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NEWS

CinnaGen Reports the EC Approval of Zandoriah (Biosimilar, Forsteo)

Shots: The EC has granted centralized marketing authorization to Zandoriah, a biosimilar version of Forsteo (teriparatide) for the treatment of osteoporosis in adults, across all 30 EEA states Zandoriah has demonstrated biosimilarity in line with EMA guidelines, with comprehensive comparability studies confirming similar quality, safety, and efficacy to the reference product Teriparatide is a synthetic…
June 16, 2026

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NEWS

SteinCares Receives ANVISA Approval for Uztok (Biosimilar, Stelara) 

Shots:  The ANVISA has approved Uztok, a biosimilar version of Stelara (ustekinumab)  Ustekinumab is a human interleukin-12 and -23 antagonist  Uztok is indicated for Plaque psoriasis, Psoriatic arthritis, Crohn's disease, and Ulcerative colitis  Ref: Gov.br |   Image: SteinCares | Press Release Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea   PharmaShots, your go-to media platform for customized news ranging across multiple indications. For more information, connect with…
June 15, 2026

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Celltrion
NEWS

Celltrion Receives ANVISA Approval for Eydenzelt (Biosimilar, Eylea) 

Shots:  The ANVISA has approved Eydenzelt, a biosimilar version of Eylea (aflibercept)  Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor  Eydenzelt is indicated for adults with wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (CRVO/BRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (CNV)  Ref: Gov.br |   Image: Celltrion   | Press Release Related News: Celltrion Plans to File for Approval of Herzuma SC (Biosimilar, Herceptin) in Europe and Korea  …
June 15, 2026

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NEWS

Xbrane and JOINN Biologics Partner to Develop Xdarzane (Biosimilar, Darzalex) 

Shots:  Xbrane Biopharma and JOINN Biologics have entered a strategic partnership to provide customized development services for Xdarzane, a biosimilar version of Darzalex (daratumumab)  Under the agreement, JOINN will advance Xdarzane through pilot-scale process development, analytical similarity studies, and process optimization for commercial manufacturing. Xbrane will lead global out-licensing efforts, while both companies will collaborate on further development, scale-up, clinical studies, regulatory filings, and commercialization …
June 11, 2026

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NEWS

GlycoNex Reports the P-III Trial Data on SPD8 (Biosimilar, Denosumab)

Shots: GlycoNex has reported the P-III trial results assessing SPD8 (SC, Q6M), a biosimilar version of denosumab co-developed with Mitsubishi Gas Chemical, vs Prolia in 266 Japanese subjects with osteoporosis Trial met its 1EP, with SPD8 demonstrating therapeutic equivalence to Prolia. The between-group difference in the 1EP & its 95% confidence interval fell within the pre-specified…
June 11, 2026

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NEWS

Organon Receives the US FDA Approval for the sBLA for Tofidence (Biosimilar, Actemra) 

Shots:  The US FDA has approved sBLA for Tofidence, a biosimilar version of Actemra (tocilizumab)  Tofidence is an IL-6 receptor antagonist available in 80 mg/4 mL, 200 mg/10 mL, and 400 mg/20 mL single-dose vials for IV. The expanded approval adds indications for CAR T cell-induced severe or life-threatening cytokine release syndrome (CRS) and hospitalized adults and children (≥2 years) with COVID-19 requiring…
June 10, 2026

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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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NEWS

Lupin Receives US FDA Approval for Ranluspec (Biosimilar, Lucentis) 

Shots:  The US FDA has approved Ranluspec (ranibizumab-hkdz), a biosimilar version of Lucentis (ranibizumab)  Ranluspec is an interchangeable ranibizumab biosimilar approved in the US, available in both vials and PFS at 0.3 mg (0.05 mL of 6 mg/mL) and 0.5 mg (0.05 mL of 10 mg/mL) strengths, matching Lucentis  It is a recombinant humanized IgG1 mAb fragment that inhibits VEGF-A and is indicated for wet age-related macular degeneration,…
June 5, 2026

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Henlius Reports First US Patient Dosed in Global P-I Trial of HLX17 (Biosimilar, Keytruda) 

Shots:  Shanghai Henlius has dosed the first US patient in the global P-I trial of HLX17, a biosimilar version of Keytruda (pembrolizumab), for the adjuvant treatment of multiple resected solid tumors  P-I multicentre study evaluates the PK, efficacy, safety, and immunogenicity of HLX17 vs Keytruda in pts with resected solid tumors, including non-small cell lung cancer, melanoma, and renal cell carcinoma.…
June 5, 2026

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