Shots:
- Biosimilars are developed to be highly similar 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
- Alvotech and Advanz Pharma Receive the EC’s Approval for Mynzepli (Biosimilar, Eylea). Our team at PharmaShots has summarized 11 key events of the biosimilar space of August 2025
Company: CivicaScript
Product: Ustekinumab-aauz
Active Ingredient: Ustekinumab-aauz
Reference Product: Stelara
Reference Product Company: Johnson and Johnson
Disease: Moderate to Severe Plaque Psoriasis, Active ulcerative Colitis & Active Crohn’s Disease, and Active Psoriatic Arthritis
Date: Aug 05, 2025
Shots:
- CivicaScript announced plans to distribute the biosimilar ustekinumab-aauz for CICs incl. plaque PsO, PsA, Crohn’s disease, and ulcerative colitis, with its launch anticipated on Jan 01, 2026
- Ustekinumab-aauz targets IL-12 & 23, helping regulate immune and inflammatory responses. Produced by Fresenius Kabi, it will be exclusively distributed by CivicaScript in the US and is interchangeable with Stelara for SC or IV use
- CivicaScript will offer ustekinumab-aauz in two PFS strengths: 90 mg (12-week supply) at $985 and 45 mg at $575 (WAC)
Company: Polpharma Biologics and Fresenius Kabi
Product: PB016
Active Ingredient: Vedolizumab
Reference Product: Entyvio
Reference Product Company: Takeda
Disease: Moderate to Severe Ulcerative Colitis & Crohn’s Disease
Date: Aug 05, 2025
Shots:
- Polpharma has entered into a global licensing agreement with Fresenius Kabi to commercialize PB016, a biosimilar of Takeda’s Entyvio (vedolizumab) for the treatment of mod. to sev. ulcerative colitis & Crohn’s disease
- As per the deal, Fresenius will obtain global commercialization rights to PB016, excl. Middle East & North Africa, while Polpharma will handle development & manufacturing
- Vedolizumab targets α4β7 integrin to block its interaction with MAdCAM-1 for producing anti-inflammatory effect
Company: Intas Pharmaceuticals and Coherus BioSciences
Product: Udenyca
Active Ingredient: Pegfilgrastim
Reference Product: Neulasta
Reference Product Company: Amgen
Disease: Non-myeloid Cancers Undergoing Myelosuppressive Chemotherapy, Improve Survival After Acute Radiation Exposure (Hematopoietic Subsyndrome of ARS)
Date: Aug 06, 2025
Shots:
- Intas Pharmaceuticals, through its Accord subsidiaries, has completed the acquisition of Coherus BioSciences’ Udenyca (pegfilgrastim-cbqv), a biosimilar of Neulasta
- With the acquisition, Accord BioPharma, Intas’ U.S. specialty arm, continues Udenyca commercialization, offering patient-friendly administration options autoinjector (AI), on-body injector (OBI), and prefilled syringe (PFS)
- Udenyca is a leukocyte growth factor used to reduce infection risk in patients with non-myeloid cancers undergoing myelosuppressive chemotherapy and to improve survival after acute radiation exposure (Hematopoietic Subsyndrome of ARS)
Company: Kashiv BioSciences and MS Pharma
Product: ADL-018
Active Ingredient: Omalizumab
Reference Product: Xolair
Reference Product Company: Genentech and Novartis
Disease: Moderate to severe persistent asthma, Chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and Chronic spontaneous urticaria
Date: Aug 05, 2025
Shots:
- Kashiv BioSciences and MS Pharma have signed a license & supply agreement for ADL-018, a Xolair (omalizumab) biosimilar, across the Middle East and North Africa (MENA) region, with anticipated regulatory submissions in Q4’25
- Under the agreement, Kashiv BioSciences will develop ADL-018, while MS Pharma will handle licensing, distribution, and commercialization in MENA, with local manufacturing at its Saudi Arabia biologics facility
- ADL-018 (omalizumab), a mAb targeting IgE. Xolair is approved for treating Chronic Idiopathic Urticaria (CIU) or Chronic Spontaneous Urticaria (CSU), severe persistent allergic asthma, chronic rhinosinusitis with nasal polyps (CRSwNP), and IgE-mediated food allergy
Company: Celltrion
Product: Avtozma
Active Ingredient: Tocilizumab
Reference Product: Actemra
Reference Product Company: Genentech
Disease: Rheumatoid Arthritis, Giant Cell Arteritis, Systemic Sclerosis-Associated Interstitial Lung Disease, Polyarticular Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis, Cytokine Release Syndrome, and COVID-19
Date: Aug 07, 2025
Shots:
- The US FDA has approved Avtozma IV, a biosimilar to Actemra (tocilizumab), for treating cytokine release syndrome in pts (≥2yrs.), covering all Actemra IV-approved indications in the US; expected to be available in the US by Aug 31, 2025
- In Jan 2025, the US FDA approved Avtozma IV to treat rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) & COVID-19
- Additionally, Celltrion holds the commercialization rights of the Avtozma SC formulation in the US, with the licensed launch date remaining confidential
Company: Lupin and Sandoz
Product: N/A
Active Ingredient: Ranibizumab
Reference Product: Lucentis
Reference Product Company: Genentech
Disease: Neovascular (Wet) Age-Related Macular Degeneration, Macular Edema Following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy, and Myopic Choroidal Neovascularization
Date: Aug 12, 2025
Shots:
- Lupin has entered into a licensing agreement with Sandoz to market & commercialize Lupin’s ranibizumab biosimilar in multiple regions
- As per the deal, Sandoz will commercialize the product in the EU (excl. Germany), Switzerland, Norway, Australia, Hong Kong, Vietnam, & Malaysia, while holding exclusive rights in most markets & semi-exclusive rights in France, Australia, Vietnam, & Malaysia, with Lupin handling manufacturing & regulatory filings
- Sandoz will acquire exclusive Canadian commercialization rights for Lupin’s biosimilar ranibizumab, under another agreement between the companies, with Lupin responsible for manufacturing & regulatory filings
Company: Accord BioPharma
Product: Imuldosa
Active Ingredient: Ustekinumab-srlf
Reference Product: Stelara
Reference Product Company: Johnson and Johnson
Disease: Moderate to Severe Plaque Psoriasis, Active ulcerative Colitis & Active Crohn’s Disease, and Active Psoriatic Arthritis
Date: Aug 18, 2025
Shots:
- Accord BioPharma, a division of Intas Pharmaceuticals, has launched Imuldosa (ustekinumab-srlf), a biosimilar to Stelara
- The launch includes a $0 co-pay program for eligible pts with plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis
- Through an exclusive deal with Bio-Thera Solutions, Accord plans to introduce BAT2506, a biosimilar to Simponi, to the U.S. market and has submitted multiple biosimilar applications to the FDA
Company: Alvotech and Advanz Pharma
Product: Mynzepli
Active Ingredient: Aflibercept
Reference Product: Eylea
Reference Product Company: Bayer and Regeneron
Disease: Neovascular (Wet) Age-Related Macular Degeneration, Macular Edema Following Retinal Vein Occlusion, Diabetic Macular Edema, Diabetic Retinopathy, and Retinopathy of Prematurity
Date: Aug 21, 2025
Shots:
- The EC has approved Mynzepli (AVT06), a biosimilar of Eylea (aflibercept) for all indications of the reference product in all 30 EEA states; AVT06’s Dossiers are under review in multiple regions incl. the US & Japan
- Approval was based on extensive analytical, non-clinical & clinical data incl. a confirmatory study assessing Mynzepli vs Eylea in neovascular AMD, which met its 1EP, showing similar efficacy, safety, & immunogenicity between the two.
- Mynzepli targets VEGF to inhibit receptor activation, neovascularization, & vascular permeability, which is available as a 40mg/mL solution for injection in a pre-filled syringe & a vial
Company: Bio-Thera Solutions and STADA
Product: BAT1806
Active Ingredient: Tocilizumab
Reference Product: RoActemra
Reference Product Company: Roche
Disease: Rheumatoid Arthritis, Polyarticular Juvenile Idiopathic Arthritis, COVID-19, Systemic Juvenile Idiopathic Arthritis, Giant Cell Arteritis, and CAR-T Cell-induced Cytokine Release Syndrome
Date: Aug 22, 2025
Shots:
- Bio-Thera & STADA have expanded their partnership to BAT1806, a biosimilar of Roche’s RoActemra (tocilizumab), whose 20mg/ml vial formulation received EMA’s approval in Jun 2024 for several arthritic conditions
- As per the deal, STADA will obtain exclusive rights to commercialize BAT1806 in the EU, UK, Switzerland & select other countries under its own marketing authorization while Bio-Thera will develop, manufacture, & supply BAT1806
- Collaboration expanded on Bio-Thera & STADA’s 2024 deal, which granted STADA exclusive regulatory & commercial rights to BAT2506 (Biosimilar, Simponi; MAA under EMA’s review) in mentioned regions, while Bio-Thera handled its development, manufacturing, & supply
Company: Bio-Thera Solutions
Product: Usymro
Active Ingredient: Ustekinumab
Reference Product: Stelara
Reference Product Company: Johnson and Johnson
Disease: Moderate to Severe Plaque Psoriasis, Active ulcerative Colitis & Active Crohn’s Disease, and Active Psoriatic Arthritis
Date: Aug 26, 2025
Shots:
- The EC has approved Usymro (BAT2206), a biosimilar of J&J’s Stelara (ustekinumab) for all indications of the reference product
- In Oct 2024, Bio-Thera & Gedeon Richter entered a licensing & commercialization deal under which Bio-Thera will develop & manufacture Usymro, while Gedeon will commercialize it post-approval & MA Holder transfer in the EU, UK, & Switzerland
- Ustekinumab is a fully human anti-IL-12/IL-23 mAb indicated for the treatment of autoimmune diseases incl. plaque psoriasis, psoriatic arthritis & Crohn’s disease
Company: Abbott
Product: Denosumab
Active Ingredient: Denosumab
Reference Product: Denosumab
Reference Product Company: Amgen
Disease: Osteoporosis And Cancer-related Bone Loss
Date: Aug 26, 2025
Shots:
- Abbott has secured regulatory approval for its denosumab biosimilar in Thailand, increasing access to advanced treatments for osteoporosis and cancer-related bone loss
- Denosumab is a mAb that works by targeting RANKL, which regulates bone metabolism & osteoclast formation
- Abbott will offer denosumab as part of its strategy to expand access to quality medicines in oncology, immunology, and women’s health through partnerships with biotech companies
Related Post: Key Biosimilars Events of July 2025
