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The P-III trial of Eydenzelt vs Eylea (aflibercept) in diabetic macular edema (DME) patients achieved its 1EP of BCVA improvement at wk.8, demonstrating equivalent efficacy, safety & immunogenicity
The P-III study of Stoboclo & Osenvelt vs Prolia & Xgeva (denosumab) in patients (n=479) achieved its 1EP, showing equivalent efficacy in lumbar spine bone mineral…
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The P-III trial of Eydenzelt vs Eylea (aflibercept) in diabetic macular edema (DME) patients achieved its 1EP of BCVA improvement at wk.8, demonstrating equivalent efficacy, safety & immunogenicity
The P-III study of Stoboclo & Osenvelt vs Prolia & Xgeva (denosumab) in patients (n=479) achieved its 1EP, showing equivalent efficacy in lumbar spine bone mineral…
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The Health Canada has granted approval to Celltrion’s Omlyclo, a biosimilar version of Xolair (omalizumab)
The approval was based on clinical outcomes incl. P-III trial assessing the safety, efficacy & PK/PD of Omlyclo vs Xolair in patients with chronic idiopathic urticaria (CIU) for over 40wks., depicting therapeutic equivalence b/w the drugs
Omlyclo (75mg/0.5mL &…
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The third quarter of 2024 highlights major acquisitions in the pharma and biotech industry along with clinical trial results and approvals. The highlight of the quarter was Eli Lilly's acquisition of Morphic Holdings for ~$3.2B
This quarter also showcased multiple clinical trial results including Roche's P-I Study Data of CT-996 to treat Obesity
Our…
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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
The major highlights were the US FDA’s approval of Sandoz’s Enzeevu for Treating Neovascular Age-Related…
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Following the CHMP’s positive opinion in Jun 2024, the EC has approved SteQeyma, a biosimilar version of Stelara (ustekinumab), for treating various chronic inflammatory diseases. Approved as biologic for gastroenterology, dermatology & rheumatology indications
Approval was supported by the P-III trial of SteQeyma vs Stelara for moderate to severe plaque PsO, with 1EP as…
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Health Canada has approved Steqeyma injection & Steqeyma I.V. (injection, solution for IV infusion), biosimilar versions of Stelara (ustekinumab) to treat adults with moderate to severe active Crohn’s disease & plaque PsO as well as active psoriatic arthritis
Approval was supported by the P-III trial of Steqeyma vs Stelara, with the 1EP as rate…
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Following the CHMP’s recommendation for marketing authorization in Mar 2024, the company’s Omlyclo (biosimilar to Xolair) has obtained the EC’s approval for treating allergic asthma, chronic spontaneous urticaria (CSU) and chronic rhinosinusitis with nasal polyps (CRSwNP)
The approval was supported by the results from P-III clinical evaluation to determine the safety, efficacy & PK…
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EMA received CHMP’s recommendation to grant marketing authorization for full-label application of Celltrion’s CT-P39, developed as a biosimilar to Xolair (omalizumab). The company expects to receive EC’s approval by early May 2024
Xolair is a monoclonal antibody approved for the treatment of various indications incl. Allergic Asthma, Nasal Polyps, and Chronic Hives. Recently, Xolair…
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Celltrion has reported BLA submission for CT-P39, biosimilar version of Xolair (omalizumab), to the US FDA for all indications as of the reference product incl. asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), IgE-mediated food allergy (US only) & CSU
The submission was supported by the data, showing comparable efficacy & safety, from P-III study…

