Tagged as: Coherus

Coherus and Xbrane Announce Acceptance of Regulatory Submissions for Ranibizumab Biosimilars

On October 1, 2021, Coherus BioSciences announced that FDA has accepted for review Coherus’ BLA for CHS-201, a candidate biosimilar to Lucentis® (ranibizumab), which is indicated for neovascular age-related macular degeneration (nAMD) and several other ophthalmic conditions. The BLA was originally submitted by Coherus’ partner, BioeqAG.  On October 4, 2021,…

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Recent Launches – Formycon, bioeq and Boryung, Samsung Bioepis

On August 5, 2021, Formycon and Bioeq announced submission of the biologics license application for FYB201 to the U.S. Food and Drug Administration.  FYB201 is a biosimilar candidate to Lucentis(R)1 (Ranibizumab), which is used in the treatment of neovascular (wet) macular degeneration and other serious eye diseases.  If approved, Coherus…

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Recent Adalimumab Biosimilar Updates

On February 15, 2021, Celltrion Healthcare announced that the European Commission granted marketing authorization for Yuflyma™ (CT-P17), an adalimumab biosimilar, on February 11, 2021.  Yuflyma™ was approved across all thirteen intended indications covered by the reference biologic, Humira®.  Yuflyma™ is a high concentration, low-volume and citrate-free adalimumab biosimilar, which, according…

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Coherus Neulasta biosimilar loses preferred status at Express Scripts

Last week it was announced that Coherus BioSciences’s pegfilgrastim biosimilar Udencya would be excluded from Express Scripts’s preferred formulary starting January 1, 2021. The pharmacy benefit manager’s preferred Neulasta biosimilars for next year are Mylan’s Fulphila and Sandoz’s Ziextenzo.

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EYLEA (Aflibercept) Biosimilar Development Updates (Part 2)

Regeneron’s EYLEA (aflibercept) was approved by the U.S. FDA on November 18, 2011 and is indicated for the treatment of patients with Neovascular (Wet) Age-related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). As previously reported, Momenta in collaboration with Mylan began…

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Biosimilars Development Updates: Mylan’s Pipeline, Coherus’s Adalimumab aBLA, Amgen’s Eculizumab Biosimilar

Mylan announced on its most recent quarterly earnings call that it expects to launch its rituximab and etanercept biosimilars in Europe later this year. In discussing Mylan’s biosimilars pipeline, Rajiv Malik, Mylan’s President, told market analysts, “we also have for Europe rituximab and Enbrel biosimilars, which will be most likely…

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Coherus and Amgen Stipulate to Dismissal of Adalimumab Infringement Case

As we previously reported, earlier this year Coherus filed a complaint against Amgen in the District of Delaware alleging infringement of patents claiming “stable aqueous pharmaceutical compositions” comprising adalimumab and other components.  Coherus alleged that “Amgen is actively offering for sale and selling Amgevita™ [Amgen’s tradename for its adalimumab biosimilar…

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Amgen Answers Coherus’s Adalimumab Complaint

As we previously reported, on January 24, 2019, Coherus filed a complaint against Amgen in the District of Delaware alleging that Amgen’s adalimumab product for sale in Europe, Amgevita™, infringes three Coherus formulation patents related to adalimumab because Amgen allegedly manufactures its European product in the United States.  As we also reported, Coherus amended its…

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Coherus Settles with AbbVie, and Sues Amgen, Over Adalimumab Biosimilars (Updated)

Coherus announced today that it has executed settlement agreements with AbbVie that grant Coherus global, non-exclusive, royalty-bearing license rights under AbbVie’s intellectual property to commercialize CHS-1420, Coherus’ proposed adalimumab biosimilar.  According to the press release, the “global settlements resolve all pending disputes between the parties related to Coherus’ adalimumab biosimilar,” with Coherus’s…

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