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 Samsung Bioepis & Teva Partners to Commercialize Epysqli in the US. Our team at PharmaShots has summarized 15 key events of the biosimilar space of February 2025 

 

1. Lotus Pharmaceutical and Formycon Enter into a Strategic Partnership to Commercialize FYB203/Ahzantive (Biosimilar, Eylea) in APAC 

Company: Lotus Pharmaceutical and Formycon 

Product: FYB203/Ahzantive 

Active Ingredient: Aflibercept 

Reference Product: Eylea 

Reference Product Company: Bayer 

Disease: Neovascular Age-Related Macular Degeneration (nAMD) & Other Retinal Diseases     

Date: Feb 05, 2025   

Shots: 

• Formycon has signed an exclusive license agreement with Lotus Pharmaceutical to commercialize FYB203/Ahzantive in APAC countries, including Indonesia, Malaysia, Philippines, Singapore, Taiwan, Thailand, Vietnam, and Hong Kong. Additionally, Formycon will supply the finished product to Lotus 

• As per the agreement, Klinge will receive upfront and milestone payments, along with royalties on Lotus’ net sales. Formycon will participate in Klinge’s income at a mid-single to low-double-digit percentage 

• In June 2024, the FDA approved the aflibercept biosimilar FYB203, followed by EC approval in Jan 2025. Formycon and Lotus are preparing regulatory submissions in APAC countries 

 

2. Dr. Reddy’s Partners with Henlius to Commercialize HLX15 (Biosimilar, Darzalex & Darzalex Faspro) in the US & EU 

Company: Dr. Reddy’s & Henlius 

Product: HLX15 

Active Ingredient: Daratumumab 

Reference Product: Darzalex & Darzalex Faspro 

Reference Product Company: AstraZeneca 

Disease: Multiple Myeloma 

Date: Feb 06, 2025   

Shots: 

• Dr. Reddy’s & Henlius have entered into a license agreement to develop & market HLX15, biosimilar version of Darzalex & Darzalex Faspro (daratumumab) 

• As per the agreement, Dr. Reddy’s will get exclusive rights to market HLX15 (SC & IV) in the US & EU in exchange for ~$131.6M ($33M upfront + milestones), plus net sales-based royalties, while Henlius will handle HLX15’s development, manufacturing & commercial supply 

• Daratumumab (SC & IV) is an anti-CD38 fully human mAb indicated for the treatment of pts with multiple myeloma 

 

3. Bio-Thera Reports the EMA’s MAA Acceptance of BAT2506 (Biosimilar, Simponi) 

Company: Bio-Thera 

Product: BAT2506 

Active Ingredient: Golimumab 

Reference Product: Simponi 

Reference Product Company: Johnson & Johnson 

Disease: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Ulcerative Colitis 

Date: Feb 07, 2025   

Shots: 

• The EMA has accepted the MAA of BAT2506, a biosimilar version of Simponi (golimumab) 

• Approval was backed by extensive analytical characterization and biosimilarity of BAT2506 in comparison to US & EU golimumab from P-I trial in healthy subjects, plus P-III trial (vs. EU Simponi) in active PsA pts depicting non-inferior efficacy & comparable PK, safety, & immunogenicity of BAT2506 

• MAA was preceded by Bio-Thera & STADA commercialization & license agreement (May 28, 2024), granting STADA exclusive regulatory & commercial rights for BAT2506 in the EU, UK, Switzerland, & other specific regions, while Bio-Thera handles its development, manufacturing, & supply 

 

4. Samsung Bioepis and Teva Partners to Commercialize Epysqli (Biosimilar, Soliris) in the US 

Company: Samsung Bioepis and Teva Pharmaceuticals 

Product: Epysqli 

Active Ingredient: Eculizumab-aagh 

Reference Product: Soliris 

Reference Product Company: AstraZeneca 

Disease: Paroxysmal Nocturnal Hemoglobinuria, Atypical Hemolytic Uremic Syndrome, and Generalized Myasthenia Gravis  

Date: Feb 10, 2025   

Shots: 

• Samsung Bioepis and Teva have signed a development and commercialization license agreement for Epysqli (eculizumab-aagh), a biosimilar to Soliris (eculizumab), in the US   

• Under the agreement, Samsung Bioepis will manage development, regulatory registration, manufacturing, and supply, while Teva will oversee commercialization in the US. The financial terms are confidential. This deal increases Teva's biosimilar portfolio to 18 assets across multiple therapeutic areas  

• Epysqli is a complement inhibitor to treat rare diseases, including paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG) in anti-AchR antibody-positive adults 

 

5. Bio-Thera Collaborates with Intas Pharmaceuticals for the Commercialization of BAT2506 (Biosimilar, Simponi) Across the US 

Company: Bio-Thera & Intas Pharmaceuticals 

Product: BAT2506 

Active Ingredient: Golimumab 

Reference Product: Simponi 

Reference Product Company: Johnson & Johnson 

Disease: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Ulcerative Colitis 

Date: Feb 10, 2025   

Shots: 

• Bio-Thera and Intas Pharmaceuticals have entered into an exclusive commercialization and license agreement for BAT2506, a biosimilar version of Simponi (golimumab) in the US  

• As per the agreement, Bio-Thera is entitled to receive $21M upfront and an additional $143.5M in development and commercial milestones 

• BAT2506 is an IgG1 monoclonal antibody targeting TNF-alpha, reducing inflammatory markers like CRP, IL-6, ICAM-1, MMP-3, and VEGF. The reference medicine is approved in US and Europe for conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis 

 

6. Celltrion Secures the US FDA’s Approval for Avtozma IV/SC (Biosimilar, Actemra) 

Company: Celltrion 

Product: Avtozma 

Active Ingredient: Tocilizumab-anoh 

Reference Product: Actemra 

Reference Product Company: Roche 

Disease: Mod. to Sev. Rheumatoid Arthritis 

Date:  Feb 11, 2025   

Shots: 

• The US FDA has approved Avtozma IV/SC (biosimilar, Actemra) to treat rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) and COVID-19; expected to be commercially available by August 2025 in US 

• Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs Actemra (tocilizumab) in mod. to sev. RA pts demonstrated biosimilarity, change in disease activity score using 28 joints (DAS28)-ESR (1EP) at wk.24 & with 1-year results with no clinical differences in efficacy, PK, safety, and immunogenicity 

• Celltrion has commercialization rights of Avtozma SC formulation in US. Avtozma is a recombinant humanized mAb that targets the IL-6 receptor 

 

7. Samsung Bioepis Reports the US FDA’s approval of Ospomyv & Xbryk (Biosimilar, Prolia & Xgeva) 

Company: Samsung Bioepis 

Product: Ospomyv & Xbryk 

Active Ingredient: Denosumab-dssb 

Reference Product: Prolia and Xgeva 

Reference Product Company: Amgen 

Disease: Osteoporosis & Prevention of Skeletal Related Events 

Date: Feb 16, 2025   

Shots: 

• The EC has approved SB16: Ospomyv (denosumab-dssb; 60mg pre-filled syringe) & Xbryk (denosumab-dssb; 120mg vial), a biosimilar version of Prolia & Xgeva for osteoporosis & prevention of skeletal related events, respectively 

• Approval was based on the P-I trial which confirmed PK equivalence between SB16, EU-DEN & US-DEN among healthy males, in terms of AUC from time zero to infinity & maximum serum concentration (1EPs) 

• Additionally, P-III trial depicted SB16’s similar efficacy, safety, immunogenicity & PK/PD vs reference in postmenopausal osteoporosis (PMO) pts. The 1EPs of % change in lumbar spine BMD was met at 12mos., with sustained comparability up to 18mos., incl. after switching from denosumab to SB16 

 

8. Samsung Bioepis Reports the EC’s approval of Obodence & Xbryk (Biosimilar, Denosumab) 

Company: Samsung Bioepis 

Product: Obodence & Xbryk 

Active Ingredient: Denosumab 

Reference Product: Prolia and Xgeva 

Reference Product Company: Amgen 

Disease: Osteoporosis & Prevention of Skeletal Related Events 

Date: Feb 16, 2025   

Shots: 

• The EC has approved SB16: Obodence (60mg pre-filled syringe; Biosimilar: Prolia) & Xbryk (120mg vial; Biosimilar: Xgeva) for osteoporosis & prevention of skeletal related events, respectively 

• Approval was based on the P-I trial which confirmed PK equivalence between SB16, EU-DEN & US-DEN among healthy males (n=168), in terms of AUC from time zero to infinity & maximum serum concentration (1EPs) 

• Additionally, P-III trial depicted SB16’s similar efficacy, safety, immunogenicity & PK/PD vs reference in postmenopausal osteoporosis (PMO) pts (n=457). The 1EPs of % change in lumbar spine BMD at mos.12 was met, with sustained comparability up to 18mos., incl. after switching from denosumab to SB16 

 

9. Celltrion Secures the EC’s Approval for Eydenzelt (Biosimilar, Eylea), Stoboclo & Osenvelt (Biosimilars, Prolia & Xgeva) 

Company: Celltrion 

Product: Eydenzelt, Stoboclo & Osenvelt 

Active Ingredient: Aflibercept & Denosumab 

Reference Product: Eylea, Prolia & Xgeva 

Reference Product Company: Bayer & Amgen 

Disease: Diabetic Macular Edema, Bone Mineral Density & Rheumatoid Arthritis   

Date:  Feb 18, 2025   

Shots: 

• The EC has approved Eydenzelt (CT-P42, aflibercept), a biosimilar to Eylea, Stoboclo & Osenvelt (CT-P41, denosumab), a biosimilar to Prolia & Xgeva for all indications of the reference products 

• The P-III trial of Eydenzelt (40 mg/mL solution for injection in a vial & pre-filled syringe) vs Eylea (aflibercept) in diabetic macular edema (DME) patients achieved its predefined equivalence criteria and 2EP of equivalent efficacy, safety & immunogenicity 

• The P-III study of Stoboclo (60 mg solution for injection in pre-filled syringe) & Osenvelt (120 mg solution in a vial) vs Prolia & Xgeva (denosumab) in patients (n=479) achieved its 1EP, showing equivalent efficacy plus similar PK/PD, safety & immunogenicity 

 

10. Alvotech and Teva Report the Regulatory Filing Acceptance for AVT06 (Biosimilar, Eylea) Across the US 

Company: Alvotech and Teva Pharmaceuticals 

Product: AVT06/AVT29 

Active Ingredient: Aflibercept 

Reference Product: Eylea 

Reference Product Company: Bayer 

Disease: Eye Disorders 

Date: Feb 18, 2025   

Shots: 

• The US FDA has accepted the BLA of AVT06 (2mg) for treating eye disorders, including diseases that can lead to vision loss or blindness. The regulatory approval process is expected to finish in Q4’25 

• AVT06/AVT29 is a recombinant fusion protein and biosimilar candidate to Eylea (aflibercept), targeting VEGF to inhibit receptor activation, neovascularization, and vascular permeability. Teva holds US commercialization rights for AVT29 

• 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 biosimilar of Eylea i.e. AVT29 (8mg) 

 

11. Alvotech and Teva Launch Selarsdi (Biosimilar, Stelara) in the US 

Company: Alvotech and Teva Pharmaceuticals 

Product: Selarsdi 

Active Ingredient: Ustekinumab-aekn 

Reference Product: Stelara 

Reference Product Company: Johnson & Johnson 

Disease: Psoriatic Arthritis, Plaque Psoriasis, Crohn’s Disease, Ulcerative Colitis, and Pediatric Plaque Psoriasis & Psoriatic Arthritis 

Date: Feb 21, 2025   

Shots: 

• Alvotech and Teva have launched Selarsdi (ustekinumab-aekn) injection, a biosimilar to Stelara, to treat psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis across the US 

• The FDA has provisionally determined that all Selarsdi presentations can be approved as interchangeable with Stelara after exclusivity expires on Apr 30, 2025. The four approved presentations are 45 mg/0.5 mL & 90 mg/mL prefilled SC syringes, 45 mg/0.5 mL single-dose vials for SC, and 130 mg/26 mL single-dose IV infusion vials 

• In August 2020, Teva and Alvotech formed a partnership to commercialize five Alvotech biosimilars exclusively in the US. Alvotech handles development & manufacturing, while Teva manages commercialization 

 

12. Celltrion Secures the EC’s Approval for Avtozma (Biosimilar, RoActemra) 

Company: Celltrion 

Product: Avtozma 

Active Ingredient: Tocilizumab-anoh 

Reference Product: RoActemra 

Reference Product Company: Roche 

Disease: Mod. to Sev. Rheumatoid Arthritis, Active Systemic Juvenile Idiopathic Arthritis, Polyarticular Juvenile Idiopathic Arthritis, and Giant Cell Arteritis 

Date:  Feb 24, 2025   

Shots: 

• Following the US FDA approval, the EC has approved Avtozma (biosimilar, RoActemra) to treat mod. to sev. rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA), and giant cell arteritis (GCA) 

• Approval was based on the P-III trial of Avtozma (tocilizumab-anoh) vs RoActemra (tocilizumab) in mod. to sev. RA pts demonstrated biosimilarity, and change in disease activity score using 28 joints (DAS28)-ESR (1EP) at wk.12 & the final results supported comparability in secondary efficacy, PK, safety, and immunogenicity up to wk. 52  

• Avtozma is a recombinant humanized mAb that targets the IL-6 receptor 

 

13. Sandoz Launches Pyzchiva (Biosimilar, Ustekinumab-ttwe) in the US for Chronic Inflammatory Diseases 

Company: Sandoz 

Product: Pyzchiva 

Active Ingredient: Ustekinumab-ttwe 

Reference Product: Stelara 

Reference Product Company: Johnson & Johnson 

Disease: Psoriatic Arthritis, Plaque Psoriasis, Crohn’s Disease, Ulcerative Colitis, and Pediatric Plaque Psoriasis & Psoriatic Arthritis 

Date:  Feb 24, 2025   

Shots: 

• Sandoz has launched Pyzchiva, a biosimilar version of Stelara in the US to treat mod. to sev. plaque PsO & active PsA in adults as well as pediatric pts, plus mod. to sev. active crohn’s disease & UC in adults; expected to offer interchangeability by H1'25 

• Launch follows Samsung’s settlement & license deal with J&J for the US market & commercialization agreement with Sandoz in Sep 2023. As per the Sep 2023 deal, Sandoz can market Pyzchiva in the US, Canada, EEA, Switzerland, UK & Brazil, while Samsung handles development, IP, manufacturing & supply 

• Pyzchiva is a fully human anti-IL-12/IL-23 mAb that is available in pre-filled syringes (45mg/0.5mL & 90mg/mL) & single-dose vials (IV: 130mg/26 mL & SC: 45mg/0.5 mL) 

 

14. Biocon Biologics Launches Yesintek (Biosimilar, Stelara) in the US  

Company: Biocon Biologics 

Product: Yesintek  

Active Ingredient: Ustekinumab- kfce 

Reference Product: Stelara 

Reference Product Company: Johnson & Johnson 

Disease: Psoriatic Arthritis, Plaque Psoriasis, Crohn’s Disease, Ulcerative Colitis, and Pediatric Plaque Psoriasis & Psoriatic Arthritis 

Date: Feb 24, 2025   

Shots: 

• Biocon Biologics has launched Yesintek (ustekinumab- kfce), a biosimilar to Stelara, to treat psoriatic arthritis, plaque psoriasis, Crohn’s disease, ulcerative colitis, pediatric plaque psoriasis, and pediatric psoriatic arthritis across the US. The available presentations are 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5 mL vial, and 130 mg/26 mL vial 

• The approval was supported by analytical, nonclinical & clinical data from a P-III (STELLAR-2) study of Yesafili vs Stelara in moderate-to-severe chronic Plaque Psoriasis, confirming its similarity in PK, safety, efficacy & immunogenicity 

• YESINTEK will have commercial payor coverage at launch and a comprehensive patient assistance program, including benefits verification and copay support. Eligible patients may pay as little as $0, with a copay program competitive to the originator's 

 

15. Formycon Reports the MHRA’s Approval of FYB203 (Biosimilar, Eylea) as Ahzantive 

Company: Teva Pharmaceuticals, Klinge Biopharma & Formycon 

Product: FYB203 (Under the brand name Ahzantive) 

Active Ingredient: Aflibercept 

Reference Product: Eylea 

Reference Product Company: Bayer 

Disease: Neovascular Age-Related Macular Degeneration (nAMD) & Other Retinal Diseases   

Date: Feb 25, 2025   

Shots: 

• Following the EC approval, Formycon & Klinge Biopharma have reported the UK MHRA’s approval of FYB203, biosimilar of Eylea (aflibercept), under the brand name: Ahzantive  

• The biosimilar is intended to treat Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), visual impairment due to Myopic Choroidal Neovascularization (CNV) & Macular Edema following Retinal Vein Occlusion (RVO) 

• Furthermore, Formycon & Teva Pharmaceuticals have partnered for the semi-exclusive commercialization of FYB203 in major parts of EU, including the UK & Israel. Formycon had concluded a product supply agreement with Teva, which is already marketing Formycon’s FYB201 ranibizumab biosimilar (Ongavia) in UK and will leverage its existing ophthalmology infrastructure and distribution channels 

 

Related Post: Key Biosimilars Events of January 2024