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 Canadian Approval for CT-P55 (Biosimilar, Cosentyx)                  Company: Celltrion                 Product: CT-P55                   Active Ingredient: secukinumab                 Reference Product: Cosentyx                 Reference Product Company: Novartis                 Disease: All Approved Indications                 Date: Jun 01, 2026                 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 safety and immunogenicity  CT-P55, an IL-17A inhibitor, is expected to strengthen Celltrion’s autoimmune portfolio, with plans to pursue approvals in the US, Europe, and South Korea to expedite commercialization Chime Biologics & Daewoong Partner to Develop and Commercialize of Dupilumab (Biosimilar, Dupixent) in Global Markets                 Company: Chime Biologics & Daewoong                   Product: Dupilumab                 Active Ingredient: Dupilumab                 Reference Product: Dupixent                 Reference Product Company: Sanofi and Regeneron                 Disease: All Approved Indications                 Date: Jun 02, 2026                 Shots:  Chime Biologics and Daewoong Pharmaceutical signed a strategic partnership to develop and manufacture a biosimilar version of Dupixent  Chime Biologics will support Daewoong’s global biosimilar ambitions with its end-to-end development expertise, AI platform, and China’s bioprocess supply chain ecosystem  Dupilumab (Dupixent) is a mAb that blocks IL-4 and IL-13 signaling to treat Type 2 inflammation  Polpharma Biologics Partners with PSI CRO to Conduct a P-I Clinical Trial Evaluating PB018 (Biosimilar, Ocrevus)                 Company: Polpharma Biologics and PSI CRO                 Product: PB018                 Active Ingredient: Ocrelizumab                 Reference Product: Ocrevus                 Reference Product Company: Genentech                 Disease: All Approved Indications                 Date: Jun 03, 2026                 Shots:  Polpharma Biologics has partnered with PSI CRO to advance a P-I clinical trial evaluating PB018, its proposed biosimilar to Ocrevus (ocrelizumab), in multiple sclerosis pts, with the study expected to begin in October 2026  The randomized P-I study will enroll approximately 222 participants to compare the PK, PD, safety, and immunogenicity of PB018 with Ocrevus, with PK similarity as the primary endpoint and secondary assessments including B-cell depletion, MRI lesion activity, immunogenicity, and safety over 24 wks.  PB018 is an anti-CD20 mAb being developed for the treatment of relapsing and primary progressive multiple sclerosis  Xbrane Reports the US FDA Acceptance of Resubmitted BLA for Lucamzi (Biosimilar, Lucentis)                 Company: Xbrane                   Product: Lucamzi                 Active Ingredient: Ranibizumab                 Reference Product: Lucentis                 Reference Product Company: Genentech                 Disease: All Approved Indications                 Date: Jun 03, 2026                 Shots:  The US FDA has accepted the resubmitted BLA for Lucamzi, a biosimilar to Lucentis, & assigned a BsUFA action date of Oct 29, 2026  The resubmission, completed in Apr 2026, addressed issues identified in the CRL received from the FDA in Oct 2025  The product is already approved & marketed in EU as Ximluci, where it has been available since 2023 for the treatment of retinal disorders, & is intended to be  commercialized in the US under the Lucamzi brand name  Alvotech Reports the US FDA’s BLA Resubmission for AVT05 (Bisomilar, Simponi and Simponi Aria) and AVT06 (Biosimilar, Eylea)                 Company: Alvotech                   Product: AVT05 and AVT06                 Active Ingredient: Golimumab and Aflibercept                 Reference Product: Simponi & Simponi Aria and Eylea                 Reference Product Company: J&J and Bayer                 Disease: All Approved Indications                 Date: Jun 04, 2026                 Shots:  The US FDA has received resubmitted BLA of AVT05, a biosimilar version of Simponi & Simponi Aria, and AVT06, a biosimilar to Eylea 2mg (aflibercept)   Resubmissions follow Alvotech’s response to the FDA’s PAAL regarding its Reykjavik facility, alongside responses to observations from a May 2026 routine cGMP inspection & ongoing enhancements to quality systems & manufacturing operations  Under its partnership with Teva, Alvotech is responsible for the development & manufacturing of AVT05 & AVT06, while Teva handles commercialization. AVT03 is partnered with Dr. Reddy’s, which serves as the applicant for the US submission  Teva Launches Ahzantive (Biosimilar, Eylea) Across Key EU Markets                 Company: Teva                 Product: Ahzantive                 Active Ingredient: Aflibercept                 Reference Product: Eylea                 Reference Product Company: Bayer                 Disease: All Approved Indications                 Date: Jun 04, 2026                 Shots:  Teva has launched Ahzantive, a biosimilar version of Eylea, in EU, with pre-filled syringe launches beginning in May 2026 in France, Germany, Spain, & the Netherlands, and additional market launches planned later in 2026  Ahzantive received EC approval in 2025 for the treatment of wet age-related macular degeneration, diabetic macular edema, visual impairment due to myopic  choroidal  neovascularization, and macular edema following  retinal vein occlusion  The launch follows Teva’s semi-exclusive commercialization agreement with Klinge  Biopharma & Formycon, further expanding the company’s biosimilars portfolio & presence in the ophthalmology market  Health Canada Accepts the MAA for Kashiv BioSciences’ ADL-018 (Biosimilar, Xolair)                 Company: Kashiv BioSciences                 Product: ADL-018                 Active Ingredient: Omalizumab                 Reference Product: Xolair                 Reference Product Company: Genentech and Novartis                 Disease: All Approved Indications                 Date: Jun 04, 2026                 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 partnered to commercialize ADL-018 across the EEA, the UK, Switzerland, Australia, New Zealand, & Canada  Henlius Reports First US Patient Dosed in Global P-I Trial of HLX17 (Biosimilar, Keytruda)                 Company: Henlius                 Product: HLX17                 Active Ingredient: Pembrolizumab                 Reference Product: Keytruda                 Reference Product Company: Merck                 Disease: All Approved Indications                 Date: Jun 05, 2026                 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. Participants are randomized 1:1 to receive either HLX17 (200 mg Q3W for up to 12 months) or Keytruda (200 mg Q3W for 8 cycles, followed by HLX17 Q3W until 12 months).  The 1EP is to demonstrate PK similarity, assessed by AUC0–21d after the first dose and AUCss after the sixth dose. 2EPs include additional PK measures, efficacy, safety, and immunogenicity  Lupin Receives US FDA Approval for Ranluspec (Biosimilar, Lucentis)                 Company: Lupin                 Product: Ranluspec                 Active Ingredient: Ranibizumab                 Reference Product: Lucentis                 Reference Product Company: Genentech                 Disease: All Approved Indications                 Date: Jun 05, 2026                 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, retinal vein occlusion-related macular edema, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization  Alvotech Reports US FDA BLA Acceptance of AVT16 (Biosimilar, Entyvio)                 Company: Alvotech                 Product: AVT16                 Active Ingredient: vedolizumab                 Reference Product: Entyvio                 Reference Product Company: Takeda                 Disease: All Approved Indications                 Date: Jun 08, 2026                 Shots:  The US FDA has accepted BLA for AVT16, a biosimilar to Entyvio (vedolizumab) as a lyophilized vial for IV administration, to treat adults with mod. to sev.  active ulcerative  colitis & Crohn’s disease  BLA is supported by analytical, PK, & immunogenicity data demonstrating biosimilarity  between AVT16 & the reference product, plus Alvotech has filed a request  for an interchangeable biosimilar designation  In Feb 2026, Alvotech reported results from a PK study of AVT80, a SC biosimilar to Entyvio, which met all 1EPs in healthy adults. Based on regulatory guidance, the study is considered pivotal for demonstrating clinical similarity for both AVT80 & AVT16 (both under  EMA’s review)  Organon Receives the US FDA Approval for the sBLA for Tofidence (Biosimilar, Actemra)                 Company: Organon                 Product: Tofidence                 Active Ingredient: Tocilizumab                 Reference Product: Actemra                 Reference Product Company: Genentech                 Disease: All Approved Indications                 Date: Jun 10, 2026                 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 corticosteroids and respiratory support, including oxygen, mechanical ventilation, or ECMO  In 2025, Organon acquired the US regulatory and commercial rights to Tofidence, while Bio-Thera Solutions retained US manufacturing rights  GlycoNex Reports the P-III Trial Data on SPD8 (Biosimilar, Denosumab)                 Company: GlycoNex                 Product: SPD8                 Active Ingredient: denosumab                 Reference Product: Prolia                 Reference Product Company: Amgen                 Disease: All Approved Indications                 Date: Jun 10, 2026                 Shots:  GlycoNex has reported the P-III trial results assessing SPD8 (SC, Q6M), 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 equivalence margins established before unblinding  Company has completed the comparative quality & development package for both osteoporosis and bone metastasis & plans to submit MAAs to Japan’s PMDA in Q3’26 following completion of the clinical study report in Sep 2026. A Taiwan MA filing is planned for 2027, with a targeted launch by year-end 2027  Xbrane and JOINN Biologics Partner to Develop Xdarzane (Biosimilar, Darzalex)                 Company: Xbrane and JOINN Biologics                 Product: Xdarzane                 Active Ingredient: Daratumumab                 Reference Product: Darzalex                 Reference Product Company: J&J                 Disease: All Approved Indications                 Date: Jun 11, 2026                 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  The partnership enables Xbrane to progress the program without additional direct development investment while combining Xbrane’s biosimilar expertise with JOINN’s biologics development and manufacturing capabilities  Abbott Receives ANVISA’s Approval for Two Denosumab Biosimilars (Biosimilars, Prolia and Xgeva)                 Company: Abbott                 Product: Denosumab                 Active Ingredient: Denosumab                 Reference Product: Prolia and Xgeva                 Reference Product Company: Amgen                 Disease: All Approved Indications                 Date: Jun 11, 2026                 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, with Abbott responsible for registration and commercialization across key emerging markets in LATAM, Southeast Asia, the Middle East, and Africa  Celltrion receives ANVISA approval for Eydenzelt (Biosimilar, Eylea)                 Company: Celltrion                 Product: Eydenzelt                 Active Ingredient: Aflibercept                 Reference Product: Eylea                 Reference Product Company: Bayer                 Disease: All Approved Indications                 Date: Jun 15, 2026                 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)  SteinCares Receives ANVISA Approval for Uztok (Biosimilar, Stelara)                 Company: SteinCares                 Product: Uztok                 Active Ingredient: Ustekinumab                 Reference Product: Stelara                 Reference Product Company: J&J                 Disease: All Approved Indications                 Date: Jun 15, 2026                 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  CinnaGen Reports the EC Approval of Zandoriah (Biosimilar, Forsteo)                 Company: CinnaGen                 Product: Zandoriah                 Active Ingredient: Teriparatide                 Reference Product: Forsteo                 Reference Product Company: Eli Lilly and Company                 Disease: All Approved Indications                 Date: Jun 16, 2026                 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 form of parathyroid hormone that stimulates new bone formation by activating osteoblasts, while also increasing calcium absorption and reducing calcium loss through urine  Samsung Bioepis & Organon Expand Deal to Commercialize Pyzchiva (Biosimilar, Stelara) in Canada                 Company: Samsung Bioepis & Organon                   Product: Pyzchiva                 Active Ingredient: Ustekinumab                 Reference Product: Stelara                 Reference Product Company: J&J                 Disease: All Approved Indications                 Date: Jun 18, 2026                 Shots:  Samsung Bioepis & Organon have expanded their development & commercialization agreement for Pyzchiva, biosimilar version of Stelara (ustekinumab), with launch expected in 2026  As per the deal, Organon will gain exclusive commercialization rights to Pyzchiva in Canada, while Samsung Bioepis retains responsibility for development, manufacturing, & regulatory activities.  The addition of Pyzchiva expands the companies’ Canadian biosimilar collaboration portfolio from five to six products, incl. Hadlima (adalimumab), Brenzys (etanercept),  Renflexis  (infliximab), Aybintio (bevacizumab), and Ontruzant (trastuzumab)  CSPC Pharmaceutical Reports the NMPA Approval of Secukinumab Injection (Biosimilar, Cosentyx)                 Company: CSPC Pharmaceutical                 Product: Secukinumab Injection                 Active Ingredient: Secukinumab                 Reference Product: Cosentyx                 Reference Product Company: Novartis                 Disease: All Approved Indications                 Date: Jun 18, 2026                 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 presented at upcoming scientific conferences and published in peer-reviewed journals.  Secukinumab is a fully human IgG1 mAb that selectively targets IL-17A, blocking its interaction with the IL-17A receptor  Organon and Henlius Launch Bildyos and Tuzemty (Biosimilars, Prolia and Xgeva) in Canada                 Company: Organon and Henlius                   Product: Bildyos and Tuzemty                   Active Ingredient: Denosumab                 Reference Product: Prolia & Xgeva                 Reference Product Company: Amgen                 Disease: All Approved Indications                 Date: Jun 23, 2026                 Shots:  Organon & Henlius Biotech have reported availability of Bildyos (60mg/1mL) & Tuzemty (120mg/1.7mL), biosimilar versions of Prolia & Xgeva (denosumab), respectively, in Canada for all indications of reference products  Under a 2022 agreement, Henlius granted Organon exclusive global commercialization rights, excl. China, for multiple biosimilars, incl. Bildyos & Tuzemty  Denosumab is a mAb that works by targeting RANKL, which regulates bone metabolism & osteoclast formation  Samsung Bioepis Reports Clinical Data on SB27 (Biosimilar, Keytruda)                 Company: Samsung Bioepis                 Product: SB27                 Active Ingredient: Pembrolizumab                 Reference Product: Keytruda                 Reference Product Company: Merck                 Disease: All Approved Indications                 Date: Jun 29, 2026                 Shots:  Samsung Bioepis has reported the P-I & P-III trial results on SB27, a proposed biosimilar to Keytruda (pembrolizumab), which met their 1EP, with trial completion expected within 2026  The P-I trial (n=163) evaluated PK, efficacy, safety, & immunogenicity of SB27 vs EU & US-sourced Keytruda in resected stage II/IIIA NSCLC pts after adjuvant Pt-based CT, which demonstrated PK bioequivalence  The P-III trial evaluated efficacy, safety, PK, & immunogenicity of SB27 vs Keytruda, both with pemetrexed & carboplatin, in 555 pts with metastatic non-squamous NSCLC, demonstrating equivalent ORR at Wk. 24 & comparable safety, PK, & immunogenicity  Orion Pharma Partners with Shilpa Medicare to Commercialize Nivolumab Biosimilar in the EU                 Company: Orion Pharma and Shilpa Biologicals                 Product: Nivolumab                 Active Ingredient: Nivolumab                 Reference Product: Opdivo                 Reference Product Company: BMS                 Disease: All Approved Indications                 Date: Jun 30, 2026                 Shots:  Orion Pharma has entered into an agreement with Shilpa Biologicals to commercialise IV nivolumab biosimilar that is currently under development, across Europe  As per the deal, Orion will gain exclusive right to distribute, market & sell the biosimilar in the EU, while Shilpa will supply the product & receive certain development & regulatory milestone payments from Orion  Nivolumab is a PD-1 immune checkpoint inhibitor that restores anti-tumor immune response by harnessing the body’s immune system for the treatment of multiple cancers  Note: The following drug has been granted CHMP; however, no PR was available:            Denosumab Ascend (Biosimilar, Xgeva)   Nylaspeg (Biosimilar, Neulasta)  Related Post: Key Biosimilars Events of May 2026   The post Key Biosimilars Events of June 2026  appeared first on PharmaShots.