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 NMPA’s approval of Simcere Zaiming’s Enlituo for Treating metastatic colorectal cancer (mCRC) and EC’s Approval of Biogen’s Tofidence for Treating Arthritis & COVID-19. Our team at PharmaShots has summarized 9 key events of the biosimilar space of June 2024 

1. Bio-Thera Gains the CHMP’s Positive Opinion of Avzivi (Biosimilar, Avastin)  

Active Ingredient: Bevacizumab 

Date: June 03, 2024   

Product:  Avzivi  

Reference Product: Avastin 

Company: Bio-Thera 

Disease: Colorectal cancer 

Shots: 

• The CHMP has granted a positive opinion to the company’s Avzivi (bevacizumab), a biosimilar of Avastin to treat metastatic colorectal cancer 

• The opinion was based on a P-I study assessing the PK, safety & immunogenicity of Avzivi vs EU & US reference product among healthy subjects & a P-III confirmatory trial of Avzivi vs Avastin among advanced non-squamous NSCLC patients, Results showed similarity b/w the products 

• Under the license agreement of 2021, Bio-Thera will develop and manufacture Avzivi, while Sandoz has commercial rights in US, EU, Canada & selected regions 

2. Alvotech and STADA Extend their Strategic Partnership Covering AVT03 (Biosimilar, Denosumab) 

Active Ingredient: Denosumab 

Date: June 03, 2024   

Product:  AVT03  

Reference Product: Prolia/Xgeva 

Company: Alvotech & STADA 

Disease: Osteoporosis & Cancer-related Bone Loss 

Shots: 

• Alvotech & STADA expand their strategic collaboration covering AVT03, biosimilar of Prolia/Xgeva (denosumab), to treat osteoporosis & cancer-related bone loss, respectively 

• As per the agreement, AVT03 will be developed & manufactured by Alvotech at its state-of-the-art facility while STADA becomes marketing authorization holder with semi-exclusive commercial rights across the EU, incl. Switzerland & the UK and exclusive rights in certain countries across Central Asia & the Middle East 

• Furthermore, STADA gets commercial rights to the biosimilars of Humira & Stelara across Commonwealth of Independent States (CIS) countries in Central Asia while Alvotech reclaims commercial rights of AVT06, biosimilar of Eylea, from STADA 

3. Alvotech and Advanz Pharma Team Up to Commercialize AVT06/AVT29 (Biosimilar, Eylea) in Europe 

Active Ingredient: Aflibercept 

Date: June 03, 2024   

Product: AVT06/AVT29 

Reference Product: Eylea 

Company: Alvotech and Advanz Pharma 

Disease: Eye Disorders 

Shots: 

• Alvotech has signed an exclusive partnership agreement with Advanz Pharma to supply and commercialize AVT06 (2mg, Low dose) and AVT29 (8mg, High dose), biosimilars of Eylea 

• As per the agreement, Alvotech will develop & supply the biosimilars and receive an upfront plus subsequent development & commercialization milestones. Advanz Pharma will handle registration & commercialization, with exclusive rights in EU (semi-exclusive in Germany & France) 

• AVT06/AVT29 is a VEGF targeting recombinant fusion protein. The equivalence of AVT06 vs Eylea in patients with neovascular (wet) AMD was demonstrated in the study assessing its efficacy, safety and immunogenicity 

4. The EC Approves Biogen’s Tofidence (Biosimilar, Roactemra) for Treating Arthritis and COVID-19 

Active Ingredient: Tocilizumab 

Date: June 24, 2024   

Product: Tofidence  

Reference Product: Roactemra 

Company: Biogen 

Disease: Rheumatoid Arthritis & COVID-19 

Shots: 

• The EC has approved Tofidence (IV), a biosimilar version of Roactemra, to treat moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19 

• The approval was based on clinical data showing the similarity of Tofidence vs Roactemra evaluated under the P-I study among healthy participants and P-III trial among individuals with rheumatoid arthritis inadequately controlled by methotrexate 

• Additionally, Biogen is responsible for the commercialization of Tofidence across the globe excl. China (incl. Hong Kong, Macau and Taiwan) as per an agreement between Biogen and Bio-Thera signed in Apr 2021 

5. The NMPA Approves Simcere Zaiming’s Enlituo (Biosimilar, Cetuximab Beta) as a 1L Treatment for Metastatic Colorectal Cancer (mCRC) 

Active Ingredient: Cetuximab Beta 

Date: June 26, 2024   

Product: Enlituo  

Reference Product: Cetuximab Beta 

Company: Simcere Zaiming 

Disease: Metastatic Colorectal Cancer 

Shots: 

• The NMPA has approved Enlituo + CT (FOLFIRI), a biosimilar version of cetuximab beta, as a 1L treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC) 

• The approval was based on a P-II/III trial (n=505) evaluating cetuximab beta + CT vs CT, showing a PFS of 13.133mos. vs 9.567mos., an ORR of 69.1% vs 42.3% & OS of 2.322yrs. vs 1.900yrs. & a P-III confirmatory trial 

• Enlituo (CMAB009), a recombinant EGFR mAb developed in partnership with Mabpharm, is categorized as a 2.4 class modified biologic & is produced by utilizing a protein production technology that prevents glycosylation modification which results in hypersensitivity 

6. Coherus Reports the Divestment of Yusimry (Biosimilar, Humira) to Hong Kong King-Friend Industry 

Active Ingredient: Adalimumab-aqvh 

Date: June 27, 2024   

Product: Yusimry 

Reference Product: Humira 

Company: Coherus and Meitheal Pharmaceuticals 

Disease: All Indications of Humira 

Shots: 

• Coherus has divested Yusimry under an asset purchase agreement to Hong Kong King-Friend Industry (HKF) granting it global rights & all relevant assets of Yusimry such as its development & regulatory outcomes for $40M upfront 

• HKF has further granted the US commercial rights of the asset to Meitheal Pharmaceuticals (its subsidiary) under an exclusive license & supply agreement. Both the agreements will be effective, pending standard conditions & approvals 

• Meitheal will develop pediatric presentations & a high-concentration (100mg/mL) formulation of Yusimry (available in prefilled syringe & autoinjector forms), with its approvals in other indications & formulation anticipated in 2025 

7. Samsung Bioepis Reports the US FDA’s Approval of Pyzchiva (Biosimilar, Stelara) 

Active Ingredient: Ustekinumab-ttwe 

Date: June 28, 2024   

Product: Pyzchiva 

Reference Product: Stelara 

Company: Samsung Bioepis 

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

Shots: 

• The US FDA has approved Pyzchiva, a biosimilar of Stelara (ustekinumab), for treating moderate to severe plaque PsO patients eligible for phototherapy or systemic therapy, active PsA, moderate to severe active CD & moderate to severe active UC 

• Approval was based on studies of Pyzchiva vs Stelara incl. P-I, showing similarity in PK, safety, tolerability & immunogenicity among healthy subjects & P-III, depicting the similarity in moderate to severe plaque PsO patients at 28wks. 

• Pyzchiva, developed by Samsung, will be commercialized by Sandoz in the US as per an agreement signed in 2023 covering the US, Canada, EEA, Switzerland & UK. The license period will start on Feb 22, 2025 in the US, as per the settlement with Janssen 

8. Formycon and Klinge Biopharma Reports the US FDA’s Approval of Ahzantive (Biosimilar, Eylea) 

Active Ingredient: Aflibercept-mrbb 

Date: June 28, 2024 

Product: Ahzantive 

Reference Product: Eylea 

Company: Formycon and Klinge Biopharma 

Disease: Age-Related Neovascular Macular Degeneration and Other Serious Retinal Diseases 

Shots: 

• The US FDA has approved Formycon and Klinge Biopharma’s Ahzantive (aflibercept-mrbb), biosimilar of Eylea, for treating Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases incl. Diabetic Macular Edema (DME), Diabetic Retinopathy (DR) and Macular Edema following Retinal Vein Occlusion (RVO) 

• The approval was based on analytical, pre-clinical, clinical and manufacturing data shown similar efficacy, safety, PK & immunogenicity in Age-Related Neovascular (wet) Macular Degeneration (nAMD) patients 

• MAA was also submitted to the EMA in 2023, the decision of which is anticipated in early 2025 

9. Tanvex BioPharma Reports the US FDA’s Approval of Nypozi (Biosimilar, Neupogen) 

Active Ingredient: Filgrastim-txid 

Date: June 28, 2024 

Product: Nypozi 

Reference Product: Neupogen 

Company: Tanvex BioPharma 

Disease: Infections associated with Non-Myeloid Malignancies 

Shots: 

• The US FDA has granted BLA approval of Nypozi (TX01), biosimilar version of Amgen’s Neupogen 

• Nypozi (TX01) is intended to reduce the incidence of infection among patients having non-myeloid malignancies undergoing chemotherapy that may reduce neutrophil count 

• The company’s Nypozi was introduced across Canada in Jan 2024 

Related Post: Insights+ Key Biosimilars Events of May 2024