Celltrion said March 13 that as global regulators roll out policies to ease requirements for biosimilar development, it will immediately apply the changes across its biosimilar pipeline to cut costs and shorten timelines.
The U.S. Food and Drug Administration recently issued a fourth revision to its Q&A guidance on biosimilar development aimed at streamlining the process. The update recommends more efficient approaches to pharmacokinetic (PK) testing typically conducted in Phase 1, when scientific requirements are met.
The revision also relaxes reference-product requirements. Previously, companies seeking entry into the U.S. market had to run direct PK comparative studies against a U.S.-licensed reference product. Under the updated approach, equivalence may be supported using clinical data comparing a reference product approved outside the United States.
Celltrion said its immuno-oncology biosimilar programs face high reference-product costs and could reduce total clinical trial expenses by up to 25%.
Daewoong Pharmaceutical said March 13 it has concluded “Digital Health Week 2026,” which it described as the domestic pharmaceutical industry’s first intensive seminar week composed solely of digital health care products.
The event ran March 3-6 as a series of live online seminars on the medical-professionals platform Dr.Ville.
The program spotlighted eight Daewoong digital health care products, covering practical clinical-use cases, shifts in patient management, and strategies for more efficient hospital operations. The company said it held eight sessions in total, with two sessions each day at lunchtime and in the evening, featuring clinicians who prescribe and use the products.
Daewoong said it plans to continue offering academic programs designed to provide operational insights for medical professionals.
HLB Group said March 13 it will present new research findings on key cancer pipeline programs at the AACR 2026 Annual Meeting, to be held April 17-22 in San Diego.
AACR is one of the world’s three major cancer conferences, alongside the American Society of Clinical Oncology and the European Society for Medical Oncology, bringing together researchers and pharmaceutical and biotech companies to share the latest findings.
Verismo Therapeutics, a U.S. subsidiary of HLB Innovation, plans to present interim results from a U.S. Phase 1 trial of SynKIR-110, a chimeric antigen receptor T-cell (CAR-T) therapy for solid tumors. HLB said the trial design and progress have been introduced at several global conferences, but this will be the first time clinical data are disclosed.
Hugel said March 13 it participated in Thailand’s largest dermatology conference to promote its botulinum toxin and hyaluronic acid (HA) filler products and strengthen its presence in Southeast Asia.
The company attended the annual meeting of the Dermatological Society of Thailand, held March 11-13 at Centara Grand at CentralWorld in Bangkok, together with its local partner.
Marking its 50th edition this year, the DST meeting is Thailand’s largest dermatology conference, drawing local medical experts and aesthetics industry participants to share research updates and procedure trends.
During the meeting, Hugel promoted its botulinum toxin Botulax, exported in Thailand under the name Estox, along with its HA filler The Chaeum, exported as Revolax. The company also ran a separate academic program to share Revolax’s global clinical experience and procedural know-how.
* This article has been translated by AI.
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