By Catherine Jewell, Communications Division, WIPO
Kiran Mazumdar-Shaw started out as a Master Brewer and now heads up Biocon, India’s largest innovation-led biopharmaceutical company. Ms. Mazumdar-Shaw talks about what it takes to establish a multi-billion dollar global business that is transforming global healthcare and the part played by intellectual property.
I graduated as a Master Brewer from the Ballarat Brewing School in Australia in 1975. My aspiration was to pursue a professional career in brewing. I was unprepared for the hostility and gender bias I faced from the brewing industry in India. This rejection saw me turn to entrepreneurship and, quite by accident to set up a biotech start-up, Biocon, in India, where I leveraged my knowledge of fermentation to produce enzymes and biopharmaceuticals instead of beer.
No! As a 25-year-old woman with no business experience and limited financial resources, I faced huge credibility and perception challenges. In those days, women were not perceived as good entrepreneurs and biotechnology was unheard of as an industry. I dared to start a business in a male-dominated society and in a sector no one knew. The prevailing business ethos favored low-risk ventures based on services and generic drugs and was averse to risk-ridden, innovation-led businesses like biotechnology. Banks were reluctant to lend me financial support. I struggled to recruit people as professionals feared I could not provide “job security”. Suppliers told me they were unwilling to give me credit because they had no confidence in my business abilities. I succeeded against these odds because I understood that all challenges can be surmounted with perseverance and ingenuity.
Having attained success in enzymes, I used my knowledge of biotechnology to try and disrupt the healthcare industry by introducing affordable biopharmaceuticals for patients who needed them the most. These drugs, known as biologics, are developed from living biological sources, such as tissues, cells and proteins. Indeed, biosimilars are to biologics what generics are to proprietary chemically-synthesized drugs. What spurred me on this mission was the realization that a significant proportion of the world’s population does not have access to essential medicines and, where healthcare does exist, it is unaffordable. From wanting to “green the world” through eco-friendly enzyme technologies, my mission changed to “heal the world” by developing affordable life-saving drugs for patients across the globe.
Today, Biocon is India's largest, fully-integrated, innovation-led biopharmaceutical company. Our commercial footprint covers 120 countries. We invest up to 15 percent of our biopharmaceuticals business revenue in R&D. In terms of market share, our capacity to manufacture high-quality, affordable biologics puts us among the top three global biosimilar players for insulin. Up to March 31, 2017, we reported revenue of over USD 600 million and aspire to cross the USD1 billion revenue milestone by March 31, 2019.
We have a rich pipeline of novel and biosimilar assets. Biocon is committed to developing affordable therapies for unmet medical needs for chronic non-communicable diseases like diabetes, cancer and autoimmune diseases.
The ability of biologics to target, augment or modulate specific proteins and antigens makes them more effective than small molecule therapies for a variety of medical conditions. Biologic therapies such as insulin, erythropoietin and growth hormones have been invaluable in treating diabetes, anemia and renal diseases. More complex biologics like monoclonal antibodies (MAbs), cytokines and therapeutic vaccines, are transforming the standard of treatment for cancer, autoimmune disorders and other chronic diseases. Currently, 10 of the top 15 drugs by global sales are biologics. By 2020 we expect there will be new biologic treatment options for severe asthma, chronic eczema, atopic dermatitis, and familial hypercholesterolemia across developed markets. And by 2022, biologics are expected to contribute 50 percent of the value of the top 100 drug products sold globally.
Unlike small molecule drugs, novel biologics and biosimilars are large, more complex, and target specific and have stringent production protocols. The time, effort and money needed to analyze and characterize a biologic is up to four times higher than for small molecule drugs. The manufacturing process starts with fermentation, followed by a multi-step purification process. And clinical development extends beyond establishing bioavailability and bio-equivalence to include large and lengthy clinical trials and a complex regulatory approval path. The cost of developing a biosimilar is much higher than for traditional chemically-synthesized generics.
The Indian biotech sector’s ability to leverage recombinant DNA technology has enabled the delivery of genetically-engineered agricultural crops, biopharmaceuticals, vaccines and enzymes. Today, India is the world’s largest vaccine producer and its largest supplier of genetically modified cotton.
But if India is to realize its aspiration to build a USD 100 billion bio-economy by 2025, there needs to be greater synchronization of resources, plans, policies and priorities to create a self-perpetuating virtuous cycle of innovation and business growth.
As one of India’s earliest biologics players, Biocon’s innovation-led strategy has created a rich pipeline of novel and biosimilar assets. Today, we have a comprehensive portfolio of 10 disclosed and many more undisclosed molecules straddling insulin and insulin analogs, monoclonal antibodies and recombinant proteins, which address therapeutic areas of diabetes, cancer and immunology.
We are also harnessing our novel drug research capabilities to advance oral insulin and the world’s only clinically validated anti-CD6 targeting molecule to treat psoriasis in clinics. And we are also exploring the breakthrough potential of immuno-oncology to develop patient-friendly therapies against malignant tumors. Our research in this area spans many platforms and products from conventional peptides and MAbs to novel fusion MAbs and small interfering RNA (siRNA)-based therapeutics.
So far Biocon has taken two novel biologics and six biosimilars from “lab to market”. These are affordable therapies for chronic diseases.
Our crowning glory has been the approval by the United States Food and Drug Administration (USFDA) of Ogivri™, the biosimilar Trastuzumab we co-developed with Mylan, in 2017. We are the first company from India to get a biosimilar approved by the US FDA; it is also the first biosimilar Trastuzumab to be approved in the United States. This puts us in an exclusive league of global biosimilar players and means we can provide an affordable alternative cancer therapy for US patients. We launched our brand of biosimilar Trastuzumab, CANMAb™, in India, in 2014, and have since launched it in various emerging markets. Thousands of patients with HER2-positive metastatic breast cancer are now benefiting from this important drug.
In 2017 we launched, KRABEVA®, a biosimilar Bevacizumab for the treatment of metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers.
In 2016, we became the first Indian company to launch a biosimilar Insulin Glargine in Japan, after having launched it in India in 2009. Recently, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) recommended its approval in the European Union. We were, in fact, the first company in the world to commercialize recombinant human insulin (rh-insulin) manufactured through Pichia fermentation technology in 2004. We now offer a comprehensive portfolio of insulin products to millions of insulin-dependent people with diabetes across the world.
On the novel molecules front, we are pioneering the development, manufacture and launch of biologics in India. In 2006, Biocon became the first company in India to launch Nimotuzumab (BIOMAb EGFR®), a novel biologic for head and neck cancer patients. And in 2013, we launched our path-breaking anti-CD6 monoconal antibody, Itolizumab (ALZUMAb™) for psoriasis patients. Thousands of patients in India are benefitting from these affordable therapies.
Biocon’s model of innovation makes affordability a criterion of success. By leveraging the power of affordable innovation, we see “blockbuster drugs” as a means of expanding access to a billion patients. Our business model is centered on the global right to healthcare through affordable biopharmaceuticals.
IP guides Biocon’s R&D and commercialization strategy by enabling protection of our inventions and innovations. It also helps build our credibility and can allow us to benefit from a first-mover advantage. IP also enables product positioning, lifecycle management and asset monetization and valuation. Biocon has consistently created intellectual wealth through an incisive IP strategy that recognizes the innovative potential of our products and processes.
IP plays a key role in bringing innovation successfully to market and in value creation. The PCT allows innovation-led businesses like Biocon to seek patent protection in more than 150 countries through a single international patent application. As such, it is a cost-effective option. And because the costs of filing national applications are deferred by 18 months it gives us additional time to formulate our patenting and commercialization strategies for target markets.
My father, the late R.I Mazumdar, made me believe that as a woman I could achieve just as much, if not more, than any man.
Science is about making the world a better place. Knowledge has no gender. Greater participation by women in science and technology will ensure that the fruits of research are rapidly converted into useful knowledge that can support human progress. It is an important part of a nation’s social and economic development.
Diversity and inclusion are business imperatives and are embedded in Biocon’s core values. We believe a diverse workplace promotes a culture of innovation and collaboration. For us diversity is more than promoting gender balance, it is about appreciating different cultures, backgrounds, generations and ideas.
Women scientists bring diversity of thought, creativity and innovation to the table. Scientific organizations realize this and that is opening up more opportunities for women scientists. Indeed, every year, the Biocon Academy helps to bridge the gender skills gap in biotech by training significant numbers of life sciences graduates, including women.
Women are increasingly an integral part of India’s scientific community. But, it is true, relatively few women rise to leadership positions in science, technology and business because of the gender discrimination that still exists in our society. Many people still believe that marriage and family must take precedence over career. This explains the gender gap in research across disciplines. Studies show that while many women are studying science in India, few are actually doing science or pursuing careers in scientific research.
I never give up. My mantra is “Failure is temporary. Giving up is permanent.” This has helped me steer Biocon through the uncharted waters of innovation-led biotechnology research at a time when the Indian pharma industry’s focus was on manufacturing and supplying chemically-synthesized generic drugs. I have succeeded because I set out to realize my dream of making a difference to global health by delivering affordable medicines because I was appalled that a significant proportion of the world’s population lacks access to affordable medicines.
If you want to succeed in this field you need a pioneering spirit. Have the courage of your convictions and persevere in overcoming disappointments and failures. Believe in your aspirations and work with a sense of purpose to attain them.
I believe with all my heart that the healthcare industry has a humanitarian responsibility to provide affordable access to essential drug for patients who need them through the power of innovation. My vision is that our research program for diabetes and cancer care will transform treatment paradigms. We are working to develop affordable blockbuster drugs with a “Made in India” label that can benefit a billion patients around the world.
The WIPO Magazine is intended to help broaden public understanding of intellectual property and of WIPO’s work, and is not an official document of WIPO. The designations employed and the presentation of material throughout this publication do not imply the expression of any opinion whatsoever on the part of WIPO concerning the legal status of any country, territory or area or of its authorities, or concerning the delimitation of its frontiers or boundaries. This publication is not intended to reflect the views of the Member States or the WIPO Secretariat. The mention of specific companies or products of manufacturers does not imply that they are endorsed or recommended by WIPO in preference to others of a similar nature that are not mentioned.