Glargine
2000-05
Early Development Initiation Biocon leverages its fermentation technology strengths to initiate an insulin development program, laying the groundwork for future biosimilar insulin products.
2006-09
2009
2010-12
2013
Biocon enters into a co-development partnership for insulin analogs for global markets with Mylan (now Viatris).
Global clinical trials for Insulin Glargine begin with the INSTRIDE study.
2015
Basalog One, a prefilled disposable Insulin Glargine pen, is launched in India.
Biocon’s Insulin Glargine becomes the first biosimilar to be approved in Mexico under the country’s biologics pathway defined in 2012.
2016
2018
2020
U.S. FDA approval for Semglee makes Biocon Biologics the first company to have approvals on both the vial and pen presentations of biosimilar Insulin Glargine.
Semglee® is launched in vial and prefilled pen presentations in the U.S., and offered at the lowest wholesale acquisition cost (WAC) for any long-acting biosimilar Insulin Glargine on the U.S. market.
2021
Semglee® receives historic U.S. approval as the world’s first interchangeable biosimilar product.
Branded and unbranded versions of interchangeable biosimilar Insulin Glargine are launched in the U.S.
2023
Approved as a biosimilar to Lantus®, bGlargine represents a key milestone in Biocon’s insulin development journey, which began in 2002. The product was first introduced in India in 2009 under the brand name Basalog®, strengthening access to affordable diabetes care in the domestic market. Its subsequent approval and launch in Japan in 2016 marked Biocon’s first entry into an ICH region and its emergence as a credible global insulins player. Semglee® is also the first biosimilar in our portfolio to receive approvals across all ICH regions, including the first interchangeability status in U.S.
