​U.S. FDA grants interchangeable designation to YUFLYMA, Celltrion's biosimilar to Humira

YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar, that is now interchangeable Interchangeable designation of YUFLYMA® is supported by positive data from the Phase III interchangeability study in patients with moderate-to-severe plaque psoriasis [Press Release] INCHEON, South Korea, April 14, 2025 -- Celltrion(셀트리온), Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated YUFLYMA® (adalimumab

K-Beauty Trouble-Care Leader 'Fation' Debuts Nosca9 Deep Pore Cleanser in the U.S

[Press Release] SEOUL, South Korea, April 16, 2025 -- Korean skincare favorite Fation, the top-rated trouble-care brand at Olive Young with a near-perfect 4.9/5.0 rating, has officially launched in the U.S. market. Next rookie following after its best selling 'Trouble' Line, the Nosca9 Deep Pore Cleansing Foam, hit Amazon in March—and the response has been immediate. Named an Amazon "Overall Pick" and boasting an average rating above 4.7 stars, the product is already gaining momentum among beaut

GC Biopharma Receives MFDS Approval for World's First Recombinant Anthrax Vaccine

[Press Release] YONGIN, South Korea, April 9, 2025 -- GC Biopharma(GC녹십자) announced 09. Apr. 2025 that the Korean Ministry of Food and Drug Safety (MFDS) has approved its anthrax vaccine, BARYTHRAX, jointly developed by GC Biopharma and the Korea Disease Control and Prevention Agency (KDCA). With the approval by MFDS, BARYTHRAX has become Korea's 39th novel drug. Following the application on 31 Oct. 2023, GC Biopharma and KDCA successfully received the product approval from MFDS on 8th this mont

Ustekinumab Biosimilars May Ease Budget Pressures and Improve Access in Europe, IMKASID 2025 Analysis Shows

· Total expected savings from ustekinumab biosimilars estimated to be €526 million in Germany, the United Kingdom and Sweden over three years; annual saving per patient estimated to be €5,167, €709, and €3,388 in the respective countries · The Samsung Bioepis and Sandoz* biosimilar Pyzchiva® (ustekinumab) has been commercially available in Europe since July 2024 · Real-world safety and effectiveness of adalimumab biosimilar in Korea based on post-marketing surveillance was also presented at the

A​BL Bio Announces Grabody-B Brain Delivery Platform License Agreement with GSK

- ABL Bio and GSK enter into a multi-program agreement to develop novel medicines for neurodegenerative diseases - Programs will leverage ABL Bio's Grabody-B platform technology to effectively deliver molecules across the blood-brain barrier - ABL Bio to receive up to £77 million in upfront and near-term payments [Press Release] SEONGNAM, South Korea, April 7, 2025 ABL Bio Inc., a clinical-stage biotech company developing bispecific antibody technology for immuno-oncology and neurodegenerative d

PanGen contracts with Huonslab for biopharmaceutical process characterization study

[Press Release] On March 5, Huons Group PanGen (CEO Jaeseung Yoon) will conduct research services for Huonslab's biopharmaceutical product license. PanGen announced today that it has signed a research service contract with Huonslab for biopharmaceutical process characterization. The total value of the contract is KRW 800 million, and the process characterization research conducted through this contract is a service to design a standard process suitable for commercial-scale production of biopharm

Medytox signs botulinum toxin distribution agreement worth USD 73 million with Blau Farmacêutica, from Brazil

Blau Farmacêutica S.A. (Brazil B3 BLAU3) will distribute Medytox’s products in the Brazilian market on an exclusive basis [Press Release] Medytox (CEO Hyun Ho Jung) announced on March 26th, 2024 that the biopharmaceutical company had entered into a distribution agreement (the "Agreement") with BLAU FARMACEUTICA S.A. (CEO Marcelo Hahn) for botulinum toxin at USD 73 million (based on minimum order quantity) for five years. Medytox will supply its botulinum toxin products (including Newlux) to Blau, which will distribute Medytox’s products in the territory of Brazil. The long-term Agreement came in the aftermath of Bl

Celltrion's STEQEYMA (ustekinumab-stba), now added to the Costco Member Prescription Program

Celltrion's adalimumab-aaty was previously added to the Costco Member Prescription Program in August 2024 [Press Release] On March 27, Celltrion announced that STEQEYMA (ustekinumab-stba), a biosimilar to STELARA (ustekinumab) has been added to the Costco Member Prescription Program. "We're focused on improving affordability and access to a widely used, high-cost treatment for a variety of inflammatory conditions," said Francine Galante, Vice President of Market Access at Celltrion USA. "The addition of STEQEYMA to the Costco Member Prescription Program together with adalimumab-aaty will help us del

Handok’s Collaborator, Compass Therapeutics, Announces Positive Topline Results from Phase 2/3 of Tovecimig (HDB001A)

Handok plans to use COMPANION-002 clinical results for domestic approval of tovecimig (HDB001A) [Press Release] Handok's collaborator, Compass Therapeutics, announced positive topline results of COMPANION-002, a Phase 2/3 trial of tovecimig (HDB001A) in patients with metastatic or recurrent biliary tract cancer on April 1st (U.S. time). Handok and Compass Therapeutics have been collaborating on the development of tovecimig (HDB001A), an innovative bispecific antibody drug with high potential as a biliary tract cancer treatment. Compass Therapeutics has conducted the Phase 2/3 trial, COMPAN

ST PHARM Participates in DCAT Week 2025, Seeking Global Partnerships

Continuing participation following last year, aiming to attract global clients [Press Release] ST PHARM announced on March 21st that it participated in the Drug, Chemical & Associated Technologies (DCAT) Week 2025, held in New York City from March 17th to 20th. DCAT Week, which began in 1890 under the auspices of the New York Chamber of Commerce, is a premier event in the pharmaceutical and biotech sectors with over 150 years of tradition. The event is well-known for providing various forms of B2B partnering meetings, especially as it attracts high-level executives with de