Insights+ Key Biosimilars Events of August 2024
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Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
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Biosimilars are expected to be a cost-effective alternative to the high-priced branded biologics, offering significant and much-needed cost savings to both payers and patients
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The major highlights were the US FDA’s approval of Sandoz’s Enzeevu for Treating Neovascular Age-Related Macular Degeneration and Health Canada’s Approval of Celltrion’s Steqeyma for Treating Various Chronic Inflammatory Conditions. Our team at PharmaShots has summarized 8 key events of the biosimilar space of August 2024
1. Xbrane Biopharma Reclaims Rights of BIIB801 (Biosimilar, Cimzia) from Biogen
Active Ingredient: Certolizumab pegol
Date: August 01, 2024
Product: BIIB801
Reference Product: Cimzia
Company: Xbrane Biopharma
Disease: Crohn’s Disease, Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis
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Xbrane Biopharma will reclaim full rights of BIIB801 from Biogen after the termination of their commercialization and license agreement. BIIB801 is a biosimilar version of Cimzia (certolizumab pegol), under non-clinical development
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The agreement was signed b/w Xbrane & Biogen in Feb 2022, under which Xbrane received a non-refundable $8M upfront. It has been terminated due to Biogen's strategic review and Xbrane will get full rights to the program
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Xbrane has begun an out-licensing process to find a new development & commercialization partner & has received significant interest for the same. The production has been scaled up with Xbrane’s contract manufacturer, with clinical material production in 2024, enabling clinical trials in 2025
Active Ingredient: Ustekinumab
Date: August 01, 2024
Product: Steqeyma
Reference Product: Stelara
Company: Celltrion
Disease: Crohn’s Disease, Plaque Psoriasis & Psoriatic Arthritis
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Health Canada has approved Steqeyma injection & Steqeyma I.V. (injection, solution for IV infusion), biosimilar versions of Stelara (ustekinumab) to treat adults with moderate to severe active Crohn’s disease & plaque PsO as well as active psoriatic arthritis
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Approval was supported by the P-III trial of Steqeyma vs Stelara, with the 1EP as rate of change in the psoriasis area & severity index for skin symptoms after 52wks. The efficacy was similar in patients who switched to Steqeyma at wk.16
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Steqeyma, an IL-12 & -23 antagonist, is accessible in both IV [130mg/26 mL (5mg/mL) solution in a single-dose vial] & SC (45mg/0.5mL or 90mg/1mL solution in a single-dose, prefilled syringe) formulations
Active Ingredient: Ranibizumab
Date: August 05, 2024
Product: LUBT010
Reference Product: Lucentis
Company: Lupin
Disease: Neovascular Age-related Macular Degeneration (wet AMD)
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Lupin has concluded P-III study evaluating the efficacy, safety & immunogenicity of LUBT010 (0.5mg, intravitreal, QM for 1yr.) vs Lucentis in wet AMD adults (n=600) across India, US, EU & Russia
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The trial met its 1EP, showing therapeutic equivalence in visual acuity improvement plus similarity in safety & immunogenicity b/w both the drugs. Results will form the basis of approval across the US & EU
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Ranibizumab is a recombinant humanized IgG1 kappa isotype mAb intended for treating wet AMD, macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) & myopic choroidal neovascularization (mCNV)
Active Ingredient: Aflibercept-abzv
Date: August 09, 2024
Product: Enzeevu
Reference Product: Eylea
Company: Sandoz
Disease: Neovascular Age-Related Macular Degeneration
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The US FDA has approved Enzeevu, biosimilar version of Eylea (aflibercept), 2mg vial kit & pre-filled syringe for intravitreal injection for enhanced & sustained visual acuity among neovascular age-related macular degeneration (nAMD) patients
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Approval was supported by the analytical & preclinical in vitro results plus data from Mylight trial, assessing Enzeevu (aflibercept-abzv) vs Eylea in nAMD patients (n=485) for 52wks., that demonstrated similar efficacy, safety & immunogenicity b/w Enzeevu & Eylea
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Enzeevu, a recombinant fusion protein, inhibits abnormal vessel growth by binding with VEGF-A & PlGF. It is injected into the eye among nAMD patients for enhancing visual acuity & slowing disease progression
5. EMA Accepted the Marketing Application of Alvotech’s AVT06 a Biosimilar of Eylea (aflibercept)
Active Ingredient: Aflibercept
Date: August 15, 2024
Product: AVT06
Reference Product: Eylea
Company: Alvotech
Disease: Eye Disorders
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Alvotech reported EMA’s acceptance of its marketing application for AVT06, a biosimilar to Eylea used to treat eye disorders, and reported global sales of $5.9B. The company expects its marketing approval in Q3’25
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Alvotech will develop and supply the AVT06, while Advanz Pharma will register and have exclusive commercialization rights in Europe except for France and Germany, where Biogaran holds semi-exclusive rights
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On Jan’24, Alvotech reported the positive top-line data from its trial (AVT06-GL-C01) comparing the efficacy, safety, and immunogenicity of AVT06 with Eylea in patients with neovascular (wet) AMD, Furthermore, the company is also developing a high dose biosimilar of Eylea i.e. AVT29 (8mg)
6. GlycoNex Reports the Completion of P-I Study Assessing SPD8 (Biosimilar, Prolia) for Osteoporosis
Active Ingredient: Denosumab
Date: August 16, 2024
Product: SPD8
Reference Product: Prolia
Company: GlycoNex
Disease: Osteoporosis
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GlycoNex, in partnership with Mitsubishi Gas Chemical Company, has concluded the P-I trial assessing SPD8, biosimilar version of Prolia (denosumab), for treating osteoporosis. Both the companies have completed the P-I study across Japan
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Based on these results, SPD8 will proceed to P-III trial aimed at assessing its efficacy, safety & immunogenicity among larger patient population with osteoporosis, for which the company is in discussion with regulatory authorities. Trial is planned in Q4’24
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The P-I trial in healthy postmenopausal women reached its 1EPs, depicting similar PK/PD & safety b/w SPD8 vs denosumab
Active Ingredient: Secukinumab bsm
Date: August 16, 2024
Product: BAT2306
Reference Product: Cosentyx
Company: Bio-Thera Solutions and Pharmapark
Disease: Plaque Psoriasis
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Pharmapark will hold exclusive distribution, and marketing rights & filing for BAT2306 (Secukinumab bsm) which has finished the P-I & P-III study globally and plans to submit applications for approval to the NMPA, EMA & FDA.
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Under the terms of the agreement, BAT2306 will be developed & supplied by Bio-Thera at its Guangzhou, China facility, and Pharmapark will be responsible for the regulatory & commercial activities across Russia and CIS countries
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This is a third expansion of the existing agreement between the two companies which includes BAT2506 (Biosimilar, Golimumab) also includes BAT2206 (Biosimilar, Ustekinumab)
Active Ingredient: Ustekinumab
Date: August 26, 2024
Product: SteQeyma
Reference Product: Stelara
Company: Celltrion
Disease: Gastroenterology, Dermatology & Rheumatology
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Following the CHMP’s positive opinion in Jun 2024, the EC has approved SteQeyma, a biosimilar version of Stelara (ustekinumab), for treating various chronic inflammatory diseases. Approved as biologic for gastroenterology, dermatology & rheumatology indications
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Approval was supported by the P-III trial of SteQeyma vs Stelara for moderate to severe plaque PsO, with 1EP as rate of change in the PASI for skin symptoms, showing similar safety & efficacy b/w both the drugs
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SteQeyma (CT-P43), a human IL-12 & IL-23 antagonist, is available as SC injections (45mg/0.5mL or 90mg/1mL in a single-dose, prefilled syringes) & IV infusion (130mg/26mL solution in a single-dose vial)
Related Post: Insights+ Key Biosimilars Events of July 2024
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com
