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
- Henlius Collaborates with Sandoz for the Commercialization of HLX13. Our team at PharmaShots has summarized 13 key events of the biosimilar space of March 2025
Company: Organon & Biogen
Product: Tofidence
Active Ingredient: Tocilizumab-bavi
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, and COVID-19.
Date: Apr 01, 2025
Shots:
- Organon has acquired the US regulatory & commercial rights for Tofidence, a biosimilar version of Actemra (tocilizumab), from Biogen, which retains manufacturing rights in the US
- As per the deal, Biogen will receive upfront, while Organon will assume Biogen’s obligation to pay Bio-Thera tiered annual net sales royalties & milestones
- Tofidence is a humanized anti-IL-6 mAb that will be available in 3 vial sizes—80mg/4mL, 200mg/10mL, & 400mg/20mL, for further dilution before IV infusion in the US
Company: Teva & Samsung Bioepis
Product: Epysqli
Active Ingredient: Eculizumab-aagh
Reference Product: Soliris
Reference Product Company: AstraZeneca
Disease: Paroxysmal Nocturnal Hemoglobinuria, Atypical Hemolytic Uremic Syndrome & Generalized Myasthenia Gravis
Date: Apr 07, 2025
Shots:
- Teva & Samsung Bioepis have launched Epysqli, a biosimilar version of Soliris (eculizumab) in the US to treat paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) & generalized myasthenia gravis (gMG) in AchR antibody-positive adults
- Epysqli was approved by the US FDA in Jul 2024 for PNH & aHUS, with a label expansion to gMG in Nov 2024 & was also granted interchangeability designation by the FDA
- In Jan 2025, Samsung Bioepis & Teva have entered into a collaboration to commercialize Epysqli in the US market, with Samsung handling development, manufacturing, & supply, whereas Teva would handle commercialization
Company: Biocon Biologics
Product: Jobevne
Active Ingredient: Bevacizumab-nwgd
Reference Product: Avastin
Reference Product Company: Roche
Disease: Multiple Indications of Avastin
Date: Apr 10, 2025
Shots:
- The US FDA has approved Jobevne, a biosimilar version of Avastin (bevacizumab) for IV administration
- Approval was based on extensive data showing Jobevne is similar to Avastin in PK, safety, efficacy, structure, & function across clinical & analytical studies
- Jobevne (VEGF inhibitor) is marketed under the brand name Abevmy in the EU & Canada, with approvals granted in Feb & Nov 2021, respectively
Company: Intas Pharmaceuticals & Coherus BioSciences
Product: Udenyca
Active Ingredient: Pegfilgrastim-cbqv
Reference Product: Neulasta
Reference Product Company: Amgen
Disease: Febrile Neutropenia
Date: Apr 14, 2025
Shots:
- Intas has acquired Coherus’ Udenyca business (incl. prefilled syringe, autoinjector & on-body injector), a biosimilar version of Amgen’s Neulasta (pegfilgrastim) via 2024 asset purchase agreement; Accord BioPharma (Intas’ US specialty division) will handle Udenyca’s US business
- As per the deal, Coherus received $483.4M upfront in cash, incl. $118.4M for Udenyca inventory, with an additional ~$75M contingent on Intas achieving 2 predefined sales-based milestones
- Coherus will get $250M post-close cash balance, extending its cash runway into 2027 to support pipeline development, incl. loqtorzi (PD-1 inhibitor), casdozokitug (IL-27 antagonist), & CHS-114 (selective CCR8 antibody)
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: Apr 14, 2025
Shots:
- The US FDA has granted interchangeability designation to Yuflyma, a biosimilar version of Humira (adalimumab)
- Designation was backed by P-III interchangeability trial showing comparable PK, efficacy, safety, & immunogenicity in pts with mod. to sev. PsO receiving reference adalimumab (ADA) continuously or those who alternated between ADA & Yuflyma during Wk. 25-27; data was presented at EADV 2024
- Yuflyma is a high-concentration (100mg/mL), citrate-free Humira formulation that is available in 20mg, 40mg, & 80mg doses for injection in a prefilled syringe or an autoinjector pen
Company: Biocon Biologics & Regeneron
Product: Yesafili
Active Ingredient: Aflibercept-jbvf
Reference Product: Eylea
Reference Product Company: Bayer
Disease: Neovascular Age-Related Macular Degeneration (nAMD) & Other Retinal Diseases
Date: Apr 15, 2025
Shots:
- Biocon Biologics & Regeneron have entered into a settlement & license agreement, allowing the US launch of Yesafili, an interchangeable biosimilar version of Eylea (aflibercept) by H2’26
- Yesafili’s FDA approval was supported by analytical, nonclinical & clinical data incl. P-III (INSIGHT) trial assessing Yesafili vs Eylea in DME pts, confirming its similarity in PK, safety, efficacy & immunogenicity
- Additionally, Biocon Biologics reached a settlement in Mar, 2024 with Bayer & Regeneron, allowing Canadian launch of Yesafili by Jul 1, 2025
- Gedeon Richter Receives CHMP’s Positive Opinion for Junod and Yaxwer (Biosimilars, Prolia and Xgeva)
Company: Gedeon Richter
Product: Junod and Yaxwer
Active Ingredient: Denosumab
Reference Product: Prolia and Xgeva
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events
Date: Apr 25, 2025
Shots:
- The CHMP has recommended marketing authorization for Junod and Yaxwer, biosimilars of Amgen’s Xgeva & Prolia (denosumab)
- Denosumab is approved to treat postmenopausal osteoporosis, prevent bone complications from cancer metastases, and treat unresectable giant cell tumors of bone
- Junod & Yaxwer are mAbs (IgG2) that blocks RANKL, preventing osteoclast activation
Company: CuraTeQ Biologics
Product: Dazublys
Active Ingredient: Trastuzumab
Reference Product: Herceptin
Reference Product Company: Roche
Disease: Breast Cancer
Date: Apr 26, 2025
Shots:
- CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, reported EMA’s CHMP has granted a positive opinion to Dazublys (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, to treat HER2-positive metastatic and early breast cancers. Pending expected EC approval in July, it will be available across the EU member states
- The opinion was based on its demonstrated similarity to Herceptin in PK, PD, efficacy, safety, and immunogenicity
- Trastuzumab targets and inhibits the HER2 protein, which is overexpressed in certain cancers like breast and gastric cancer
Company: Biocon Biologics
Product: Vevzuo & Denosumab BBL
Active Ingredient: Denosumab
Reference Product: Prolia and Xgeva
Reference Product Company: Amgen
Disease: Osteoporosis & Prevention of Skeletal-Related Events
Date: Apr 28, 2025
Shots:
- The CHMP has recommended Vevzuo & Denosumab BBL (brand name under approval), biosimilars of Xgeva & Prolia (denosumab)
- Opinion was based on the comprehensive clinical data submitted by Biosimilar Collaborations Ireland (Biocon Biologics’ subsidiary) incl. trials, which showed comparable PK, safety, efficacy & immunogenicity to the reference
- Denosumab is a mAb that works by targeting RANKL which regulates bone metabolism & osteoclast formation
Company: Henlius & Sandoz
Product: HLX13
Active Ingredient: Ipilimumab
Reference Product: Yervoy
Reference Product Company: BMS
Disease: Melanoma, Renal Cell Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Non-Small Cell Lung Cancer, Malignant Pleural Mesothelioma, and Esophageal Cancer
Date: Apr 29, 2025
Shots:
- Henlius has granted Sandoz exclusive rights of the HLX13, a biosimilar version of Yervoy (ipilimumab), which is being assessed in a Henlius-led P-I/III trial for inoperable HCC, targeting enrollment of 656 pts
- As per the deal, Sandoz will register & market HLX13 in Australia, Canada, EU, Japan, & the US in exchange for milestone-based payment of ~$301M, incl. $31M upfront post Yervoy patent expiry by Feb 2026 in the EU & Mar 2025 in the US, while Henlius will handle development & manufacturing
- Also, Sandoz is assessing its Opdivo biosimilar in P-I/III trial for advanced melanoma with a target enrollment of 720 pts & expects to launch its denosumab biosimilars, Wyost & Jubbonti, in the US by Q2’25 & EU by Q4’25
Note: The following biosimilar received the CHMP’s Positive Opinion. However, as of April 30, 2025, no PR was available:
- Zadenvi (Biosimilar, Denosumab)
- Izamby (Biosimilar, Denosumab)
- Enwylma (Biosimilar, Denosumab)
- Denbrayce (Biosimilar, Denosumab)
Related Post: Key Biosimilars Events of March 2024
