars Events of December 2022

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patientsDuring the month of December, Alvotech and STADA launched Hukyndra (biosimilar, adalimumab)…

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Insights+ Key Biosimilars Events of May 2022

Insights+ Key Biosimilars Events of May 2022

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patientsDuring the month of May, JSR Life Sciences launches Similis Bio business…

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Insights+ Key Biosimilars Events of March 2022

Insights+ Key Biosimilars Events of March 2022

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patientsDuring the month of March, Junshi & Mabwell Bioscience’s Junmaikang (biosimilar, adalimumab)…

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PharmaShots' Key Highlights of First Quarter 2022

PharmaShots’ Key Highlights of First Quarter 2022

The first quarter of 2022 highlights the approvals, clinical data & acquisitions. There are major alliances in this quarter which include Biocon acquired Viatris’ biosimilars assets for ~$3.335B, Stryker signed a definitive agreement to acquire Vocera Communications for ~$3.09B, Biohaven acquire Channel Biosciences for ~$3BThe first quarter of the year also showcases regulatory events…

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Insights+ Key Biosimilars Events of February 2022

Insights+ Key Biosimilars Events of February 2022

Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potencyBiosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and the patientsDuring the month of February, Biocon acquired Viatris’ biosimilars assets for ~$3.335B,…

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