On July 15, 2016, Biocon Ltd. announced the launch of a high quality, yet affordable biosimilar version of Sanofi’s blockbuster Lantus drug for patients of diabetes in Japan.
Lantus, or Insulin Glargine, is a biologic. In contrast to conventional drugs that are synthesized from chemicals, a biologic is manufactured in a living system such as a microorganism or plant or animal cells. Most biologics are large, complex molecules and are produced using recombinant DNA technology. Biologics are one of the most significant developments of modern science as they potentially offer the most effective means to treat a variety of medical conditions that presently have no other treatments available.
Biologic therapies such as insulin, erythropoietin and growth hormones have played an invaluable role in treating serious illnesses such as diabetes, anemia and renal diseases. More complex biologics like monoclonal antibodies (MAbs), cytokines and therapeutic vaccines, are now transforming the standard of treatment for cancer, autoimmune disorders and other chronic diseases.
It is expected that by 2020 new biologic treatment options will be available for conditions like severe asthma, chronic eczema, atopic dermatitis, and familial hypercholesterolemia across developed markets. It has been seen that 10 of the top 15 drugs globally were Biologics in 2016.
A biosimilar is the biopharmaceutical equivalent of a generic drug and is designed to have active properties similar to one that has previously been licensed. The approval for Insulin Glargine in Japan marked the foray of Biocon’s first biosimilar product into the developed markets. It was a significant milestone for Biocon, Asia’s premier biopharmaceutical company, which has been a forerunner in bringing the benefit of high quality, yet affordable, novel biologics and biosimilars to patients in India and other emerging markets.
The Japan launch of Insulin Glargine was also a significant achievement as it shattered the myth that Indian biopharmaceutical companies did not have the capabilities and quality strengths needed to take ‘Made in India’ biologics to highly regulated, developed markets.
The launch of Insulin Glargine in Japan, which has high entry barriers in terms of product quality and regulatory compliances, marked a huge credibility milestone for Biocon and endorsed the quality of its products, its expertise in developing complex biologics and its robust GMP compliant eco-system.
Kiran Mazumdar-Shaw: Game changer
Biocon’s feat did not come as a surprise for those who have followed the career of the company’s founder chairperson, Kiran Mazumdar-Shaw.
The only Indian on Forbes’ latest list of “World’s Self-Made Women Billionaires,” Kiran Mazumdar-Shaw is a pioneer of the biotechnology industry in India who has made India proud by building a globally recognized biopharmaceutical enterprise that is committed to innovation and affordability in delivering best-in-class therapeutics to patients across the globe.
Under Kiran Mazumdar-Shaw’s stewardship, Biocon pursued a risk-ridden, innovation-led business such as biotechnology when the prevailing business ethos of the Indian pharma industry favored low-risk ventures based on generics and services.
Biocon is today India’s largest publicly listed biopharmaceutical company. The company has the largest scientific talent pool in India, and is engaged in path-breaking research to develop novel and differentiated biopharmaceuticals aimed at reducing the cost of treatment for cancer, diabetes and autoimmune disorders for patients worldwide.
For her multifaceted contributions to biotechnology, innovation, entrepreneurship, research, and philanthropy, Kiran Mazumdar-Shaw has been honored with many national and international awards. She has recently been appointed “Knight of the National Order of the French Legion of Honor” by the government of France for her outstanding contribution to the world of biosciences. She has several other global recognitions to her credit such as the “Othmer Gold Medal” awarded by the Chemical Heritage Foundation, USA, and the “Global Economy Prize for Business” given by the Kiel Institute for the World Economy, Germany.
But more importantly, Ms. Mazumdar-Shaw is the proud recipient of two of India’s highest civilian honors – the Padma Bhushan (2005) and the Padma Shri which she received as early as in 1989.
Named among TIME magazine’s 100 most influential people in the world, she is recognized as a global thought leader. Since 2010, she has been on Forbes’ list of 100 most powerful women in the world.
She has also featured in ‘The Worldview 100 List’ of the most influential visionaries by Scientific American magazine and has been named among the ‘100 Leading Global Thinkers’ by Foreign Policy magazine in 2014. She was ranked second among the 100 Most Influential People in the field of medicine in the ‘Global Medicine Maker Power List 2015’ published by a top UK-based medical publication.
Her commitment to affordable healthcare extends beyond business. Her philanthropic initiatives are directed at making a difference to the lives of the marginalized communities.
She has established the 1,400-bed Mazumdar-Shaw Cancer Center at NH City in Bangalore to deliver affordable world-class cancer care services to patients irrespective of socio-economic status.
She has also set up the Mazumdar Shaw Center for Translational Research, a non-profit research institute dedicated to developing scientific breakthroughs for treating a wide range of human diseases.
Kiran commitment to philanthropy is reflected in her signing the “Giving Pledge” – a global initiative created by Warren Buffett and Bill and Melinda Gates that encourages billionaires to give the majority of their wealth to philanthropic causes. She is the Second Indian to join the Giving Pledge group.
Her philanthropic efforts have led her to be featured in the Forbes’ List of ‘Heroes of Philanthropy’. She was also given the ‘Wockhardt Foundation Philanthropist Popular Award’ on National Philanthropy Day in 2016.
An Employer of Choice
With an inspirational leader as Kiran Mazumdar-Shaw at the helm, it’s not surprising that Biocon is today well-recognized as India’s most preferred biotech employer and is highly regarded by the scientific community in the US and Europe.
The company’s ability to attract the best talent, nurture and build an engaged workforce and harness a performance-driven culture have been instrumental in building this image. The current age profile in Biocon consists of 57% individuals younger than 30 years of age and 40% individuals in the age group of 31-45. With a young workforce at its disposal, Biocon looks to break new grounds in research and innovation. Of the 8000 employees at Biocon, over 4000 are scientists and more than 30% of these are women, which speaks for the gender diversity and merit based work philosophy at Biocon.
Biocon prides itself on creating an ecosystem that encourages a collegial atmosphere conducive to free flow of ideas and collaborative research. It has a strong pool of employees who have finished their PhDs from prestigious American and European institutions and decided to join Biocon to contribute their expertise in developing a world class scientific organization.
In 2016, Biocon was ranked among the world’s Top 10 BEST Employers in Biotechnology by the prestigious US-based magazine Science. The company was the only one from Asia to feature on this prestigious list. According to the comprehensive 2016 Web-based survey of nearly 6,000 respondents, Biocon’s ranking is based on key attributes such as ‘innovative leader in the industry’, ‘is socially responsible’, and ‘has a clear vision.’ Biocon has consistently been a part of this elite group for the past several years.
Investing in Cutting-Edge R&D
Biocon’s reputation as ‘innovative leader in the industry’ is fueled by prudent investments in R&D in line with its core philosophy of making high quality affordable medicines. It is recognized as one of the highest R&D spenders in the country with an average of 12-15% of its revenues compared to the national industry average of 5-8%. In quest of their objective of enhancing global healthcare through innovative and affordable Biopharmaceuticals, Biocon’s Research and Development function has built world-class competence and capability on the back of robust infrastructure and a talent pool that has extensive global product development experience. Biocon has filed for more than 1200 patent applications globally out of which nearly 1000 patents have been granted. It has nearly 450 trademark registrations to its name.
Biocon’s core strategy on R&D is based on integrated discovery, stage gated approach to development, core disease area expertise (autoimmune and inflammation, oncology and diabetes), and a first-rate scientific advisory board.
Biocon is today well positioned to achieve its long cherished objective of providing affordable access to transformative, life saving biopharmaceuticals for patients across the globe.
Biocon: Talking the Road Less Travelled
However, the journey to becoming India’s largest Biotech company and one of the leading Asian biopharmaceutical companies has been an arduous one. Biocon faced severe infrastructural and technological hurdles in its journey, but surmounted it with determination and an innovative spirit. Biocon started off in 1978 as an enzyme maker seeking to disrupt industrial processes by manufacturing environment-friendly enzymes to replace polluting chemical technologies. Enzyme manufacturing for industrial application involved sophisticated fermentation process which demanded an uninterrupted power supply and precision process control. At that time, power supply was erratic at best, there was little access to superior quality water and importing high-end research equipment was difficult due to procedural hurdles. To tide over some of these challenges, Biocon indigenously developed an innovative fermentation technology, which offered considerable savings in terms of equipment, floor space, energy and manpower. This patented technology was a commercial and technological breakthrough that could produce superior enzymes with higher productivity. It gave Biocon’s products an edge over enzymes produced by western biotechnology companies.
In time, the company leveraged this patented technology to emerge as India’s largest enzyme manufacturer and exporter.
Though Biocon had achieved remarkable success in enzymes, Kiran Mazumdar-Shaw had a much larger goal ahead for the organization. She wanted to leverage Biocon’s expertise in fermentation technology to develop biopharmaceuticals that would provide an affordable solution to the huge challenge of chronic diseases faced by in India and the developing world, which had little access to expensive therapies.
Biocon first leveraged its proprietary technology to develop cholesterol reducing drugs called Statins. In 2001, Biocon became the first Indian company to be approved by the US FDA for the manufacture of cholesterol-lowering molecule Lovastatin. Since then the company has emerged as the world’s largest statins manufacturer, with its drug substance being used to produce ‘one in every three’ statin pills globally.
It then leveraged its genetically engineered technology based on a yeast—Pichia pastoris—to develop Recombinant Human Insulin and Biocon launched INSUGEN® as India’s first indigenously developed rh-Insulin in 2004, at a fraction of the price of imported insulins marketed by MNCs.
For Biocon, 2004 was also significant because it was the year it decided to approach the capital markets. Biocon was the first Biotechnology company in India to go public and its IPO was oversubscribed 32 times, which created a milestone on day 1 as its stock closed with a market value of over a billion dollars. The market gave Biocon a premium valuation because they were spearheading a new technology sector – “Biotechnology.” As a pioneering innovation-led biopharma enterprise, Biocon was among the first in India to invest in developing recombinant DNA and bio-processing technologies that could deliver innovative and affordable biologics. Today, Biocon is the largest biotechnology company listed on India’s stock exchanges!
In 2007, Biocon sold its enzymes business to Novozymes for USD 115 million to focus on biopharmaceuticals.
In 2009, Biocon introduced BASALOG® its version of Insulin Glargine, a long-acting insulin analog, in the Indian market. Biocon thus helped India reduce its dependence on expensive imported insulins by introducing affordable versions of high quality, ‘Made in India’ insulins. Since then Biocon has built global scale for insulins and is today among the Top 3 biosimilar players in both Human Insulin and Insulin Glargine globally. Thanks to the pioneering efforts of Biocon, prices of insulin in India are among the lowest in the world.
As the largest Asian insulins player and the fourth largest producer of insulins in the world, Biocon’s aim over the next 10 years is to provide their insulin products to ‘one in five’ diabetes patients in need of insulin-based therapy anywhere in the world.
The launch of India’s first indigenously produced novel antibody BIOMAb EGFR® in 2006 earned Biocon recognition as a leading Indian Oncology Company. This reputation was further strengthened through CANMAb™, which is the first biosimilar Trastuzumab to be approved anywhere in the world. Biocon is now poised to take this key cancer drug to developed markets such as EU and US.
The 2013 launch of ALZUMAb™ also brought Biocon global attention as the first and only company globally to clinically validate CD6 as a target for autoimmune diseases.
Having developed and launched five biosimilars and two novel biologics for the benefit of patients in India, Biocon is now leveraging that experience to take a robust portfolio of biosimilars to a global patient population. The company possess one of the largest global biosimilars portfolios, spanning human insulin, insulin analogs, recombinant proteins and antibodies.
Biocon is also harnessing its capabilities in novel biologics research to advance an exciting Oral Insulin and the world’s only clinically validated anti-CD6 targeting molecule through the clinics. The company is exploring the breakthrough potential of immuno-oncology to develop patient-friendly therapies against malignant tumors. Its novel programs span a wide range of platforms and products from conventional peptides & antibodies to novel fusion antibodies and small interfering RNA (siRNA) based therapeutics.
Biocon has harnessed the potential of Biotechnology to increase affordable access to highly complex biopharmaceuticals like Insulins and Antibodies for the benefit of patients in India first and subsequently the world over.
Biocon today has grown to be a company with over 8,000 employees that generated revenues of Rs. 35,699 million as of financial year ended March 31, 2016.
Going Beyond Business
Biocon believes its mission of ensuring access to affordable healthcare goes beyond developing new medicines to taking the ‘Right to Healthcare’ to less advantaged, rural communities in India. Executing their corporate-social responsibility through the Biocon Foundation, they have adopted an integrated outreach strategy that focuses on social change and empowerment of rural communities through public health, sanitation and education programs.
Biocon Foundation is leveraging the power of technology in enabling the transformation of the public healthcare scenario in India, particularly in rural and remote areas. The foundation has implemented its e-healthcare telemedicine initiative through its unique eLAJ clinics, equipped with multi parameter monitors (MPM) to deliver evidence based healthcare for the benefit of communities with poor access to quality healthcare in Karnataka and Rajasthan. eLAJ clinics are staffed with doctors, technicians and pharmacists who are trained to handle sophisticated diagnostic equipment and clinic management software which also creates electronic medical records of the patients. This eLAj model can be leveraged for long-term health tracking which can facilitate effective preventive and primary healthcare interventions.
Awards and Accolades in 2016
Featured in Asia IP Elite 2016 List, the only pharma Company from India.
Awarded “Best Biotech Patents Award” by Indian Drugs Manufacturers Association.
“ABIDE,” Biocon’s Novel Diabetes Education Initiative for Medical Practitioners, awarded by RSSDI.
Won Frost & Sullivan India Best Practices Award 2016 for “Biotechnology Company of the Year”.
Won CII Excellence Award for best EHS practices in Pharma.
Mission: “To be an integrated Biotech enterprise of global distinction.”
Vision: “To enhance global healthcare through innovative and affordable Biopharmaceuticals for patients, partners and healthcare systems across the globe.”