Celltrion Inc
🇰🇷South Korea
- Country
- 🇰🇷South Korea
- Ownership
- -
- Established
- 1999-01-01
- Employees
- -
- Market Cap
- $31.9B
- Website
- http://www.celltrion.com/
Hyundai ADM Bio Pivots Strategy to Focus on Immunotherapy Combinations for Cancer Treatment
• Hyundai ADM Bio has voluntarily withdrawn its IND application for Penetrium™ with docetaxel to strategically refocus on immunotherapy combinations, with plans to submit a new IND application this month.
• The company's ECM-targeting agent Penetrium™ demonstrated promising results in preclinical studies, reducing tumor volume by 48.3% when combined with anti-PD-1 therapy in triple-negative breast cancer models.
• This strategic shift positions Hyundai ADM Bio to capitalize on the expanding immuno-oncology market, projected to grow from $43.7 billion in 2023 to $284.7 billion by 2033, particularly as major patents expire starting in 2028.
Celltrion to Present New ZYMFENTRA® Data for IBD Management at 2025 Digestive Disease Week
• Celltrion will present six abstracts at the 2025 Digestive Disease Week, featuring post-hoc analyses and real-world evidence for ZYMFENTRA®, the first FDA-approved subcutaneous infliximab.
• The presentations will highlight ZYMFENTRA's performance across diverse patient populations with moderate-to-severe Crohn's disease and ulcerative colitis, addressing individualized treatment approaches.
• These data reinforce Celltrion's commitment to providing comprehensive clinical evidence to healthcare professionals for informed treatment decisions in the evolving IBD landscape.
Abpro and Celltrion's ABP-102/CT-P72 Shows Promise as Best-in-Class HER2 T-Cell Engager
• Preclinical data presented at AACR 2025 demonstrates ABP-102/CT-P72's superior tumor selectivity and reduced toxicity compared to existing HER2-targeted T-cell engagers.
• The novel bispecific antibody showed up to two-fold greater tumor suppression versus runimotamab biosimilar while maintaining safety at doses 180 times higher than the parental antibody's maximum tolerated dose.
• Developed through Abpro and Celltrion's strategic partnership, ABP-102/CT-P72 targets HER2-positive cancers that represent up to 30% of breast, gastric, pancreatic, and colorectal malignancies.
Sandoz Files Antitrust Lawsuit Against Amgen to Unlock Access to Etanercept Biosimilar in US Market
• Sandoz has initiated antitrust litigation against Amgen, alleging the company unlawfully blocked competition for its blockbuster drug Enbrel® (etanercept) by manipulating patent rights to maintain market dominance.
• Despite receiving FDA approval in 2016, Sandoz's biosimilar Erelzi® remains unavailable to approximately 7.5 million Americans with inflammatory conditions who could benefit from more affordable treatment options.
• The lawsuit seeks an injunction to clear the path for Erelzi® launch and damages that could be tripled under applicable laws, challenging Amgen's $3.3 billion US revenue stream from Enbrel® in 2024.
FDA Approves Biocon Biologics' Bevacizumab Biosimilar JOBEVNE for Multiple Cancer Indications
• Biocon Biologics has received U.S. FDA approval for JOBEVNE (bevacizumab-nwgd), a biosimilar to Avastin, expanding its oncology portfolio to include a seventh FDA-approved biosimilar.
• JOBEVNE, a VEGF inhibitor that restricts tumor blood supply, is indicated for multiple cancer types including metastatic colorectal cancer, non-small cell lung cancer, glioblastoma, and several others.
• The approval follows comprehensive comparative studies confirming JOBEVNE's similarity to Avastin, with U.S. bevacizumab sales reaching approximately $2 billion in 2023, representing a significant market opportunity.
Robust Pipeline of 80+ Therapies Advancing in Psoriasis Treatment Landscape
• DelveInsight's 2025 Psoriasis Pipeline Report reveals over 80 companies developing 80+ pipeline therapies, highlighting significant R&D investment in this therapeutic area.
• Promising treatments in development include topical roflumilast (Arcutis Biotherapeutics) in Phase III trials and GSK2982772 (GlaxoSmithKline), a novel RIPK1 inhibitor in Phase I development.
• Alumis Inc. has initiated a long-term extension study for ESK-001 in moderate to severe plaque psoriasis patients, evaluating safety, efficacy, and durability of response over 24 weeks.
2025 Pharmaceutical Pipeline: Major Patent Expirations Set to Transform Drug Market with Generics and Biosimilars
• The US pharmaceutical market is poised for significant change in 2025 as several blockbuster drugs including Xarelto, Entresto, and Stelara face patent expirations, opening the door to generic and biosimilar competition.
• Multiple biosimilars for ustekinumab (Stelara) are entering the market in 2025, with Wezlana already launched in January as the first interchangeable biosimilar, while other major drugs like ticagrelor and denosumab will also face competition.
• The pharmaceutical pipeline continues to expand with innovative therapies for cancer and neurological disorders, alongside the Medicare Drug Price Negotiation program which will further impact pricing dynamics for high-cost medications.
Novel Therapies Show Promise for Chronic Spontaneous Urticaria with Complete Response Rates Exceeding 30%
• Recent clinical trials demonstrate that emerging therapies including dupilumab, remibrutinib, and barzolvolimab achieve complete response rates of 28-51% in patients with chronic spontaneous urticaria (CSU) who are resistant to standard treatments.
• Remibrutinib, a novel oral Bruton tyrosine kinase inhibitor, showed rapid improvement in urticaria control as early as week 2 in phase 3 REMIX trials, with approximately 64% of patients achieving well-controlled disease by week 24.
• Long-term safety data for omalizumab reveals virtually no risk of anaphylaxis or serum sickness after 2.5 million injections over two decades, establishing its continued importance in the treatment landscape for severe allergic conditions.
Xolair Shows Superior Efficacy Over Oral Immunotherapy in Landmark Food Allergy Trial
• Phase III OUtMATCH study demonstrates Xolair's superior efficacy with 36% of patients tolerating multiple food allergens compared to 19% in the oral immunotherapy group.
• Xolair treatment showed significantly better safety profile with zero serious adverse events, while oral immunotherapy group experienced 30.5% serious adverse events and higher treatment discontinuation rates.
• Follow-up data reveals promising results for post-Xolair food introduction, with 61-70% success rates for milk, egg, and wheat allergens, though lower rates for nuts.
Four New Humira Biosimilars Launch in US Market with Steep Discounts up to 85%
• Multiple pharmaceutical companies including Organon, Samsung Bioepis, Sandoz, and Boehringer Ingelheim launched Humira biosimilars in July 2023, offering significant price reductions compared to the original drug.
• Boehringer Ingelheim's Cyltezo becomes the first FDA-approved interchangeable biosimilar to Humira, allowing direct substitution without requiring prescription changes.
• The biosimilar launches come as AbbVie's Humira faces declining sales, with international revenues dropping 25% in Q1 2023 following the drug's $200 billion lifetime sales.
Rheumatoid Arthritis Market Set to Reach $34.7 Billion by 2035, Driven by Novel Therapies and Rising Obesity Rates
• The global rheumatoid arthritis market is projected to grow from $28 billion in 2024 to $34.7 billion by 2035, with a CAGR of 1.97%, fueled by advancements in biologics and targeted therapies.
• Rising obesity rates, sedentary lifestyles, and urbanization are significantly contributing to increased rheumatoid arthritis prevalence, while also reducing the efficacy of some treatments.
• Novel treatment approaches including JAK inhibitors, monoclonal antibodies, and emerging therapies like R-2487 and IMVT-1402 are transforming the treatment landscape with more targeted mechanisms of action.
Celltrion's Phase 3 Study Validates Yuflyma's Interchangeability with Humira for Psoriasis Treatment
• A Phase 3 trial involving 367 Estonian patients demonstrated pharmacokinetic equivalence between Yuflyma and Humira in treating moderate to severe plaque psoriasis, with comparable efficacy and safety profiles.
• Celltrion has submitted a supplemental application to the FDA in January 2024 seeking interchangeability status for Yuflyma, which could streamline the prescription switching process.
• As the world's first high-concentration Humira biosimilar, Yuflyma offers advantages including reduced injection volume and citrate-free formulation, targeting a market where Humira generated $14.4 billion in global sales in 2024.
Sandoz's Denosumab Biosimilar Shows Promise in Osteoporosis Trial, Challenging Amgen's $5B Franchise
• Sandoz's biosimilar version of denosumab demonstrated equivalent efficacy, safety, and immunogenicity to Amgen's Prolia in postmenopausal women with osteoporosis through the ROSALIA phase 1/3 study.
• The development threatens Amgen's substantial revenue stream from Prolia and Xgeva, which generated combined sales of $5.25 billion last year, with patents expiring in key markets by 2025.
• The European Medicines Agency has newly declared all EU-approved biosimilars as interchangeable with their reference medicines, potentially accelerating biosimilar adoption across member states.
FDA Approves Celltrion's Avtozma, a Tocilizumab Biosimilar, for Multiple Inflammatory Conditions
• The FDA has approved Avtozma (tocilizumab-anoh), a biosimilar to Actemra, for treating rheumatoid arthritis, giant cell arteritis, and juvenile idiopathic arthritis.
• Avtozma is available in both intravenous and subcutaneous formulations, offering flexibility in treatment options for healthcare providers and patients.
• The approval was based on Phase 3 trial data demonstrating biosimilarity in efficacy, safety, pharmacokinetics, and immunogenicity compared to reference tocilizumab.
• Celltrion's Avtozma marks the company's seventh biosimilar approval in the U.S., expanding its immunology portfolio.
FDA Approves Steqeyma and Yesintek: Expanding Biosimilar Options for Stelara
• The FDA has approved Steqeyma (ustekinumab-stba) and Yesintek (ustekinumab-kfce) as biosimilars to Stelara, offering new options for patients with autoimmune and inflammatory conditions.
• Steqeyma and Yesintek are approved for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis, mirroring Stelara's indications.
• These approvals are expected to increase market competition and reduce treatment costs, with launches anticipated in early 2025 following licensing agreements.
Cell Therapy and Targeted Therapies Dominate Oncology Advances in Early 2025
• The FDA issued a CRL for Atara Biotherapeutics' tabelecleucel due to third-party manufacturing issues, not efficacy or safety data, delaying potential approval for EBV+ PTLD.
• EsoBiotec dosed the first patient in a trial for ESO-T01, an in vivo BCMA-directed CAR-T therapy for multiple myeloma, aiming for lower costs and simplified administration.
• Obecabtagene autoleucel (obe-cel) gained FDA approval for relapsed/refractory B-cell precursor ALL, offering a less toxic CD19-directed CAR T-cell therapy option.
• Arlocabtagene autoleucel (arlo-cel) shows promise in heavily pretreated relapsed/refractory multiple myeloma, eliciting a 48% complete response rate in phase 1 studies.
First RoActemra Biosimilar Tyenne Receives EU Approval, Marking Milestone for Fresenius Kabi
• The European Commission has granted approval for Tyenne, the first biosimilar version of Roche's blockbuster drug RoActemra (tocilizumab), developed by Fresenius Kabi for multiple inflammatory conditions and severe COVID-19.
• Tyenne is approved for all RoActemra indications, including rheumatoid arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome, representing a significant advancement in accessible treatment options.
• This approval marks Fresenius Kabi's third biosimilar success and aligns with their Vision 2026 strategy to generate €1 billion in additional revenue every three years.
US Biosimilar Market Set for $100 Billion Cost Reduction as Adoption Accelerates
• The US biosimilar market has shown significant growth with 20 approved products, projected to reduce drug costs by $100 billion over the next five years through increased competition and adoption.
• Recent oncology biosimilars in bevacizumab, trastuzumab, and rituximab markets are achieving record market share, expected to reach 60% combined volume share within two years of launch.
• Regulatory changes have expanded biosimilar categories to include 90 new molecules, with insulin biosimilars poised to enter the market and potentially transform diabetes care costs.
FDA Approves Ontruzant, Samsung Bioepis and Merck's Biosimilar to Herceptin for Cancer Treatment
• The FDA has granted approval for Ontruzant, a biosimilar version of Roche's Herceptin, developed by Samsung Bioepis and to be marketed by Merck & Co in the United States.
• The biosimilar is approved for multiple indications including HER2-positive breast cancer and metastatic gastric cancer, offering a potentially more affordable treatment option.
• This marks Samsung Bioepis' first FDA-approved oncology biosimilar, joining other competitors like Celltrion/Teva and Mylan in the Herceptin biosimilar market.
FDA Approves Sandoz's Erelzi as First Enbrel Biosimilar in US
• Sandoz's Erelzi (etanercept-szzs) has received FDA approval as the first biosimilar to Amgen's Enbrel, covering all indications of the reference product for inflammatory diseases.
• The approval marks a significant milestone in the US biosimilars landscape, potentially impacting the $5 billion annual US market for Enbrel.
• The biosimilar approval aligns with healthcare cost reduction goals, with IMS Health projecting potential savings of up to $110 billion by 2020 across the US and five largest EU countries.
© Copyright 2025. All Rights Reserved by MedPath