Key Biosimilars Events of October 2024
Shots:
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Biosimilars are developed to be highly similar versions of approved biologics in terms of safety, purity, and potency
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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
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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
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
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:
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Absimky (Biosimilar, Stelara)
Related Post: Insights+ Key Biosimilars Events of September 2024
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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