rh-Insulin
Development of Recombinant human insulin (rh-Insulin) began in the early 2000s with a pioneering decision to use Pichia pastoris, a novel yeast-based expression system, instead of traditional platforms like E. coli or S. cerevisiae. This proprietary approach led to the launch of Insugen® in India in 2004, the world’s first rh-Insulin produced using Pichia. Over the years, Insugen® expanded to over 60 countries across Latin America, Asia, Africa, and the Middle East. Biocon also introduced INSUPen®, India’s first reusable insulin pen, and later INSUPen® EZ, improving access and patient convenience. The establishment of a large-scale integrated insulin facility in Malaysia, which received cGMP certification in 2015 and began operations in 2016, strengthened Biocon’s global footprint, with the company eventually capturing 75% of Malaysia’s insulin market. In 2020, Biocon Biologics launched Mission 10 Cents to make insulin accessible to low- and middle-income countries at less than 10 US cents per day, with early rollouts in Tanzania and the Philippines. This commitment to innovation and equitable access was recognized in 2024 when Biocon’s Pichia platform for rh-Insulin won the Prix Galien India Award for Best Medical Technology.
Early 2000s
Biocon begins development of biosimilar recombinant human insulin using a novel Pichia pastoris yeast-based expression system, an industry-first. At the time, insulin innovators were using Escherichia coli or Saccharomyces cerevisiae, with established process patents.
Biocon strategically chose Pichia, a methylotrophic yeast, to build a proprietary, unencumbered process, a bold scientific and business decision that laid the foundation for future insulin leadership.
2003
Clinical trials for rh-Insulin is initiated in India, with plans to launch the product in early 2004.
2004
Insugen® 40 IU is launched in India, becoming the world’s first rh-Insulin manufactured using Pichia pastoris. Within a month, it is launched across 11 cities in the country.
2005 - 2008
Insugen® goes on to receive approvals in several countries and is launched in Brazil, Jamaica, Costa Rica, and other emerging markets in South America, East Asia, North Africa and Middle East.
2008 - 2009
Biocon undergoes 48 successful compliance audits by national and international authorities for its rh-insulin manufacturing facility.
2010 - 2011
Insugen® is made available across Latin America, Middle East, Asia, and North Africa. Biocon is ranked 12th in India’s anti-diabetic market.
2011
Biocon expands its insulin offerings by launching 100 IU Insugen® SKUs in different variants: Insugen® R, N, 30/70, and 50/50.
Biocon begins construction of its integrated insulins facility in Malaysia.
India’s first reusable insulin pen compatible with Insugen, INSUPen® is launched, based on German technology. INSUPen® is designed for efficiency, accuracy, and patient safety, with user-friendly features and three color options to differentiate insulin types.
2012
Biocon enters the African branded formulations market with Insugen®, starting in Kenya.
2014 - 2015
rh-Insulin receives marketing approval in 60 countries
Malaysia becomes the first regulated market to approve Biocon’s generic insulin.
Biocon launches INSUPen® EZ, an affordable, second-generation reusable insulin pen, in India.
2015
Biocon’s Malaysia facility receives cGMP certification from Malaysia’s NPRA for rh-insulin drug substance and drug product.
2016
Biocon receives approvals form Ministry of Health (MOH), Malaysia for Insugen R, Insugen N and Insugen 30/70.
Commercial operations begin at Biocon’s Malaysia facility, the largest integrated insulins manufacturing facility in Asia.
2017
Insugen® is launched in new emerging markets across Africa, Latin America, ASEAN, and a CIS country.
2019
In the lead-up to the 100th anniversary of insulin, Biocon Biologics unveils ‘Mission 10 cents’, a bold access initiative to offer recombinant human insulin at less than 10 U.S. cents/day to governments in low- and middle-income countries (LMICs)
2021
Biocon expands rh-insulin sales across Latin America, Middle East, Africa, and Asia Pacific.
Mission 10 Cents is implemented in Tanzania and the Philippines.
2023
Biocon makes additional investment of USD 250 million to double drug substance and drug product manufacturing capacity at the Malaysia insulin facility to enhance global insulin access.
2024
Biocon’s Pichia platform for rh-Insulin wins the Prix Galien India Award for Best Medical Technology.
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.
