This is the sixth ustekinumab biosimilar approval in the United States, with the drug set to launch in 2025.

Medscape

United States

FDA Approves Ustekinumab Biosimilar Yesintek

Biocon Biologics Ltd (BBL) has received US Food and Drug Administration (FDA) approval for Yesintek, a biosimilar for Johnson & Johnson's reference product, Stelara.This approval marks a major breakthrough for Biocon Biologics, a fully integrated global biosimilars company and subsidiary of Biocon Ltd.Biosimilars are medicines similar to original medicines but available at a far lower price to make them accessible to large section of society who…

NDTV Profit

Biocon Biologics Receives US FDA Nod For Yesintek, A Biosimilar to J&J's Stelara

Shares of Biocon surged by 2.7% to Rs 375 on Monday following the U.S. FDA’s approval for Yesintek, a biosimilar to Johnson & Johnson’s blockbuster arthritis drug, Stelara. This approval marks a significant milestone for Biocon Biologics, strengthening its position as a global leader in biosimilars. About Yesintek Yesintek, a monoclonal antibody, is designed to treat multiple autoimmune conditions, including: 
Crohn’s disease Ulcerative colitis …

Business Upturn

Biocon shares surge nearly 3% after FDA nod for Yesintek, a biosimilar to Stelara

BENGALURU, Karnataka, India I December 01, 2024 I Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), announced today that the U.S. Food and Drug Administration (FDA) has approved YESINTEK™ (Ustekinumab-kfce), a biosimilar to the reference product, Stelara® (Ustekinumab). YESINTEK™, a monoclonal antibody, is approved for the treatment of Crohn’s disease, Ulcerati…

pipelinereview

U.S. FDA Approves Biocon Biologics’ YESINTEK™, Bmab 1200 biosimilar to J&J’s Stelara® (Ustekinumab) - Pipelinereview

Biocon Biologics, a global biosimilars company and subsidiary of Biocon, has announced that the U.S. Food and Drug Administration (FDA) has approved YESINTEK (Ustekinumab-kfce). The biosimilar is a monoclonal antibody designed to treat Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. The company had previously informed the Stock Exchange on 29 February 2024 about its settlement and licensing agreement with Janssen …

Express Pharma

Biocon Biologics receives FDA approval for biosimilar YESINTEK - Express Pharma

Johnson & Johnson submits applications to expand TREMFYA treatment to children with plaque psoriasis and juvenile psoriatic arthritis, backed by Phase 3 study data.

stocktitan.net

J&J Seeks FDA Approval for TREMFYA in Children with Psoriasis, Arthritis Treatment

Biocon Biologics scored an FDA approval for its Stelara biosimilar, marketed as Yesintek, the company announced Monday.
Biocon entered into a settlement and licensing agreement with Johnson & Johnson, which owns ...

Endpoints News

Biocon lands FDA approval for another Stelara biosimilar

The biosimilar is approved for the treatment of Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.

Pharmacy Times

FDA Approves Ustekinumab-kfce as Sixth Biosimilar to Stelara

Ustekinumab-kfce is planned for launch in February 2025 according to a previous settlement and license agreement with Janssen.

hcplive.com

FDA Approves Ustekinumab (STELARA) Biosimilar for Crohn’s, UC, Psoriasis, PsA

Yesintek is the latest Stelara biosimilar to gain FDA approval and it will be available in February 2025.

FDA Approves Ustekinumab Biosimilar Yesintek

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