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Biocon Biologics Gains Approval to Launch Bmab 1200 in Europe, UK, Canada, and Japan

02 Sep 2024
Admin
News Article

Biocon Biologics Gains Approval to Launch Bmab 1200 in Europe, UK, Canada, and Japan

Overview

Biocon Biologics announced today that it has signed a settlement and license agreement with Janssen Biotech, Janssen Sciences, and Johnson & Johnson.

About Stelara

Stelara® (Ustekinumab) is a monoclonal antibody used to treat conditions such as psoriasis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis by targeting interleukin IL-12/23.
In 2023, Stelara® generated global sales of $10.85 billion.

About Agreement

This agreement allows Biocon to commercialise its proposed biosimilar Bmab 1200, similar to Stelara®, in Europe, the United Kingdom, Canada, and Japan.
The agreement resolves patent disputes with Janssen and provides Biocon Biologics with confirmed market entry dates in these regions.
The regulatory filings for Bmab 1200 in these markets are currently under review.

Settlement in the US

Previously, Biocon Biologics reached a settlement in the United States, securing a potential launch for Bmab 1200 no later than 22 February 2025, subject to approval by the U.S. Food and Drug Administration (FDA).

FDA review- The FDA is currently reviewing the Company’s Biologics License Application (BLA) for Bmab 1200 under the 351(k) pathway.

Biocon Biologics' Commitment

This agreement highlights Biocon Biologics' commitment to scientific innovation and marks a significant milestone in bringing Bmab 1200 (bUstekinumab) to global markets.

The biosimilar Bmab 1200 will enhance the Company’s immunology portfolio, offering a cost-effective treatment option for patients with autoimmune diseases.