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