Biocon Limited has announced the launch of its Glucagon-like Peptide-1 (GLP-1) drug Liraglutide in the Netherlands following approval from the Dutch Medicines Evaluation Board (MEB), marking a significant expansion of the company's peptide portfolio in European markets. This launch represents Biocon's first entry into the European Union market with Liraglutide under its own brand names.

Product Launch Details

Biocon has partnered with Pharmamedicb B.V. as its distribution partner to introduce the drug-device combination for two key therapeutic areas in the Netherlands.

Therapeutic Applications

Liraglutide will serve dual therapeutic purposes in the Dutch market:

1. For diabetes management: Marketed as gVictoza under the brand name Diavorin®.
2. For obesity treatment: Available as gSaxenda under the brand name Vobexoryn® for chronic weight management.

Strategic Significance

This launch is a significant milestone in Biocon's global expansion strategy. It showcases the company's vertically integrated, end-to-end capabilities that enable it to deliver high-quality, affordable metabolic treatments at scale. The introduction of Liraglutide in the Netherlands demonstrates Biocon's scientific and manufacturing excellence while underlining its commitment to broadening access to advanced therapies for diabetes and obesity.

About GLP-1 and Liraglutide

Glucagon-like peptide-1 (GLP-1) medications help lower blood sugar levels and promote weight loss. These physiological hormones have multiple actions on glucose, mediated by GLP-1 receptors released from gut enteroendocrine cells. They control meal-related glycemic excursions through augmentation of insulin and inhibition of glucagon secretion.

Liraglutide also inhibits gastric emptying and food intake actions, maximizing nutrient absorption while limiting weight gain. The drug was approved by the US FDA in 2014 and by the EMA a year later for adults who are either obese or overweight with at least one weight-related condition.

Distribution Partnership

Pharmamedicb B.V., Biocon's distribution partner for the Netherlands launch, is a leading supplier of generic drugs in the Dutch market. The company leverages its extensive knowledge of local market dynamics to source high-quality generic medicines. Pharmamedicb focuses on unique and specialized products within niche segments and acts as a bridge between international manufacturers and Dutch healthcare providers.

This launch marks an important step for Biocon in expanding its presence in the European market and reinforces its position as a global player in the biopharmaceutical industry.

Biocon Biologics Limited has announced a comprehensive settlement and license agreement with Regeneron and Bayer for the worldwide commercialization of its biosimilar aflibercept, YESAFILI. This strategic agreement follows an earlier settlement covering the United States and Canada, establishing clear pathways for global market entry.

Agreement Details and Global Market Access

The settlement agreement with Regeneron and Bayer enables Biocon Biologics to commercialize YESAFILI, a biosimilar aflibercept (40mg/ml), across all countries worldwide. The agreement dismisses all pending litigation between the parties, clearing regulatory and legal obstacles for market entry.

Product Profile and Therapeutic Applications

YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor designed to treat multiple ophthalmology conditions. The biosimilar has received regulatory approval from both the European Commission (EC) and the Medicines Healthcare products Regulatory Agency (MHRA).

Launch Timeline and Market Entry Strategy

The phased launch approach begins with the United Kingdom market in January 2026, followed by other settled countries in March 2026 or earlier under certain circumstances. Biocon Biologics previously secured market entry for the U.S. in April 2025, with launch planned for the second half of calendar year 2026.

The company has already launched YESAFILI in Canada earlier this year, with market entry secured in March 2024. This global settlement expands Biocon Biologics' presence in the ophthalmology therapeutic area as part of its strategy to increase patient access worldwide.

Strategic Significance for Biocon Biologics

According to Shreehas Tambe, CEO & Managing Director of Biocon Biologics, "This settlement paves the way for Biocon Biologics to make available our biosimilar Aflibercept globally. This milestone expands our presence in the ophthalmology therapeutic area as we work closely with healthcare systems to increase access to patients everywhere."

The agreement represents a significant addition to Biocon Biologics' portfolio of 10 commercialized biosimilars, which currently serve over 6.30 million patients across 120 countries. The company maintains a pipeline of 20 biosimilar assets across diabetology, oncology, immunology, ophthalmology, bone health and other non-communicable diseases.