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
- Fresenius Kabi Secured the CHMP’s Positive Opinion for Bomyntra & Conexxence. Our team at PharmaShots has summarized 11 key events of the biosimilar space of May 2025
Company: Teva and Alvotech
Product: Selarsdi
Active Ingredient: Ustekinumab-aekn
Reference Product: Stelara
Reference Product Company: Johnson & Johnson
Disease: Psoriatic Arthritis, Plaque Psoriasis, Crohn’s Disease, Ulcerative Colitis, and Pediatric Plaque Psoriasis & Psoriatic Arthritis
Date: May 05, 2025
Shots:
- The US FDA has granted interchangeable designation to Selarsdi, a biosimilar version of Stelara (ustekinumab) for all indications incl. treatment of adult & pediatric PsA & plaque PsO as well as Crohn’s disease, & ulcerative colitis, effective as of Apr 30, 2025
- Selarsdi is an anti-IL-12/IL-23 mAb, with 4 approved doses & formulations: 45mg/0.5mL & 90mg/mL SC PFS, 45mg/0.5mL single-dose vials for SC, & 130mg/26mL single-dose IV infusion vials
- Additionally, the US FDA has accepted BLAs for 3 Alvotech-Teva biosimilars: AVT05, a biosimilar version of Simponi & Simponi Aria (golimumab) & AVT06, a biosimilar version of Eylea (aflibercept), with BsUFA goal dates in Q4’25
Company: Fresenius Kabi
Product: Otulfi
Active Ingredient: Ustekinumab- aauz
Reference Product: Stelara
Reference Product Company: Johnson & Johnson
Disease: Psoriatic Arthritis, Plaque Psoriasis, Crohn’s Disease, Ulcerative Colitis, and Pediatric Plaque Psoriasis & Psoriatic Arthritis
Date: May 19, 2025
Shots:
- The US FDA has granted interchangeable designation to Otulfi, a biosimilar version of Stelara (ustekinumab) to treat mod. to sev. active Crohn’s disease, ulcerative colitis, plaque PsO as well as active PsA, available in the US since Mar 2025
- FDA approval was granted in Sep 2024 based on analytical, pre-clinical, clinical & manufacturing data, showing similar efficacy, safety, PK & immunogenicity of Otulfi vs Stelara among mod. to sev. plaque PsO pts
- Fresenius Kabi holds exclusive marketing rights of Otulfi in key global markets, with semi-exclusive rights in Germany plus parts of MENA & LATAM as per an agreement signed in Feb 2023 with Formycon
Company: Sandoz
Product: Pyzchiva Autoinjector
Active Ingredient: Ustekinumab
Reference Product: Stelara
Reference Product Company: Johnson & Johnson
Disease: Psoriatic Arthritis, Plaque Psoriasis, Crohn’s Disease, Ulcerative Colitis, and Pediatric Plaque Psoriasis & Psoriatic Arthritis
Date: May 21, 2025
Shots:
- Sandoz has launched Pyzchiva autoinjectors, a biosimilar version of Stelara (ustekinumab) in EU to treat pts (≥6yrs.; ≥60kg) with plaque PsO, PsA, Crohn’s disease & pediatric plaque PsO; commercially available in Spain, with further expansion to continue
- In Sep 2023, Sandoz & Samsung Bioepis entered into a development & commercialization agreement, granting Sandoz rights to market Pyzchiva in Brazil, the US, the EEA, Switzerland & the UK, with Samsung handling development, registration, IP, manufacturing, & supply
- Pyzchiva is a fully human anti-IL-12/IL-23 mAb that is available in pre-filled pen for autoinjector (45mg/0.5mL & 90mg/1mL), single-dose vials (130mg) & pre-filled syringe (45mL)
Company: Fresenius Kabi
Product: Tyenne
Active Ingredient: Tocilizumab
Reference Product: Actemra
Reference Product Company: Roche
Disease: Mod. to Sev. Active Rheumatoid Arthritis, Giant Cell Arteritis, Polyarticular Juvenile Idiopathic Arthritis, Systemic Juvenile Idiopathic Arthritis, Cytokine Release Syndrome, and COVID-19
Date: May 21, 2025
Shots:
- Following the launch of Idacio (adalimumab) Citrate-free, Fresenius Kabi Canada has launched Tyenne (IV/SC), a biosimilar version of Actemra (tocilizumab) from Roche, now available in Canada
- Tyenne (IL-6 receptor blocker) is approved to treat inflammatory and immune conditions such as rheumatoid arthritis (RA), giant cell arteritis (GCA), Polyarticular juvenile idiopathic arthritis (pJIA), and systemic juvenile idiopathic arthritis (sJIA), cytokine release syndrome (CRS), and COVID-19
- Fresenius Kabi supports Tyenne patients in Canada through its KabiCare program
Company: Celltrion
Product: Yuflyma
Active Ingredient: Adalimumab-aaty
Reference Product: Humira
Reference Product Company: Abbvie
Disease: Rheumatoid arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, and Uveitis
Date: May 23, 2025
Shots:
- FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg) & autoinjectors (40 & 80mg) expanding on the prior designation for the 20mg & 80mg prefilled syringes
- The designation was based on P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. active plaque PsO receiving reference adalimumab (ADA) continuously or those who alternated between ADA & Yuflyma during Wk. 25-27; data was shared at EADV 2024
- Yuflyma is a high-concentration (100mg/mL), citrate-free formulation of Humira that will be available at a reduced WAC list price of $948/syringe, effective immediately
Company: Lupin & SteinCares
Product: Ranibizumab
Active Ingredient: Ranibizumab
Reference Product: Lucentis
Reference Product Company: Roche & Novartis
Disease: Neovascular Age-Related Macular Degeneration, Macular Edema Following RVO, Diabetic Macular Edema, Diabetic Retinopathy, Myopic Choroidal Neovascularization
Date: May 26, 2025
Shots:
- Lupin & SteinCares have entered into a license & supply agreement to commercialize Lupin’s ranibizumab biosimilar in Latin America excl. Mexico & Argentina
- As per the deal, SteinCares will be responsible for the biosimilar’s regulatory filings, registration, & commercialization in LATAM licensed states, while Lupin will oversee its manufacturing
- Ranibizumab is a recombinant humanized IgG1 mAb fragment that targets & inhibits VEGF-A for the treatment of wet age-related macular degeneration, retinal vein occlusion-related macular edema, diabetic macular edema, diabetic retinopathy, & myopic choroidal neovascularization
Company: mAbxience and Abiogen Pharma
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: N/A
Date: May 26, 2025
Shots:
- mAbxience, majority-owned by Fresenius Kabi and partially by Insud Pharma, has partnered with Abiogen Pharma in a strategic licensing agreement to develop & commercialize a biosimilar in Italy
- As per the agreement, mAbxience will hold marketing authorization, while Abiogen Pharma handles commercialization and marketing in Italy
- This collaboration leverages mAbxience’s biosimilar development expertise and Abiogen Pharma’s robust commercial footprint in the Italian market
Company: Bio-Thera Solutions & Hikma Pharmaceuticals
Product: Starjemza
Active Ingredient: Ustekinumab-hmny
Reference Product: Stelara
Reference Product Company: Johnson & Johnson
Disease: Psoriatic Arthritis, Plaque Psoriasis, Crohn’s Disease, Ulcerative Colitis, and Pediatric Plaque Psoriasis & Psoriatic Arthritis
Date: May 27, 2025
Shots:
- The US FDA has approved Starjemza (BAT2206), a biosimilar version of Stelara (ustekinumab) for all indications of the reference product
- Approval was based on comprehensive analytical, non-clinical, & clinical data incl. extensive analytical characterization, P-I trial in healthy subjects & P-III trial in mod. to sev. plaque PsO pts, showing similar efficacy, safety, PK & immunogenicity of Starjemza vs US & EU Stelara
- In Aug 2021, Bio-Thera & Hikma entered into a license & commercialization agreement, with Bio-Thera responsible for the development & manufacturing of Starjemza, & Hikma handling its commercialization in the US
Company: Samsung Bioepis and Organon
Product: Hadlima
Active Ingredient: Adalimumab-bwwd
Reference Product: Humira
Reference Product Company: AbbVie
Disease: Rheumatoid arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Crohn’s Disease, Ulcerative Colitis, Plaque Psoriasis, Hidradenitis Suppurativa, and Uveitis
Date: May 27, 2025
Shots:
- FDA has granted interchangeability designation to Hadlima, a biosimilar version of Humira (adalimumab) for prefilled syringe (40mg/0.4mL) & autoinjectors (40mg/0.4mL & 40mg/0.8mL) expanding on the prior designation for prefilled syringe (40mg/0.8mL) & single-dose vial
- Designation was based on trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. plaque PsO receiving Humira continuously or those who alternated between EU Humira & Hadlima; additional clinical data also supported the designation
- FDA approved Hadlima’s low-concentration (40mg/0.8mL) in 2019 while its high-concentration version (40mg/0.4mL) was approved in 2022, both as prefilled syringes & autoinjectors
Company: Fresenius kabi
Product: Bomyntra & Conexxence
Active Ingredient: Denosumab
Reference Product: Prolia and Xgeva
Reference Product Company: Bayer
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: May 27, 2025
Shots:
- The CHMP has recommended a positive opinion for the marketing authorization of Bomyntra and Conexxence, biosimilars of Bayer’s Xgeva and Prolia (denosumab). EC approval is anticipated in Q3’25
- The MAA submissions were based on comprehensive analytical similarity assessments and two comparative clinical studies: one on PK, PD, and immunogenicity in healthy volunteers, and another assessing efficacy, PD, safety, and immunogenicity in women with PMO
- The two applications cover all reference product indications, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of cancer-related bone complications, and giant cell tumors of the bone
Company: Alvotech and Advanz Pharma
Product: Ilaris & Kesimpta
Active Ingredient: Canakinumab & Ofatumumab
Reference Product: Ilaris & Kesimpta
Reference Product Company: Novartis
Disease: N/A
Date: May 28, 2025
Shots:
- Alvotech has entered into an agreement with Advanz Pharma to expand their commercial partnership to include 3 more biosimilar candidates
- As per the deal, Advanz will register & commercialize biosimilars of Ilaris (canakinumab), Kesimpta (ofatumumab), & an undisclosed biologic in the EU, while Alvotech will handle development & commercial supply; partners will share revenues, with Alvotech receiving ~$180M in development & commercial milestones
- In 2023, Alvotech & Advanz Pharma partnered to commercialize biosimilars of Xolair (AVT23), Simponi, Entyvio, Eylea, Eylea HD, Dupixent, Taltz, & Tremfya across the EEA, UK, & Switzerland, with AVT23’s agreement also covering Canada, Australia, & New Zealand
Note: The following biosimilar received the CHMP’s Positive Opinion. However, as of May 31, 2025, no PR was available:
- Rolcya (Biosimilar, Denosumab)
Related Post: Key Biosimilars Events of April 2025
