Brewing Biologics Biocon’s Kiran Mazumdar-Shaw reference

 

From brewing to biologics: Biocon’s Kiran Mazumdar-Shaw changes global health

Kiran Mazumdar-Shaw started as a winemaker and now leads Biocon, India's largest innovative biopharmaceutical company. Ms. Mazumdar-Shaw talked about how to build a multi-billion-dollar global enterprise that is changing the role of global health care and intellectual property.

 

 

Can you tell us how you came up with Biocon?

I graduated from Ballarat Brewing School in Australia in 1975 and became a winemaker. 

My wish is to pursue a career in the brewing industry. However, I am unprepared for the hostility and gender prejudice faced by the Indian brewing industry. 

This rejection made me turn to entrepreneurship and accidentally established Biocon, a new biotechnology company in India, to use my fermentation knowledge to produce enzymes and biopharmaceuticals instead of beer.

 

Have you been smooth sailing since then?

No! As a 25-year-old woman with no business experience and limited financial resources, I face huge credibility and cognitive challenges. In those days, women were not regarded as good entrepreneurs, and biotechnology as an industry was unheard of.

 I dare to start a business in a male-dominated society and a field that no one knows. The prevailing business climate tends to be low-risk companies based on services and generic drugs, and they are reluctant to start innovative companies that are risk-ridden like biotechnology. 

The bank is unwilling to lend me financial support. As professionals worry that I cannot provide "job security", I work hard to recruit people. The supplier told me that they were unwilling to give me credit because they did not have confidence in my ability to operate. 

I successfully overcome these difficulties because I understand that all challenges can be overcome with perseverance and originality.

 

What prompted you to move into the biopharmaceutical field?

After my success with enzymes, I used my biotechnology knowledge to try to influence the health care industry by introducing affordable biopharmaceuticals to patients who need them most. These drugs, called biologics, are developed from living biological sources (such as tissues, cells, and proteins). 

In fact, from biosimilars to biological preparations, as from generics to patented chemically synthesized drugs. What motivated me to accomplish this task was the realization that a considerable part of the world’s population does not have access to essential medicines and cannot afford them when health care exists. 

From wanting to "green the world" through environmentally friendly enzyme technology, my mission became to "cure the world" by developing affordable, life-saving drugs for patients all over the world.

 

Today, Biocon is India's largest fully integrated innovative biopharmaceutical company. Our business footprint covers 120 countries. We invest 15% of the operating income of biopharmaceuticals into research and development. 

In terms of market share, our ability to manufacture high-quality, affordable biologics puts us among the top three global insulin biosimilars. As of March 31, 2017, we reported more than $600 million in revenue and are expected to cross the $1 billion revenue milestone by March 31, 2019.

 

What is the current focus of your biologics project?

We have a series of new biosimilar assets. Biocon is committed to developing affordable treatments for the unmet medical needs of chronic non-communicable diseases such as diabetes, cancer and autoimmune diseases.

 

Biocon's campus in Bangalore. The company recently opened a manufacturing center in Johor, Malaysia.

Biocon is using the power of biotechnology to improve the access to affordable essential medicines for patients with chronic diseases.

What are the advantages of biological agents over traditional treatments?

The ability of biological agents to target, enhance or modulate specific proteins and antigens makes them more effective than small molecule therapies under various medical conditions. 

Biological therapies such as insulin, erythropoietin and growth hormone are of inestimable value in the treatment of diabetes, anemia and kidney disease. More complex biological agents such as monoclonal antibodies (MAbs), cytokines and therapeutic vaccines are changing the standard of treatment for cancer, autoimmune diseases and other chronic diseases. 

Currently, 10 of the top 15 drugs sold globally are biologics. By 2020, we expect new biological treatments for severe asthma, chronic eczema, allergic dermatitis and familial hypercholesterolemia will appear in developed markets. By 2022, biologics are expected to account for 50% of the value of the top 100 drugs sold globally.

 

Different from small-molecule drugs, new biologics and biosimilars are large in volume, more complex, targeted specifically, and have strict production procedures. The time, effort, and money required to analyze and characterize biological agents are four times higher than that of small molecule drugs. 

The manufacturing process starts with fermentation, followed by a multi-step purification process. In addition to determining bioavailability and bioequivalence, clinical development also includes large and long-term clinical trials and complex regulatory approval pathways. 

The cost of developing biosimilars is much higher than that of traditional chemically synthesized generics.

 

Can you talk about the role of innovation in Indian biotechnology?

The Indian biotechnology sector's ability to use recombinant DNA technology makes it possible to provide genetically engineered crops, biopharmaceuticals, vaccines and enzymes. Today, India is the world's largest vaccine producer and largest supplier of genetically modified cotton.

 

Biocon invests 15% of its annual revenue in research and development. It creates a collaborative atmosphere that allows creativity and collaborative research to flow freely, thereby encouraging innovation. 

The company recognizes innovators through a series of incentives, rewards and bonuses. 

But if India is to realize its aspiration to build a $100 billion bioeconomy by 2025, it needs to strengthen the coordination of resources, plans, policies, and priorities to create a self-sustaining virtuous circle of innovation and corporate growth.

 

As one of the earliest biologics companies in India, Biocon's innovation-led strategy has created a series of new biosimilar assets. Today, we have a comprehensive portfolio of 10 published and more undisclosed molecules including insulin and insulin analogs, monoclonal antibodies and recombinant proteins, which are involved in the treatment of diabetes, cancer and immunology.

We also use our new drug research capabilities to promote oral insulin and the world's only clinically validated anti-CD6 targeting molecule to treat psoriasis in the clinic. 

We are also exploring the breakthrough potential of immuno-oncology and developing harmless treatments for patients with malignant tumors. 

Our research in this field spans from many platforms and products of traditional peptides and monoclonal antibodies to therapies based on novel fusion monoclonal antibodies (MAb) and small interfering ribonucleic acid (siRNA).

 

Tell us more about some of your breakthrough innovations.

So far, Biocon has introduced two new biologics and six biosimilars from the laboratory to the market. They are affordable treatments for patients with chronic diseases.

 

Our highest honor is the U.S. Food and Drug Administration (USFDA) approval of Ogivri ™, the biosimilar trastuzumab that we co-developed with Mylan in 2017. We are the first Indian company to obtain a biosimilar approved by the U.S. Food and Drug Administration; it is also the first biosimilar trastuzumab approved in the United States. This brings us into the global alliance of biosimilar experts, which means that we can provide American patients with affordable alternative cancer therapies. 

We launched our branded biosimilars Trastuzumab and CANMAb ™ in India in 2014 and have since launched them in multiple 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 rectal cancer and other types of lung cancer, kidney cancer, cervical cancer, ovarian cancer and brain cancer.

 

In 2016, we became the first Indian company to launch the biosimilar insulin glargine in Japan, which was launched in India in 2009. Recently, the European Medicines Agency's Committee for Medicines for Human Use (CHMP) recommended that the European Union approve it. 

In fact, we are the first company in the world to commercialize recombinant human insulin (rh-insulin), which was produced in 2004 through the use of Pichia yeast fermentation technology. We now provide a comprehensive portfolio of insulin products to millions of insulin-dependent patients with diabetes worldwide. 

Translating breakthrough laboratory discoveries into clinical success is a major challenge facing the global biopharmaceutical industry. Therefore, Biocon is strengthening its scientific research and development team and participating in strategic cooperation to further improve its effectiveness in this field.

 

At the forefront of new molecules, we are developing, producing and launching biologics in India. In 2006, Biocon became the first company in India to launch Nimotuzumab (BIOMAb EGFR®), a new type of biologic for patients with head and neck cancer. 

In 2013, we launched the pioneering anti-CD6 monoclonal antibody itolizumab (ALZUMAb™) for patients with psoriasis. Thousands of patients in India are benefiting from these affordable therapies.

 

What motivates Biocon to commit to affordable health care?

Biocon's innovative model makes payment ability a success criterion. By leveraging the power of affordable innovation, we view “best-selling drugs” as a way to expand access to one billion patients. Our business model focuses on the right to global healthcare, which is achieved by providing affordable biopharmaceuticals.

 

What role does intellectual property play in your business?

Intellectual property rights guide Biocon's R&D and commercialization strategy by protecting our inventions and innovations. This also helps build our credibility and allows us to benefit from first-mover advantage. Intellectual property also supports product positioning, life cycle management, and asset monetization and evaluation. 

Biocon continues to create wealth of knowledge through an aggressive intellectual property strategy, which recognizes the innovative potential of our products and processes.

 

What are the benefits of using WIPO's Patent Cooperation Treaty (PCT)?

Intellectual property plays a key role in bringing innovation to the market successfully and creating value. The PCT allows innovation-led companies like Biocon to seek patent protection in more than 150 countries through an international patent application. Therefore, this is a cost-effective option. And because the cost of submitting a national application was delayed by 18 months, this gave us more time to formulate a patent and commercialization strategy for the target market.

 

Why is it important for women to engage in science and technology?

My father, the late R.I Mazumdar, convinced me that as a woman, if I did not achieve more than men, I could achieve the same.

 

Science makes the world a better place. Knowledge has no gender. Increased participation of women in science and technology will ensure that research results are quickly translated into useful knowledge that can support human progress. This is an important part of the country's social and economic development.

 

Diversity and inclusion are corporate rules and are embedded in Biocon's core values. We believe that a diverse work environment will promote a culture of innovation and collaboration. For us, diversity is not only to promote gender balance, but more importantly, to appreciate different cultures, backgrounds, generations and ideas.

 

Female scientists bring diversity of thought, creativity and innovation. Scientific organizations realize this and open up more opportunities for women scientists. In fact, Biocon Academy helps close the gender skills gap in the biotechnology field by training many life science graduates (including girls) every year.

The development of biopharmaceuticals (biologics and biosimilars) is a complex process that requires strict production agreements. The clinical development of biological drugs is much more expensive than traditional chemical synthetic generic drugs. (Photo: provided by Biocon).

Women are increasingly becoming an integral part of the Indian scientific community. However, because gender discrimination still exists in society, relatively few women are promoted to leadership positions in science, technology, and business. 

Many people still believe that marriage and family must take precedence over occupation. This explains the gender gap in interdisciplinary research. Studies have shown that although many women study science in India, few are engaged in science or scientific research.

 

What is the secret of your success?

I never give up. My mantra is "Failure is temporary. Giving up is permanent." When the Indian pharmaceutical industry focused on the manufacture and supply of chemically synthesized generic drugs, my mantra helped me guide Biocon in the unknown field of innovation-led biotechnology research. 

I succeeded because I am committed to my dream of changing global health by providing affordable medicines, and also because I am shocked that a large part of the world’s population lacks access to affordable Opportunities for drugs.

 

What advice do you have for women?

If you want to succeed in this field, you need a pioneering spirit. Have the courage to strengthen your convictions and persist in overcoming disappointments and failures. Believe in your wishes and work with goals to achieve these goals.

 

What are the future plans?

I fully believe that the healthcare industry has a humanitarian responsibility to provide affordable essential medicines to patients in need through the power of innovation. My vision is that our diabetes and cancer care research program will change the treatment model. We are working hard to develop affordable, best-selling drugs with the "Made in India" label that will benefit one billion patients worldwide.

References:

1. https://www.wipo.int/portal/en/index.html