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Key Biosimilars Events of October 2024

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Key Biosimilars Events of October 2024

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 Dong-A ST’s Imuldosa for treating Plaque Psoriasis, Crohn's Disease, Psoriatic Arthritis & Ulcerative Colitis. Our team at PharmaShots has summarized 8 key events of the biosimilar space of October 2024 

 

1. Teva and mAbxience Join Forces on Second Biosimilar Candidate in Oncology 

Active Ingredient: N/A 

Date: Oct 03, 2024   

Product: N/A 

Reference Product: N/A 

Company: Teva and mAbxience 

Disease: Oncology 

Shots: 

  • Teva and mAbxience have entered into a second global licensing agreement to develop an anti PD-1 biosimilar candidate in oncology 
  • As per the agreement, mAbxience will employ its state-of-the-art, cGMP-compliant facilities in Spain and Argentina for the development & production of biosimilar while Teva will handle its regulatory approvals & commercialization 
  • The agreement will grant exclusive rights across the EU, US & other various regions, supporting mAbxience's global expansion 

 

2. Teva Reports the Acceptance of Regulatory Submissions for TVB-009P (Biosimilar, Prolia) by the US FDA and EMA 

Active Ingredient: Denosumab 

Date: Oct 08, 2024   

Product: TVB-009P 

Reference Product: Prolia 

Company: Teva Pharmaceutical 

Disease: Postmenopausal Osteoporosis 

Shots: 

  • The US FDA and the EMA has accepted Teva’s applications for TVB-009P, biosimilar version of Prolia (denosumab), for all the approved indications, with their decisions anticipated during H2’25 
  • Submissions were built upon the data from P-III (TVB009-IMB-30085) study assessing safety & efficacy of TVB-009P vs Prolia among women with postmenopausal osteoporosis as well as from PK/PD trial (TVB009-BE-10157) among healthy subjects showing similarity b/w the drugs 
  • TVB-009P is a monoclonal antibody that works by targeting RANKL which regulates bone metabolism and osteoclast formation 

 

3. Bio-Thera Collaborates with Gedeon Richter for BAT2206 (Biosimilar, Stelara) 

Active Ingredient: Ustekinumab 

Date: Oct 10, 2024   

Product: BAT2206 

Reference Product: Stelara 

Company: Bio-Thera and Gedeon Richter 

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

Shots: 

  • Bio-Thera has entered into an exclusive commercialization and licensing agreement with Gedeon Richter for BAT2206, a biosimilar version of Stelara (ustekinumab) 
  • Bio-Thera will handle development, manufacturing & supply of BAT2206 while Richter will have exclusive commercialization rights across the EU, UK, Switzerland & selected regions. Bio-Thera has already submitted regulatory filing with the EMA in Jul 2024 
  • Gedeon Richter will pay $8.5M upfront as well as ~$101.5M development & commercial milestones, contingent on meeting certain conditions 

 

4. Alvotech Reports the EMA’s Acceptance of MAA for AVT03 (Biosimilar, Prolia and Xgeva) 

Active Ingredient: Denosumab 

Date: Oct 10, 2024   

Product: AVT03 

Reference Product: Prolia & Xgeva 

Company: Alvotech 

Disease: Osteoporosis 

Shots: 

  • The EMA has accepted the marketing authorization application of AVT03, a biosimilar version of Prolia & Xgeva (denosumab) 
  • Submission was based on the AVT03-GL-C01 trial among postmenopausal women (n=532) with osteoporosis as well as AVT03-GL-P01 (n=209) & AVT03-GL-P03 (n=208) studies among healthy adults, depicting similarity in efficacy, safety, immunogenicity & PK b/w the drugs 
  • Additionally, Alvotech will develop & manufacture AVT03, while STADA & Dr. Reddy’s hold semi-exclusive rights to commercialize it in the EU, incl. Switzerland & UK 

 

5. Dong-A ST Reports the US FDA’s Approval of Imuldosa (Biosimilar, Stelara) 

Active Ingredient: Ustekinumab 

Date: Oct 11, 2024   

Product: Imuldosa 

Reference Product: Stelara 

Company: Dong-A ST 

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

Shots: 

  • Following the BLA submission by Accord BioPharma (Intas Pharmaceuticals’ subsidiary) in 2023, the US FDA has granted approval to Imuldosa, a biosimilar version of Stelara (ustekinumab). Its MAA has also been accepted by the EMA in 2023 
  • Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US, EU, UK & Canada while Meiji & Dong-A ST will provide Imuldosa for the same, as per an agreement b/w the companies signed in 2021 
  • Imuldosa (ustekinumab-srlf) is a recombinant mAb developed as an interchangeable for treating autoimmune and inflammatory diseases incl. plaque psoriasis, psoriatic arthritis, Crohn’s disease & ulcerative colitis 

 

6. Dong-A ST Receives the CHMP’s Positive Opinion for Imuldosa (Biosimilar, Stelara) 

Active Ingredient: Ustekinumab 

Date: Oct 21, 2024   

Product: Imuldosa 

Reference Product: Stelara 

Company: Dong-A ST 

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

Shots: 

  • Following the MAA submission by Accord Healthcare (Intas’ subsidiary) in 2023, the EMA’s CHMP has granted positive opinion to Imuldosa, a biosimilar version of Stelara (ustekinumab) 
  • Intas Pharmaceuticals with its subsidiaries (Accord BioPharma & Accord Healthcare) will commercialize the biosimilar across the US, EU, UK & Canada while Meiji & Dong-A ST will provide Imuldosa for the same, as per an agreement b/w the companies signed in 2021 
  • Imuldosa (ustekinumab-srlf) is a recombinant mAb developed as an interchangeable for treating autoimmune and inflammatory diseases incl. plaque psoriasis, psoriatic arthritis, Crohn’s disease & ulcerative colitis 

 

7. Alvotech and Teva Reports the US FDA’s Approval for the Additional Presentation of Selarsdi (Biosimilar, Stelara) 

Active Ingredient: Ustekinumab 

Date: Oct 22, 2024   

Product: Selarsdi 

Reference Product: Stelara 

Company: Alvotech and Teva 

Disease: Moderate to Severe Plaque Psoriasis & Active Psoriatic Arthritis 

Shots: 

  • Alvotech and Teva have received the US FDA’s approval of Selarsdi’s new dosing presentation of 130mg/26mL (5mg/mL) solution in a single-dose vial for IV infusion for the same indications as Stelara (ustekinumab). It will be launched in the US during Q1’25 
  • The US FDA, in Apr 2024, approved Selarsdi’s dosing of 45mg/0.5mL & 90mg/mL injection in a prefilled SC syringe to treat moderate to severe plaque psoriasis & active psoriatic arthritis among adults and pediatric (≥6yrs.) 
  • Both companies have entered into a settlement & license agreement with J&J (Stelara’s manufacturer) in Jun 2023 to market Selarsdi across the US in Feb 2025 

 

8. Meitheal Pharmaceuticals Receives Exclusive Commercial Rights of Three Biosimilars Across the US 

Active Ingredient: Pegfilgrastim, Filgrastim & Follitropin alpha 

Date: Oct 31, 2024   

Product: N/A 

Reference Product: Neulasta, Neupogen & Gonal-F 

Company: Meitheal Pharmaceuticals 

Disease: Oncology & Fertility Treatment 

Shots: 

  • Meitheal Pharmaceuticals & its parent, Hong Kong King-Friend Industry (HKF), have entered into an exclusive licensing agreement for commercializing biosimilars of pegfilgrastim & filgrastim in oncology and follitropin alpha for fertility treatment in the US 
  • Pegfilgrastim (SC, once per cycle) & filgrastim (SC, IV, daily for 14 days in CT treatment cycle) are bone marrow stimulants which enhance WBC production in cancer patients by binding to G-CSF receptors, stimulating neutrophil proliferation & activation against infection 
  • Follitropin alpha is a recombinant human follicle-stimulating hormone (FSH) used to promote follicle development in women & spermatogenesis in men during fertility treatments 

 

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

  • Absimky (Biosimilar, Stelara) 

 

Related Post: Insights+ Key Biosimilars Events of September 2024   


Dipanshu Dixit

A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies. He can be contacted at connect@pharmashots.com

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