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       
• The major highlights were the US FDA’s approval of Samsung Bioepis and Biogen’s Opuviz for treating wet AMD, visual impairment from macular edema due to RVO, DME & myopic CNV. Our team at PharmaShots has summarized 7 key events of the biosimilar space of September 2024 

1. The NMPA Clears Shanghai Henlius’ IND Application of HLX17 (Biosimilar, Keytuda) for Treating Solid Tumors 

Active Ingredient: Pembrolizumab 

Date: Sep 02, 2024   

Product: HLX17 

Reference Product: Keytruda 

Company: Shanghai Henlius 

Disease: Solid Tumors   

Shots: 

• The NMPA has cleared IND application of HLX17 to conduct its clinical study in comparison with Keytruda for treating melanoma, NSCLC, esophageal cancer, HNSCC, CRC, HCC, biliary tract cancer, TNBC, MSI-H/dMMR cancer & gastric cancer  
• HLX17 was assessed under pharmacologic comparative trial, preclinical pharmacology study as well as PK/PD & immunogenicity studies that showed similarity b/w the two drugs 
• HLX17 (mAb) works by binding with PD-1 receptor to prevent its interaction with PD-L1 & PD-L2, restoring T-cell immune surveillance and enhancing anti-tumor activity 

2. Accord BioPharma’s Hercessi 420mg (Biosimilar, Herceptin) Receives the US FDA’s Approval to Treat Various HER2-Overexpressing Cancer 

Active Ingredient: Trastuzumab 

Date: Sep 18, 2024    

Product: Hercessi 

Reference Product: Herceptin 

Company: Accord BioPharma 

Disease: Breast & G/GEJ Adenocarcinoma 

Shots: 

• The US FDA has granted approval to the company’s Hercessi (420mg), a biosimilar version of Herceptin (trastuzumab), for the treatment of HER2-overexpressing breast & G/GEJ adenocarcinoma. It is planned to be introduced in early 2025 
• The approval was supported by the analytical, preclinical & clinical data showing similarity b/w Hercessi & Herceptin from the studies incl. P-I (HLX02-HV01 & 2) PK trials in healthy volunteers & a P-III (HLX02-BC01) trial with docetaxel in patients with HER2+ metastatic breast cancer 
• Hercessi was developed by Shanghai Henlius Biotech. Accord BioPharma secured its exclusive development & commercialization rights across the US & Canada in 2021 

3. The CHMP Grants Positive Opinion to Samsung Bioepis and Biogen’s Opuviz (Biosimilar, Eylea) 

Active Ingredient: Aflibercept 

Date: Sep 20, 2024    

Product: Opuviz 

Reference Product: Eylea 

Company: Samsung Bioepis and Biogen 

Disease: Wet AMD & Visual impairment from macular edema due to RVO            

Shots: 

• The CHMP has granted positive opinion to Opuviz (40mg/mL), a biosimilar to Eylea (aflibercept), for treating wet AMD, visual impairment from macular edema due to RVO, DME & myopic CNV 
• The opinion was based on P-III trial in treatment-naïve nAMD patients (n=449), to receive either Opuviz or Eylea & switching b/w the treatments at wk.32. By wk.56, 425 patients completed the study 
• The study showed similar efficacy, safety, immunogenicity & PK profile b/w Opuviz vs Eylea. It reached the 1EPs of BCVA improvement at wk.8 as well as 2EPs at wks.32 & 56 confirming the similarity b/w both the drugs 

4. Alvotech Reports the Initiation of Confirmatory Trial of AVT16 (Biosimilar, Entyvio) 

Active Ingredient: Vedolizumab 

Date: Sep 25, 2024    

Product: AVT16 

Reference Product: Entyvio 

Company: Alvotech 

Disease: Ulcerative Colitis 

Shots: 

• Alvotech has begun the confirmatory trial of AVT16, biosimilar version of Entyvio (vedolizumab), that targets alpha-4-beta-7 protein for treating Ulcerative Colitis and Crohn’s disease 
• The P-III (AVT16-GL-C01) trial is a double-blind, two-arm study comparing the efficacy, safety & immunogenicity of AVT16 vs Entyvio in patients of age 18-80yrs. with moderate to severe active Ulcerative Colitis 
• Alvotech's biosimilars portfolio targets autoimmune, eye, bone, respiratory diseases, and cancer. The company plans marketing applications for 3 biosimilars in 2024, with AVT16 among 6 earlier-stage programs 

5. Formycon and Fresenius Kabi Reports the EC’s Approval of Otulfi (Biosimilar, Stelara) for Serious Inflammatory Diseases 

Active Ingredient: Ustekinumab 

Date: Sep 27, 2024    

Product: Otulfi 

Reference Product: Stelara 

Company: Formycon and Fresenius Kabi 

Disease: Crohn’s disease, Plaque Psoriasis, and Active Psoriatic Arthritis 

Shots: 

• The EC has approved Otulfi (IV/SC), a biosimilar of Stelara (ustekinumab), to treat mod. to sev. active CD, mod. to sev. plaque PsO & active PsA, valid across EU as well as Iceland, Liechtenstein & Norway 
• Approval was based on analytical, pre-clinical, clinical & manufacturing data, depicting similar effectiveness, safety & PK profile of Otulfi vs Stelara in mod. to sev. psoriasis vulgaris patients 
• Additionally, Fresenius Kabi holds exclusive commercialization rights of Otulfi in key global markets, with semi-exclusive rights in Germany plus parts of MENA & LATAM. Formycon got upfront & is eligible for milestones, with both companies equally sharing post-commercialization value as per an agreement signed in Feb 2023 

6. Organon and Shanghai Henlius Biotech Provides Update on P-III Trial of HLX11 (Biosimilar, Perjeta) 

Active Ingredient: Pertuzumab 

Date: Sep 30, 2024    

Product: HLX11 

Reference Product: Perjeta 

Company: Organon and Shanghai Henlius 

Disease: Breast Cancer 

Shots: 

• The P-III study assessing safety & efficacy of HLX11 vs Perjeta (pertuzumab) in addition to trastuzumab & docetaxel (Q3W, 4 cycles) as a neoadjuvant regimen for treating patients, randomized 1:1, with HER2+/HR- locally advanced breast cancer has reached the 1EP 
• The 1EP of the trial includes total pathological complete response (tpCR) rate as per IRC while the 2EPs are tpCR rate assessed by investigators, breast pathologic complete response (bpCR) rate, ORR, EFS, DFS, safety, PK & immunogenicity 
• Additionally, Henlius granted Organon exclusive global commercialization rights (excl. China) for two biosimilar candidates, incl. HLX11, as per a license and supply agreement signed in 2022 

7. Fresenius Kabi and Formycon Report the US FDA’s Approval of Otulfi (Biosimilar, Stelara) 

Active Ingredient: Ustekinumab 

Date: Sep 30, 2024    

Product: Otulfi 

Reference Product: Stelara 

Company: Formycon and Fresenius Kabi 

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

Shots: 

• The US FDA has approved Otulfi (SC & IV), biosimilar of Stelara (ustekinumab), to treat Crohn’s disease, ulcerative colitis, mod. to sev. plaque PsO & active psoriatic arthritis. Fresenius Kabi can market Otulfi by Feb 22, 2025 
• Approval was based on analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity of Otulfi vs Stelara among mod. to sev. psoriasis vulgaris patients 
• Additionally, Fresenius Kabi holds exclusive commercialization rights of Otulfi in key global markets, with semi-exclusive rights in Germany plus parts of MENA & LATAM. Formycon got upfront & is eligible for milestones, with both companies equally sharing post-commercialization value as per an agreement signed in Feb 2023 

Note: The following biosimilar received the CHMP’s Positive Opinion. However, as of September 31, 2024, no PR was available:  

• Afqlir (Biosimilar, Eylea) 

Related Post: Insights+ Key Biosimilars Events of August 2024