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Recent BioBlast® Updates

AbbVie announces $250M acquisition of biotech company Celsius Therapeutics

Jun 28, 2024

On 28 June 2024, AbbVie announced its acquisition of Celsius Therapeutics, a privately owned biotech firm developing treatments for patients suffering from inflammatory diseases. This includes CEL383, an anti-TREM1 antibody which has successfully completed a Phase 1...

Samsung Bioepis’ Biosimilar Ustekinumab Korean Launch at 40% Discount

Jun 27, 2024

On 27 June 2024, Korea Biomedical Review reported that Samsung Bioepis intends to launch its ustekinumab biosimilar Epyztek™ in Korea in July 2024. The product will be supplied at a 40% discount to J&J’s Stelara® (ustekinumab). Celltrion’s Steqeyma (CT-P43),...

Coherus Abandons Adalimumab Biosimilar, Sells Rights to Hong Kong King-Friend for $40M

Jun 27, 2024

On 27 June 2024, Coherus BioSciences announced that it has agreed to divest its Yusimry™, biosimilar to AbbVie’s Humira (adalimumab), to Hong Kong King-Friend (HKF) for up-front all-cash consideration of USD $40M. On the same day, Meitheal Pharmaceuticals, wholly...

Positive CHMP Opinion for Celltrion’s Ustekinumab Biosimilar

Jun 27, 2024

At its June 2024 meeting, EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Celltrion’s Steqeyma (CT-P43), biosimilar to Janssen’s Stelara® (ustekinumab). The recommendation is for moderately to severely active Crohn’s disease,...

Harbour BioMed Resubmits Batoclimab BLA to China’s NMPA with Additional Safety Data

Jun 27, 2024

On 27 June 2024, Harbour Biomed announced that it has resubmitted its Biologics License Application (BLA) for batoclimab (HBM9161) to the China’s National Medical Products Administration (NMPA) for the treatment of generalized myasthenia gravis. The resubmission...

Approval Alert: Novo Nordisk’s Wegovy® Approved in China

Jun 26, 2024

Novo Nordisk announced that Wegovy® has been approved in China for long-term weight management, targeting patients with a BMI of 30kg/m² and at least one weight-related comorbidity. The approval comes as the company plans a $4.1 billion expansion of its US...

Simcere Zaiming Cetuximab Beta Approved In China

Jun 26, 2024

On 25 June 2024, Simcere Zaiming announced the approval of Enlituo® (cetuximab beta) in the PRC for use in combination with the FOLFIRI regimen as a first-line treatment for RAS/BRAF wild-type metastatic colorectal cancer (mCRC). The drug was developed in...

Approval Alert: FDA Approves AbbVie’s Epkinly® for Follicular Lymphoma

Jun 26, 2024

On 26 June 2024, AbbVie announced that its Epkinly® (epcoritamab) received FDA approval for the treatment of adults with relapsed or refractory follicular lymphoma. This approval makes Epkinly® the first and only subcutaneous bispecific antibody approved in the US to...

Novo Nordisk Announces US$4.1B Investment to Expand US Manufacturing Capacity

Jun 25, 2024

On 25 June 2024, Novo Nordisk announced its plan to significantly boost its investment in manufacturing in 2024, allocating USD $6.8 billion towards production. This is up from USD $3.9 billion the previous year. The plan includes a USD $4.1 billion investment to...

Samsung Biologics signs $156m Contract Manufacturing deal with US based Kiniksa

Jun 25, 2024

Business Korea reports that Samsung Biologics has entered a contract manufacturing agreement with US based Kiniksa Pharmaceuticals. The deal, valued at approximately USD $156m (211b won) covers the period 21 June 2024 to 31 December 2031. This follows the...

Approval Alert: Celltrion’s Omlyclo is First Korean Approved Omalizumab Biosimilar

Jun 25, 2024

On 25 June 2024, Celltrion announced that its Omlyclo (CT-P39), biosimilar to Genentech’s and Novartis’ Xolair® (omalizumab), was approved by the Korean Ministry of Food and Drug Safety for allergic asthma and chronic idiopathic urticaria. This is the first...

Evotec Biologics Chosen by U.S. Department of Defense for Manufacturing Optimisation Program

Jun 25, 2024

On 25 June 2024, Evotec announced that its subsidiary, Just – Evotec Biologics, Inc., has been selected by the U.S. Department of Defense to develop an accelerated monoclonal antibody development and manufacturing solution as part of the department’s Manufacturing...