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NEWS

Biocon’s Yesintek (Biosimilar, Stelara) Receives Health Canada Approval for its Autoinjector Presentation

Shots: Health Canada has approved Yesintek Autoinjector (45 mg/0.05 mL & 90 mg/mL), a biosimilar version of Stelara (ustekinumab) Yesintek is indicated for the treatment of mod. to sev. plaque psoriasis in pts (≥6yrs.), active psoriatic arthritis in adults, mod. to sev. active Crohn’s disease & ulcerative colitis in adults Yesintek was previously approved as…
July 30, 2026

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NEWS

Health Canada Accepts the MAA for Kashiv BioSciences’ ADL-018 (Biosimilar, Xolair)

Shots: Kashiv BioSciences has reported that Health Canada has validated and accepted the MAA for ADL-018, a biosimilar version of Xolair (omalizumab) Omalizumab is approved for multiple allergic & inflammatory conditions, incl. mod. to sev. persistent asthma (≥6yrs.), CRSwNP (≥18yrs.), chronic spontaneous urticaria (≥12 yrs.), & IgE-mediated food allergy (>1yr.) Additionally, Alvotech & Kashiv BioSciences have…
June 5, 2026

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Celltrion
NEWS

Celltrion Seeks Canadian Approval for CT-P55 (Biosimilar, Cosentyx)  

Shots:  Celltrion has applied to Health Canada for marketing authorization for CT-P55, a biosimilar of Cosentyx (secukinumab), for all indications held by the reference product, including plaque psoriasis, psoriatic arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis  The application was based on a clinical study in 172 healthy subjects, in which CT-P55 demonstrated pharmacokinetic equivalence to the reference product and comparable…
June 1, 2026

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CuraTeQ
NEWS

CuraTeQ Biologics Receives Health Canada Approval for  Bevqolva (Biosimilar, Avastin) 

Shots:  Health Canada has granted NOC to Bevqolva (bevacizumab), a biosimilar version of Genentech’s Avastin  Bevacizumab, a humanized mAb, inhibits angiogenesis by blocking VEGF-A to slow tumor vascular growth in cancers like colorectal and lung. Marketed by Roche/Genentech as Avastin, it is available in 100 mg and 400 mg formulations  In 2025, Bevqolva received MHRA approval and was launched in the…
May 1, 2026

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NEWS

Biocon Receives Health Canada Approval for Bosaya and Vevzuo (Biosimilars, Prolia and Xgeva)

Shots: Health Canada has granted NOC to Biocon's Bosaya (60mg/mL, SC, PFS) & Vevzuo (70mg/mL, SC, single-dose vial), biosimilar versions of Amgen’s Prolia & Xgeva (denosumab) Approval was based on extensive data, incl. analytical, nonclinical, & clinical data, showing that both biosimilars matched the reference product in quality, safety & efficacy Bosaya & Vevzuo are anti-RANKL monoclonal…
April 21, 2026

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NEWS

Sobi Reports Health Canada Approval of Empaveli for C3G and Primary IC-MPGN

Shots: Health Canada has approved Empaveli (pegcetacoplan) for patients (≥12yrs.) with C3 glomerulopathy (C3G) or primary IC-MPGN to reduce proteinuria, marking the first approved therapy for these indications in Canada Approval was based on the P-III (VALIANT) study, where Empaveli demonstrated a 68% reduction in proteinuria (uPCR), stabilization of kidney function, and clearance of C3…
April 10, 2026

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NEWS

Apotex Receives Health Canada Approval for Denoza (Biosimilars, Prolia) 

Shots:  Health Canada has approved Denoza (denosumab injection), a biosimilar version of Prolia  Denoza is approved for the treatment of osteoporosis in postmenopausal women and in men at high risk of fracture. It is also authorized for all other indications of the reference biologic, as detailed in the Product Monograph  Denoza will be available in a prefilled syringe format  Ref: Apotex | Image: Apotex | Press Release…
April 7, 2026

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NEWS

NEXTBIOMEDICAL’s Nexsphere-F Receives Health Canada Approval For Musculoskeletal Pain Embolization

Shots: Health Canada has approved Nexsphere-F for the treatment of musculoskeletal pain embolization Nexsphere-F has launched the pivotal RESORB trial in the US post-IDE approval in 126 knee osteoarthritis pts comparing genicular artery embolization vs corticosteroid injections, with enrollment expected to complete in H1’26 Nexsphere-F uses resorbable microsphere tech to temporarily block abnormal blood flow…
January 30, 2026

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