Shots:
- Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
- 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
- A major highlight was the US FDA’s approval of Biocon Biologics’ Yesintek (Biosimilar, Stelara) to treat Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis. Our team at PharmaShots has summarized 9 key events of the biosimilar space of December 2024
1. Biocon Biologics Reports the US FDA’s Approval of Yesintek (Biosimilar, Stelara)
Active Ingredient: Ustekinumab
Date: Dec 01, 2024
Product: Yesintek
Reference Product: Stelara
Company: Biocon Biologics
Disease: Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis & Psoriatic Arthritis
Shots:
The US FDA has granted approval to the company’s Yesintek, a biosimilar version of J&J’s Stelara (ustekinumab)
Biocon Biologics will commercialize Yesintek across the US by Feb 22, 2025, following FDA approval, under a settlement and licensing agreement with Janssen
Yesintek is a monoclonal antibody indicated for the treatment of Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis
2. Intas Pharmaceuticals to Acquire Coherus BioSciences’ Udenyca Business (Biosimilar, Neulasta)
Active Ingredient: Pegfilgrastim
Date: Dec 03, 2024
Product: Udenyca
Reference Product: Neulasta
Company: Intas Pharmaceuticals & Coherus BioSciences
Disease: Febrile Neutropenia & Hematopoietic Subsyndrome of Acute Radiation Syndrome
Shots:
Intas Pharmaceuticals, through its US specialty division Accord BioPharma, has entered into an agreement to acquire Coherus’ Udenyca business (pegfilgrastim-cbqv), a biosimilar of Amgen’s Neulasta, to enhance Accord’s biosimilar product portfolio. Deal is expected to conclude in Q1’25
Udenyca is indicated to reduce infection risk from febrile neutropenia in patients with non-myeloid malignancies, on myelosuppressive anti-cancer drugs and to increase survival in those exposed to myelosuppressive radiation
Udenyca is a leukocyte growth factor available as prefilled syringe (PFS), autoinjector (AI) & on-body injector (OBI), ensuring patient’s choice & convenience
3. Celltrion’s Omlyclo (CT-P39) Secures the Health Canada’s Approval (Biosimilar, Xolair)
Active Ingredient: Omalizumab
Date: Dec 09, 2024
Product: Omlyclo
Reference Product: Xolair
Company: Celltrion
Disease: Chronic Idiopathic Urticaria, Chronic Spontaneous Urticaria & Chronic Rhinosinusitis with Nasal Polyps & Allergic Asthma
Shots:
The Health Canada has granted approval to Celltrion’s Omlyclo, a biosimilar version of Xolair (omalizumab)
The approval was based on clinical outcomes incl. P-III trial assessing the safety, efficacy & PK/PD of Omlyclo vs Xolair in patients with chronic idiopathic urticaria (CIU) for over 40wks., depicting therapeutic equivalence b/w the drugs
Omlyclo (75mg/0.5mL & 150mg/1.0mL, SC) is approved to treat patients (≥12yrs.) with chronic idiopathic urticaria (CIU) or chronic spontaneous urticaria (CSU), patients (≥6yrs.) with allergic asthma & adults having chronic rhinosinusitis with nasal polyps (CRSwNP)
4. Celltrion Secures the CHMP’s Positive Opinion for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva) and Avtozma (Biosimilar, RoActemra)
Active Ingredient: Aflibercept, Denosumab & Tocilizumab
Date: Dec 16, 2024
Product: Eydenzelt, Stoboclo & Osenvelt, Avtozma
Reference Product: Eylea, Prolia & Xgeva, RoAtemra
Company: Celltrion
Disease: Diabetic Macular Edema, Bone Mineral Density & Rheumatoid Arthritis
Shots:
The P-III trial of Eydenzelt vs Eylea (aflibercept) in diabetic macular edema (DME) patients achieved its 1EP of BCVA improvement at wk.8, demonstrating equivalent efficacy, safety & immunogenicity
The P-III study of Stoboclo & Osenvelt vs Prolia & Xgeva (denosumab) in patients (n=479) achieved its 1EP, showing equivalent efficacy in lumbar spine bone mineral density (BMD) plus similar PK/PD, safety & immunogenicity
The P-III trial of Avtozma vs RoAtemra (tocilizumab) in mod. to sev. rheumatoid arthritis patients (n=479), depicted equivalent efficacy based on DAS28-ESR scores at wk.12, as well as a sustained efficacy & a comparable safety for up to wk.52
5. Bio-Thera Solutions and SteinCares Add Another Biosimilar, Expanding their Alliance
Active Ingredient: N/A
Date: Dec 16, 2024
Product: N/A
Reference Product: N/A
Company: Bio-Thera Solutions & SteinCares
Disease: N/A
Shots:
Bio-Thera Solutions has expanded its collaboration with SteinCares, granting it exclusive rights to market a third biosimilar in Brazil and the LATAM region
Bio-Thera will handle development, the US FDA & the EMA submissions to support LATAM regulatory filings & commercial supply of each biosimilar from its Chinese manufacturing facilities
SteinCares will utilize its expertise in the LATAM healthcare system, strong footprint and marketing abilities to enable a go-to-market strategy, enhancing product access
6. The US FDA Grants Approval to Celltrion’s Steqeyma (Biosimilar, Stelara)
Active Ingredient: Ustekinumab
Date: Dec 16, 2024
Product: Steqeyma
Reference Product: Stelara
Company: Celltrion
Disease: Plaque Psoriasis, Psoriatic Arthritis, Crohn’s Disease & Ulcerative Colitis
Shots:
Celltrion has receive the US FDA’s approval for Steqeyma, biosimilar version of J&J’s Stelara (ustekinumab), to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease, & ulcerative colitis
The approval was supported by P-III study in mod. to sev. plaque psoriasis with 1EP as change in the PASI for skin symptoms, showing therapeutic equivalence b/w Steqeyma vs reference
Ustekinumab is a mAb that inhibits IL-12 and IL-23, responsible for inflammatory & immune responses. Celltrion will commercialize Steqeyma in Feb 2025 as per a settlement and license agreement with J&J
7. Dong-A ST Receives EC Approval for Imuldosa (Biosimilar, Stelara)
Active Ingredient: Ustekinumab
Date: Dec 19, 2024
Product: Imuldosa
Reference Product: Stelara
Company: Dong-A ST
Disease: Plaque Psoriasis, Psoriatic Arthritis, Crohn’s Disease & Ulcerative Colitis
Shots:
Dong-A ST received EC approval for Imuldosa (DMB-3115), a biosimilar of Janssen’s Stelara (Ustekinumab), following CHMP’s positive opinion & FDA’s approval
Imuldosa, initially developed by Dong-A Socio Holdings & Meiji Seika Pharma, & was transferred to Dong-A ST in 2020 for global development and commercialization. In 2021, it was out-licensed to Intas Pharmaceuticals for launch through subsidiaries, incl. Accord Biopharma (US) and Accord Healthcare (Europe, UK, Canada)
Ustekinumab is a fully human anti-IL-12/IL-23 mAb indicated for the treatment of plaque psoriasis, psoriatic arthritis, & Crohn’s disease
8. Bio-Thera Solutions and Tabuk Pharmaceuticals Join Forces to Commercialize BAT2206 (Biosimilar, Stelara) in Saudi Arabia
Active Ingredient: Ustekinumab
Date: Dec 24, 2024
Product: BAT2206
Reference Product: Stelara
Company: Bio-Thera Solutions and Tabuk Pharmaceuticals
Disease: Plaque Psoriasis, Psoriatic Arthritis, Crohn’s Disease & Ulcerative Colitis
Shots:
Bio-Thera Solutions has collaborated with Tabuk Pharmaceuticals to commercialize BAT2206, biosimilar of Stelara (Ustekinumab) in Saudi Arabia
The alliance will utilize Tabuk’s local footprint, sales & marketing abilities, with Tabuk handling marketing, registration, manufacturing & promotion of BAT2206. Bio-Thera will manage development & supply from its Guangzhou manufacturing facilities
BAT2206, a proposed biosimilar to Janssen’s Stelara, is a human mAb that targets IL-12 & IL-23 by inhibiting p40 binding to IL-12Rβ1 on immune cells. Bio-Thera has filed for regulatory approval with the US FDA, EMA & NMPA
9. Xbrane Biopharma Reports Resubmission of BLA to the US FDA for Ranibizumab Biosimilar Candidate
Active Ingredient: Ranibizumab
Date: Dec 24, 2024
Product: N/A
Reference Product: Lucentis
Company: Xbrane Biopharma
Disease: Wet AMD, Macular Edema following RVO, Diabetic Macular Edema, Diabetic Retinopathy & Myopic Choroidal Neovascularization
Shots:
Xbrane Biopharma has resubmitted the BLA for its biosimilar product, referencing Genentech’s Lucentis (ranibizumab), to the US FDA post issuance of CRL in Apr 2024
The CRL stated requirement for additional information on the reference standard and follow-up actions from manufacturing site inspections. Xbrane has addressed the issues, qualifying new reference standard & completing follow-up actions with its manufacturing partners
Ranibizumab is an anti-VEGF drug indicated for treating wet AMD, macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) & myopic choroidal neovascularization (mCNV)
Related Post: Key Biosimilars Events of November 2024
