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Key Biosimilars Events of June 2026 

Shots:  June 2026 saw strong biosimilar momentum with key approvals and regulatory milestones, including Ranluspec (US FDA), Tofidence sBLA (US FDA), Liyoubao (NMPA), Zandoriah (EC),  and multiple ANVISA approvals, alongside submissions for CT-P55 (Health Canada) and ADL-018 (Health Canada), expanding treatment options across immunology,  ophthalmology,  oncology, osteoporosis, and reproductive medicine.  Strategic collaborations between Chime Biologics–Daewoong, Polpharma Biologics–PSI CRO, Xbrane–JOINN, Samsung Bioepis–Organon, and Orion Pharma–Shilpa Biologicals advanced global biosimilar development and commercialization.  Commercial and clinical progress accelerated with the EU launch of Ahzantive, Canadian launches of Bildyos and Tuzemty, FDA acceptance of multiple BLA submissions, first patient dosing of HLX17, and positive late-stage data for SB27 and SPD8, highlighting continued global biosimilar market expansion.  Celltrion Seeks…

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EMA Marketing Authorization of New Drugs in May 2026    

Shots:  The European Medicines Agency (EMA) advanced multiple marketing authorizations and positive opinions in May 2026 across pulmonology, oncology, rare diseases, immunology, aesthetics, and endocrinology, involving companies including Boehringer Ingelheim, Novartis, AstraZeneca, AbbVie, Pharming, and Amgen.  CHMP positive opinions included Jascayd for idiopathic pulmonary fibrosis and progressive pulmonary fibrosis, Vijoice for PIK3CA-related overgrowth spectrum (PROS) disorders, Camizestrant (Etcamah) for ESR1-mutated advanced breast cancer,…

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CSPC Pharmaceutical Reports the NMPA Approval of Secukinumab Injection (Biosimilar, Cosentyx) 

Shots:  The Chinese NMPA has accepted the marketing application for its secukinumab injection, a biosimilar version of Cosentyx, submitted as a Class 3.3 therapeutic biologic  The marketing authorization application is supported by a P-I PK similarity study in healthy volunteers and a P-III equivalence study in psoriasis pts, demonstrating that the product is highly similar to Cosentyx in efficacy, safety, PK, and immunogenicity. Detailed results will be…

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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…

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Celltrion

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  …

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Abbott

Abbott Receives ANVISA’s Approval for Two Denosumab Biosimilars (Biosimilars, Prolia and Xgeva) 

Shots:  The ANVISA has approved two denosumab biosimilars (60 mg and 120 mg), a biosimilar version of Prolia and Xgeva in Brazil, expanding access to treatments for osteoporosis and cancer-related bone complications  The P-III SIMBA study confirms that Abbott's MB09 denosumab biosimilar demonstrates efficacy and safety comparable to the reference biologic, providing equivalent protection against bone loss in postmenopausal women  In 2023, mAbxience and Abbott partnered to develop, manufacture, and supply denosumab biosimilars,…

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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 …

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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…

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The US FDA New Drug Approvals in May 2026 

Shots:  The US FDA approved eight therapies in May 2026 across oncology, cardiovascular disease, infectious diseases, anesthesia, and antimicrobial resistance, reflecting continued regulatory momentum in addressing both rare and prevalent diseases.   Key approvals included Veppanu (breast cancer), Beqalzi (mantle cell lymphoma), Baxfendy (hypertension), Hepcludex (HDV infection), Decnupaz (BPDCN), Zaynich (cUTI), Cypsedo (general anesthesia), and Xocova (COVID-19 PEP).   Overall, May 2026 underscored the FDA’s commitment to advancing innovative medicines, precision therapies, and expanded patient access,…

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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,…

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