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.
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
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
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
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
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
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
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
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
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
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)
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
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
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
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
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)
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
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
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)
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
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
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
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
