Shots:
- Regulatory momentum remained strong, with key biosimilar launches and approvals including Celltrion’s Remsima IV (EU) and Avtozma SC (US), Teva’s FDA-approved Ponlimsi, Japan’s approval of tocilizumab BS MA by Mochida Pharmaceutical and AYUMI Pharmaceutical, and IND clearance for HLX18 by National Medical Products Administration.
- Strategic partnerships expanded access, led by Samsung Bioepis–Sandoz collaboration, Formycon’s aflibercept settlement deal with Regeneron Pharmaceuticals and Bayer, and Bio-Thera Solutions–Intas Pharmaceuticals partnership in India.
- Pipelines and manufacturing advanced, with P-III success for HD204 by Prestige Biopharma, multiple assets progressing at Henlius, and manufacturing expansion via Cytiva’s Japan facility, supporting readiness for 2026–2028 launches.
Company: Celltrion
Product: Remsima IV
Active Ingredient: Infliximab
Reference Product: Remicade
Reference Product Company: Johnson & Johnson
Disease: Crohn’s Disease, Rheumatoid Arthritis, Ulcerative Colitis, Ankylosing Spondylitis, Psoriatic Arthritis, and Plaque Psoriasis
Date: Mar 11, 2026
Shots:
- Following the EU approval of Remsima IV in Nov’25, Celltrion launched Remsima IV, a biosimilar version of Remicade (Infliximab), across Europe
- Celltrion has filed and secured patents for the Remsima liquid formulation across most EU countries, including key markets such as the UK, Germany, and France
- The Remsima liquid formulation adds to existing IV (100 mg lyophilized) and SC options, aligning with clinical demand in Europe for a multi-dose format that may simplify storage and preparation. Celltrion has introduced a 350 mg liquid version and is continuing its sales and marketing efforts. Celltrion also secured Nordic tender contracts in Denmark and Norway, with supply in Norway planned through Jan’28
Company: Celltrion
Product: Avtozma SC
Active Ingredient: Tocilizumab
Reference Product: Actemra
Reference Product Company: Roche
Disease: Rheumatoid Arthritis, Giant Cell Arteritis, Polyarticular Juvenile Idiopathic Arthritis, and Systemic Juvenile Idiopathic Arthritis
Date: Mar 17, 2026
Shots:
- Celltrion launched Avtozma SC, a biosimilar to Actemra (tocilizumab), in the US, becoming among the first to offer both IV & SC formulations approved by the US FDA & available in the market
- Avtozma received the FDA & EC approval in Jan & Feb 2025, respectively, based on a global P-III trial showing comparable efficacy, PK, safety & immunogenicity vs reference tocilizumab, followed by an additional Jul 2025 FDA approval for its IV formulation to treat pts (≥2yrs.) with cytokine release syndrome
- Avtozma SC is a recombinant humanized mAb that targets the IL-6 receptor & is available in 162mg/0.9mL in single-dose prefilled syringe or a single-dose prefilled autoinjector
Company: Samsung Bioepis & Sandoz
Product: SB36 and etc
Active Ingredient: Vedolizumab and etc
Reference Product: Entyvio and etc
Reference Product Company: Takeda and etc
Disease: All Approved Indications
Date: Mar 18, 2026
Shots:
- Samsung Bioepis has entered into a global license, development & commercialization agreement with Sandoz for up to five biosimilars, incl. SB36 (preclinical), a biosimilar version of Entyvio (vedolizumab)
- Samsung Bioepis will handle development, manufacturing & regulatory filings, while Sandoz will lead commercialization globally (excl. China, Hong Kong, Taiwan, Macau & Republic of Korea)
- The deal builds on the prior partnership (Sep 2023) for Pyzchiva (Biosimilar, Stelara), launched in EU (Jul 2024) & US (Feb 2025), & follows their Dec 2025 deal for Epysqli (Biosimilar, Soliris) in Middle East & Africa region
Company: Formycon, Regeneron, and Bayer
Product: FYB203
Active Ingredient: Aflibercept
Reference Product: Eylea
Reference Product Company: Bayer
Disease: Neovascular (wet) age-related macular degeneration, Diabetic macular edema, Choroidal neovascularization, Proliferative diabetic retinopathy (PDR), and Macular edema following retinal vein occlusion
Date: Mar 19, 2026
Shots:
- Formycon has signed a settlement and license agreement with Regeneron and Bayer for the commercialization of FYB203, a biosimilar version of Eylea 2 mg (aflibercept 0.05 ml of 40 mg/mL solution), in the EU
- Under the agreement, both products may launch in the EU and other regions, including LATAM and Asia-Pacific, from May 2026. Earlier, in October 2025, Formycon secured a US license date for FYB203 in Q4’26 under its agreement with Regeneron
- Ahzantive & Baiama (aflibercept) inhibits VEGF, preventing abnormal blood vessel growth in the retina that can lead to vision loss, and was approved in the EC for treating nAMD and other serious retinal diseases
Company: Henlius
Product: HLX18
Active Ingredient: Nivolumab
Reference Product: Opdivo
Reference Product Company: BMS
Disease: Renal Cell Carcinoma, Melanoma, Non-Small Cell Lung Cancer, Squamous Cell Carcinoma of the Head and Neck, Urothelial Carcinoma, Colorectal Cancer, Hepatocellular Carcinoma, Esophageal Cancer, and Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma
Date: Mar 20, 2026
Shots:
- The Chinese NMPA has granted IND approval to HLX18, a biosimilar version of Opdivo (nivolumab) for the treatment of certain resected solid tumors following the US FDA IND clearance
- Additionally, HLX17 (biosimilar, Keytruda) & HLX13 (biosimilar, Yervoy) are under P-I trials with first patient dosing completed, while the IND for HLX15-SC (biosimilar, Darzalex), was also cleared by both the NMPA & FDA
- Also, HLX43, a PD-L1-targeting ADC, has shown favorable early efficacy & manageable safety in solid tumors, incl. NSCLC, & has advanced into a global P-II/III trial in the US for advanced or metastatic squamous NSCLC
Company: Prestige Biopharma
Product: HD204
Active Ingredient: Bevacizumab
Reference Product: Avastin
Reference Product Company: Genentech
Disease: Colorectal Cancer, Non-squamous Non-small Cell Lung Cancer, Recurrent Glioblastoma, Renal Cell Carcinoma, Cervical Cancer, Epithelial Ovarian, Fallopian Tube, Or Primary Peritoneal Cancer, and Hepatocellular Carcinoma
Date: Mar 23, 2026
Shots:
- Prestige has reported the topline P-III (SAMSON-II) trial results evaluating HD204, a biosimilar version of Avastin (bevacizumab), vs Avastin in 625 adults with advanced non-squamous NSCLC
- Trial showed an ORR of 48.7% vs 46.5% at 18wks., meeting its 1EP & showing clinical equivalence between HD204 & Avastin; 2EPs supported the primary analysis, with similar Wk. 12 ORR responses & no significant differences in PFS or OS between groups
- SAMSON-II outcomes were consistent with strong analytical & PK similarity between HD204 & Avastin, supporting Prestige’s advancement of regulatory pathways based on robust analytical & clinical PK data
Company: Intas Pharmaceuticals & Bio-Thera
Product: BAT2506
Active Ingredient: Golimumab
Reference Product: Simponi
Reference Product Company: Johnson & Johnson
Disease: Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, and Ulcerative Colitis
Date: Mar 23, 2026
Shots:
- Bio-Thera Solutions expanded its partnership with Intas Pharmaceuticals for BAT2506, a proposed biosimilar of Simponi (golimumab), through an exclusive commercialization and licensing agreement for India
- BAT2506 is a proposed golimumab biosimilar by Bio-Thera. Golimumab, a human IgG1 monoclonal antibody, targets TNF-α to reduce key inflammatory markers such as CRP, IL-6, ICAM-1, MMP-3, and VEGF. The reference drug is approved in Canada for conditions including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis
- The expanded collaboration combines Bio-Thera’s development capabilities with Intas’ commercial strength in India, aiming to improve access to high-quality biosimilars in immunology. The deal also strengthens Intas’ biologics portfolio and reflects both companies’ focus on advancing affordable, science-driven therapies in high-demand markets like India
Company: Cytiva and Yoshindo
Product: N/A
Active Ingredient: N/A
Reference Product: N/A
Reference Product Company: N/A
Disease: N/A
Date: Mar 23, 2026
Shots:
- Cytiva and Yoshindo sign a FlexFactory contract to support the establishment of domestic biosimilar drug substance manufacturing in Japan. The investment is partly supported by Japan’s MHLW
- Yoshindo plans to supply biosimilars from its Toyama plant starting in 2028, supporting a stable and affordable biologics supply in Japan
- Cytiva’s FlexFactory platform uses modular bioprocessing technologies to support faster transition from facility design to GMP production. Following a design phase completed in early 2026, Yoshindo was able to outline its manufacturing operations and estimate key requirements
Company: Mochida Pharmaceutical and AYUMI Pharmaceutical
Product: Tocilizumab BS MA
Active Ingredient: Tocilizumab
Reference Product: Actemra
Reference Product Company: Genentech
Disease: Rheumatoid Arthritis, Polyarticular-course juvenile idiopathic arthritis, Systemic juvenile idiopathic arthritis, Cytokine release syndrome, SARS‑CoV‑2 pneumonia
Date: Mar 23, 2026
Shots:
- The company has received manufacturing and marketing approval in Japan for tocilizumab BS MA, a biosimilar version of Actemra (tocilizumab)
- Tocilizumab BS MA, a biosimilar jointly developed by Mochida Pharmaceutical and Gedeon Richter. Under their agreement with AYUMI Pharmaceutical, Mochida will supply the product, while AYUMI will handle its sales in Japan
- Mochida Pharmaceutical and AYUMI Pharmaceutical previously collaborated to commercialize Etanercept BS MA (2018) and Adalimumab BS MA (2021)
Company: Teva Pharmaceutical
Product: Ponlimsi & Omalizumab
Active Ingredient: Denosumab & Omalizumab
Reference Product: Prolia & Xolair
Reference Product Company: Genentech and Novartis & Amgen
Disease: Osteoporosis & Prevention of Skeletal Related Events, Moderate to severe persistent asthma, Chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy, and Chronic spontaneous urticaria
Date: Mar 30, 2026
Shots:
- The US FDA has approved Ponlimsi, a biosimilar version of Prolia (denosumab), for all indications of the reference product
- Approval was based on extensive clinical data, incl. analytical & clinical studies, which showed comparable efficacy, safety, & immunogenicity of Ponlimsi to reference product
- Additionally, Teva’s biosimilar of Xolair (omalizumab) was accepted for review by the US FDA & EMA across all approved indications, backed by a comprehensive package of analytical & clinical data showing similar efficacy, safety, & immunogenicity to the reference product
Related Post: Key Biosimilars Events of February 2026
