Biocon arm, Mylan launch diabetes drug Semglee in US

Biocon Biologics India and Mylan NV have launched the product in a vial and pre-filled pen presentations in the US, Biocon said in a statement.

Semglee, which has received final approval from the US Food and Drug Administration (FDA), has an identical amino acid sequence to Sanofi''s Lantus, a drug used to control high blood sugar, it added.

"The commercialization of our insulin glargine in the US represents another milestone achievement for Biocon in making insulin-based therapy increasingly accessible for people with diabetes globally," Biocon Executive Chairperson Kiran Mazumdar-Shaw said.

The company is confident that along with its long-standing partner Mylan, it will be able to address the needs of millions of patients living with diabetes in the US, she added.

Biocon has been expanding affordable access to biosimilar insulins to patients in Japan, Australia, Europe, India, and key emerging markets, Shaw said.

"The US launch of Semglee takes us closer to realizing our aspiration of reaching ''one in five'' insulin-dependent people with diabetes worldwide," she added.

Biocon Biologics CEO Christiane Hamacher said the company's focus on developing and manufacturing global quality insulins enables it to address the growing needs of diabetes patients.

"We believe the US market represents a great opportunity for us and expect Semglee to contribute significantly to our goal of impacting 5 million patients'' lives and achieving USD 1 billion revenue by end of FY22," he added.

Mylan and Biocon Biologic''s insulin glargine has received regulatory approval in more than 45 countries and is the third product approved by the FDA through the Mylan-Biocon Biologics collaboration.