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’ Epysqli for Treating Paroxysmal Nocturnal Hemoglobinuria (PNH) and CHMP’s Positive opinion of Fresenius Kabi and Formycon’s FYB202 for Treating Moderate to Severe Plaque PsO. Our team at PharmaShots has summarized 10 key events of the biosimilar space of July 2024 

1. Fresenius Kabi Introduces Tyenne (Biosimilar, Actemra) Across the US 

Active Ingredient: Tocilizumab-aazg 

Date:  July 02, 2024 

Product:  Tyenne 

Reference Product: Actemra 

Company: Fresenius Kabi 

Disease:  Autoimmune Diseases 

Shots:   

• The company has introduced SC formulation of Tyenne, a biosimilar of Actemra, to treat chronic autoimmune diseases across the US. It is available in the form of prefilled syringe & an autoinjector 

• The IV formulation of the biosimilar was introduced in Apr 2024 after the US FDA’s approval on Mar 05, 2024 

• Tyenne, an IL-6 receptor antagonist, is intended for the treatment of autoimmune diseases such as rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis & systemic juvenile idiopathic arthritis 

2. Just-Evotec Biologics and Sandoz Expand their Collaboration for Biosimilar  

Active Ingredient: N/A 

Date:  July 08, 2024 

Product:  N/A 

Reference Product: N/A 

Company: Just-Evotec Biologics and Sandoz 

Disease:  N/A 

Shots:   

• Just-Evotec Biologics (Evotec’s biologics segment) & Sandoz have expanded their tech collaboration to develop & manufacture biosimilars. They have been in a multi-year tech collaboration since May 2023 

• Under the agreement, Just-Evotec will get payment for early scientific validation along with additional funding tied to milestones from 2025 

• Through the expanded collaboration, Just-Evotec will provide biosimilar to Sandoz from its new J.POD facility. Sandoz further gets long-term supply guarantees with significant reserved manufacturing capacity 

3. Samsung Bioepis Reports the US FDA’s Approval of Epysqli (Biosimilar, Soliris) 

Active Ingredient: Eculizumab-aagh 

Date: July 19, 2024 

Product: Epysqli  

Reference Product: Soliris 

Company: Samsung Bioepis 

 Disease: Paroxysmal Nocturnal Hemoglobinuria (PNH) 

 Shots:   

• The US FDA has granted approval to the company’s BLA of Epysqli (eculizumab-aagh), a biosimilar version of Soliris (eculizumab) 

• Approval was supported by data from the P-I trial depicting similar PK/PD, safety, tolerability & immunogenicity profiles among healthy subjects and the P-III trial showing comparable efficacy, safety, PK & immunogenicity in PNH patients b/w Epysqli vs Soliris 

• Epysqli is intended for treating paroxysmal nocturnal hemoglobinuria (PNH) for reducing hemolysis and atypical hemolytic uremic syndrome (aHUS) for inhibiting complement-mediated thrombotic microangiopathy 

4. STADA and Alvotech Introduces Uzpruvo (Biosimilar, Stelara) Across the EU 

Active Ingredient: Ustekinumab 

Date: July 22, 2024 

Product:  Uzpruvo 

Reference Product: Stelara 

Company: STADA and Alvotech 

Disease: Gastroenterology, Dermatology and Rheumatology 

Shots:   

• The company has introduced Uzpruvo, biosimilar of Stelara (ustekinumab) across the EU to treat gastroenterology, dermatology & rheumatology indications. Uzpruvo is available in a pre-filled syringes with a thinner needle & is latex-free to avoid allergic reactions  

• Further EU launches are expected in the upcoming mos., pending national price approvals through a fully European supply chain 

• Uzpruvo was approved across the EU in Jan 2024 to treat adults with Crohn’s disease & psoriatic arthritis plus plaque psoriasis in adults & children (from 6yrs.) 

5. Bio-Thera Reports the Regulatory Filing Acceptance for BAT2206 (Biosimilar, Stelara) Across the US and EU 

Active Ingredient: Ustekinumab 

Date:  July 24, 2024 

Product:  BAT2206 

Reference Product: Stelara 

Company: Bio-Thera 

Disease: Moderate to Severe Plaque PsO 

Shots:   

• The US FDA and EMA have accepted the BLA & MAA of BAT2206 for treating moderate to severe plaque PsO in adults eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active ulcerative colitis. BLA in China is under review 

• The applications were supported by the data from P-I (US & EU) & P-III trials assessing equivalent efficacy, PK, safety & immunogenicity of BAT2206 vs Stelara among healthy subjects and patients with moderate to severe plaque PsO, respectively 

• BAT2206, a biosimilar version of Stelara (ustekinumab), is a human mAb that prevents the binding of shared p40 with IL-12Rβ1 receptor protein to inhibit the activity of human IL-12 and IL-23 

6. Bio-Thera Solutions Reports the Initiation of Combined P-I/P-III Study of BAT3306 (Biosimilar, Keytruda) 

Active Ingredient: Pembrolizumab 

Date:  July 25, 2024 

Product:  BAT3306 

Reference Product: Keytruda 

Company: Bio-Thera 

Disease:  Non-squamous Non-small Cell Lung Cancer 

Shots:   

• Bio-Thera Solutions has commenced the patients dosing under the combined P-I/P-III study evaluating BAT3306, a biosimilar version of Keytruda (pembrolizumab) 

• The trial aims at assessing PK profile, safety & efficacy of BAT3306 vs Keytruda among patients (n=676) with non-squamous non-small cell lung cancer (nsNSCLC) 

• In addition, the company is also developing biosimilars of golimumab, secukinumab & mepolizumab plus includes BAT1806 (biosimilar of tocilizumab), approved by the US FDA, EMA & NMPA, BAT1706 (biosimilar of bevacizumab), approved by the US FDA & NMPA as well as BAT2206 (biosimilar of ustekinumab), filed with the US FDA, EMA & NMPA 

7. Fresenius Kabi and Formycon Report the CHMP’s Positive Opinion of FYB202 (Biosimilar, Stelara) 

Active Ingredient: Ustekinumab 

Date:  July 26, 2024 

Product:  Otulfi (Fresenius Kabi), Fymskina (Formycon) 

Reference Product: Stelara 

Company: Fresenius Kabi and Formycon 

Disease:  Moderate to Severe Plaque PsO 

Shots:   

• The CHMP has granted a positive opinion to Fresenius & Formycon’s FYB202, a biosimilar version of Stelara (ustekinumab), with the decision anticipated during Q4’24 

• The opinion was supported by non-clinical & clinical studies plus manufacturing data, depicting similar effectiveness, safety & PK profile of FYB202 vs Stelara among moderate to severe psoriasis vulgaris (plaque psoriasis) patients 

• FYB202, a human mAb, works by targeting cytokines interleukin-12 & interleukin-23. It is intended for serious inflammatory diseases in the areas of gastroenterology, dermatology & rheumatology 

8. Prestige Biopharma Reports the CHMP’s Positive Opinion of Tuznue (Biosimilar, Herceptin) 

Active Ingredient: Trastuzumab 

Date:  July 26, 2024 

Product:  Tuznue 

Reference Product: Herceptin 

Company: Prestige Biopharma 

Disease: Breast and Gastric Cancer 

Shots:   

• The CHMP has granted positive opinion to Tuznue, a biosimilar version of Herceptin (trastuzumab) for the treatment of HER2+ve early & metastatic breast cancer as well as HER2+ve metastatic gastric cancer 

• The recommendation was supported by the data showing similarity b/w Tuznue vs Herceptin under P-I & P-III trials to evaluate the PK profile, safety & immunogenicity among healthy volunteers & HER2+ve early breast cancer patients, respectively 

• In addition, Prestige has already entered into licensing agreements with Dr. Reddy’s, Tabuk, Cipla & Pharmapark for its marketing & sales worldwide, triggering milestone payments; negotiations are ongoing for market entry across the EU 

9. Bio-Thera Reports the EMA’s Approval of Avzivi (Biosimilar, Avastin) for Treating Multiple Indications 

Active Ingredient: Bevacizumab 

Date:  July 26, 2024 

Product:  Avzivi 

Reference Product: Avastin 

Company: Bio-Thera 

Disease: Multiple Indications of Avastin 

Shots:   

• The EMA has granted approval to the company’s Avzivi (bevacizumab), a biosimilar version of Avastin. Sandoz is responsible for marketing the drug across the EU 

• The license and commercialization agreement b/w Bio-Thera and Sandoz was signed in Sep 2021, under which Bio-Thera had the development and manufacturing rights while Sandoz secured the commercialization rights worldwide 

• Avzivi is a humanized mAb that works by inhibiting the binding of VEGF with its receptors to reduces neovascularization & induce blood vessels degradation, inhibiting tumor growth 

10. Dr. Reddy’s Ituxredi (Biosimilar, MabThera) Receives the CHMP’s Positive Opinion 

Active Ingredient: Rituximab 

Date:  July 29, 20249 

Product:  DRL_RI (Ituxredi)  

Reference Product: MabThera 

Company: Dr. Reddy’s Laboratories 

Disease: Multiple Indications  

Shots:   

• The CHMP has granted a positive opinion to DRL_RI (Ituxredi), a biosimilar of MabThera (rituximab) 

• The approval, if granted, would be applicable across the whole EU plus Norway, Iceland & Liechtenstein. A separate MAA will be submitted to the MHRA as per reliance route under the IRP 

• Ituxredi (CD20 directed cytolytic Ab) is for the treatment of Non-Hodgkin’s Lymphoma (NHL), Chronic Lymphocytic Leukaemia (CLL), Rheumatoid Arthritis (RA), Granulomatosis with Polyangiitis (GPA) & Microscopic Polyangiitis (MPA) as well as Pemphigus Vulgaris (PV) 

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

• Eksunbi (Biosimilar, Stelara) 

• Ranibizumab Midas (Biosimilar, Lucentis) 

Related Post: Insights+ Key Biosimilars Events of June 2024