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: