Biosimilar Development

By Varun Venkatachalam and Jim Morris, IQS Consulting This is the second article in a three-part series on electronic quality management systems (eQMS) in pharma and biotech. The first article addressed selection of an eQMS.

Incheon, South Korea (BUSINESS WIRE) - Celltrion (KRX: 068270) today announced the launch of the 300 mg strength of Omlyclo® (omalizumab), a treatment for chronic spontaneous urticaria and allergic asthma, in Europe.1 With the addition of the 300 mg strength, Celltrion has expanded its Omlyclo® portfolio to include multiple dose strengths and device presentations for patients, healthcare professionals and healthcare institutions.

Former Deputy Director of the FDA’s Office of Neuroscience Dr. Lee has previously advised AEON through Clintrex Research LLC (Clintrex), an affiliate of BlueRidge Life Sciences, on the regulatory strategy for ABP-450 Aliso Viejo, CA (GLOBE NEWSWIRE) - AEON Biopharma, Inc.

Reykjavik, Iceland (GLOBE NEWSWIRE) - Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced a strategic licensing and commercialization agreement with Lotus Pharmaceutical (TWSE Stock Code: 1795) covering two of Alvotech’s candidates in the United States and selected Asian markets: AVT34, a proposed biosimilar to Imfinzi® (durvalumab), and AVT87, a proposed biosimilar to...

Adds Chicago research and development facility, New Jersey manufacturing site The Association for Accessible Medicines today commented on the announcement by Amneal Pharmaceuticals, Inc. of the completion of their acquisition of U.S. based Kashiv BioSciences, which creates a fully end-to-end biosimilars capacity, from research, development, manufacturing, and commercialization.

Helpful Biosafety Testing Innovations Where And When You Need Them Monoclonal antibody manufacturing is advancing to boost efficiency, cut costs, and expand access, driven by innovation, demand, and the rise of biosimilars. Takeda designed a model for delivering steam at 11 bar and up to 184 degrees using natural refrigerant and waste heat at one of its largest production sites.

Complementary peptide-mapping methods increased coverage of the active botulinum neurotoxin primary sequence from approximately 93% to 98%, with 100% amino acid identity across all regions analyzed Preliminary analysis demonstrates preservation of the critical disulfide bond architecture required for toxin activation Primary amino acid sequence and disulfide connectivity are foundational to establishing molecular similarity between ABP-450 and BOTOX® FDA feedback from planned Biosimilar...

Spare parts play a critical role in keeping equipment operational and avoiding costly, unexpected downtime. Custom components can take weeks or months to design, manufacture, ship, and install, making advance planning essential. A well-designed spare parts strategy helps reduce emergency service costs, protect productivity, and support stronger financial, scientific, and operational outcomes. However, selecting the right components requires more than identifying parts that appear identical.

Chromatography systems support critical decisions across pharmaceutical, biopharmaceutical, and life sciences operations, but today’s instruments face greater demands than ever. Higher operating pressures, complex separations, laboratory digitalization, and intensified regulatory scrutiny have made consistent equipment performance essential. Maintenance now directly affects uptime, data integrity, compliance, and the ability to advance new therapies.

Preventive maintenance may work behind the scenes, but its impact reaches across biopharmaceutical manufacturing. Regularly servicing equipment helps prevent unexpected failures, reduce costly delays, and keep manufacturing and testing processes on schedule. Its importance continues to grow as the industry moves toward continuous bioprocessing, where equipment must operate reliably for extended periods with minimal interruption.