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Celltrion to Break Ground on Massive New Biopharmaceutical Plant
Plans for a $453.3 million high volume plant and research center were unveiled during an industry forum this week in Republic of Korea.
Celltrion Healthcare has unveiled plans to build a $453.3 million biopharmaceutical plant and research center near its base of operations in Incheon, Republic of Korea. The company said the buildout is supported by rapidly increasing biopharmaceutical demand across the globe.
The biosimilar developer aims to build a 60,000-liter biopharmaceutical plant for diverse types of production needs and also a research center employing 2000 professional biodevelopment personnel for high-level activities related to expanding the company’s pipeline of medicines, including biosimilars, according to a report in the Korea Biomedical Review. The plans were announced during a biopharmaceutical industry forum this week in Korea.
Celltrion aims to complete the research center and the factory by July 2022 and May 2023, respectively, with the factory starting operations by June 2024. The additional plant will give Celltrion a total production capacity of 250,000 liters annually, up from 190,000 at its 2 existing plants.
Eight 7500-liter incubators will shorten the time between manufacture of drug batches, the company said. A fourth plant also is in the planning stages, although further details were not provided, according to the press report.
In August, Samsung Biologics announced plans for $2 billion in spending on what it called the world's largest factory and biopharmaceutical production center, also in Incheon. The company aims to begin production at the site by the second half of 2022.
BioRationality: Withdrawal of Proposed Terminal Disclaimer Rule Spells Major Setback for Biosimilars
December 10th 2024The United States Patent and Trademark Office (USPTO)’s withdrawal of its proposed terminal disclaimer rule is seen as a setback for biosimilar developers, as it preserves patent prosecution practices that favor originator companies and increases costs for biosimilar competition, according to Sarfaraz K. Niazi, PhD.
Biosimilars Development Roundup for October 2024—Podcast Edition
November 3rd 2024On this episode of Not So Different, we discuss the GRx+Biosims conference, which included discussions on data transparency, artificial intelligence (AI), and collaboration to enhance the global supply chain for biosimilars and generic drugs, as well as the evolving requirements for biosimilar devices.
Pertuzumab Biosimilar Shows Promise in HER2-Positive Breast Cancer Treatment
December 9th 2024The proposed pertuzumab biosimilar QL1209 demonstrated equivalent efficacy and safety to reference pertuzumab (Perjeta) in neoadjuvant treatment of HER2-positive, ER/PR-negative early or locally advanced breast cancer, offering a cost-effective alternative with comparable clinical outcomes.
Biosimilars in America: Overcoming Barriers and Maximizing Impact
July 21st 2024Join us as we explore the complexities of the US biosimilars market, discussing legislative influences, payer and provider adoption factors, and strategies to overcome industry challenges with expert insights from Kyle Noonan, PharmD, MS, value & access strategy manager at Cencora.
Aflibercept Biosimilar MYL-1701P Provides Equivalence in DME Therapy
November 27th 2024The study findings demonstrate that the aflibercept biosimilar MYL-1701P is as effective and safe as the reference aflibercept in treating diabetic macular edema (DME), offering a promising option for reducing treatment costs and improving global access to care for patients with DME.
Ocrelizumab Biosimilar Shows Equivalent Efficacy as Multiple Sclerosis Treatment
November 26th 2024The phase 3 trial (NCT04966338) found that a biosimilar ocrelizumab candidate (Xacrel) was equivalent to Ocrevus in reducing the annualized relapse rate and showed comparable safety and efficacy in treating relapsing multiple sclerosis over 96 weeks.
