By Kiran Mazumdar Shaw, CMD, Biocon

The approval of our biosimilar Trastuzumab by the U.S. FDA is a vindication of our two-decade-long biologics-led pharmaceutical journey. We had invested ‘ahead of the curve’ in the promising future of targeted biologics at the turn of the millennium. At that time, we had anticipated some of the risks, the evolving regulatory landscape and significant financial outlay for R&D and manufacturing infrastructure. Yet, we decided to take on the complex development, manufacturing and regulatory challenges inherent to biologics as we were confident of our capabilities.

This approval is thus a huge validation of the strength of our science, quality of our teams and our ability to execute science programs for hard-to-make and complex products like biosimilars. Bringing such complex products to the market requires sound and advanced scientific research, Chemistry, Manufacturing, and Controls (CMC) capabilities, talented research and development teams and biotech engineers for scale up and manufacturing.

Biocon has nurtured a pool of highly talented scientists who are experts in their fields, ranging from bioengineering, molecular biology, analytical science, clinical science, regulatory science and intellectual property management.

The combination of high technology, talent, and a culture of deep science at Biocon has culminated in the approval of the first biosimilar from India in the US.

A Long & Eventful Journey

We started work on the Trastuzumab molecule in 2008. Biosimilars require the confluence of multiple high-end skills due to the complexity involved in bioprocess development and significant investments in sophisticated manufacturing infrastructure including aseptic processing. Besides robust research & development and manufacturing capabilities, the ability to manage legal and regulatory complexities is essential for successful commercialization of biosimilars. To mitigate some of these risks we entered into a global partnering agreement with Mylan for biosimilar monoclonal antibodies and other recombinant proteins in 2009. This partnership, structured as a sharing of risks and rewards, leveraged the complementary strengths of each partner and was a forerunner to many global partnerships that exist today in the biosimilar space.

Through our joint efforts we generated robust data from the structural and functional characterization of the Trastuzumab molecule using multiple orthogonal techniques, nonclinical studies and pharmacokinetic evaluation in healthy subjects and patients and a safety, efficacy and immunogenicity study in relevant patient populations, which compared our biosimilar Trastuzumab, to the innovator product. The data demonstrated that our biosimilar Trastuzumab is highly similar to the reference product and no clinically meaningful differences exist between them in terms of safety, purity and potency. In July 2017, the FDA Oncologic Drugs Advisory Committee (ODAC) recommended approval of our biosimilar Trastuzumab through a unanimous 16-0 vote

After nine years of blood, sweat and tears, Biocon and Mylan finally earned the distinction of being the first to receive an US FDA approval for a biosimilar to Herceptin® (trastuzumab), a drug for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer which generates sales of almost US$7 billion globally.

Our jointly developed product is the first biosimilar from Mylan and Biocon’s joint portfolio approved in the US. Most importantly, it is the first biosimilar from India to be approved in the US.

This approval has proved that as an organisation, as people, we have what it takes to make world class, cutting-edge biologics. We have proved that we can take on some of the most complex challenges and be triumphant. We have proved that ordinary people can do extra-ordinary things. We have proved to the world that our scientists, our researchers, our engineers and everyone that is required to make a success of biosimilars are second to none! We have delivered on the promise of ‘Made in India for the world’.

We are proud of the fact that we have put India among the frontrunners in the global biosimilars race.

Patients Will Benefit From Our Triumph

But beyond all of this, this single event is going to make a big difference to global healthcare. Ultimately, patients are going to benefit from our triumph!

Biologic drugs, like trastuzumab represent a large and increasing portion of the overall prescription drug market. They are important in the fight against many chronic and life-threatening diseases, including cancer. However, these drugs can cost far more than traditional prescription drugs, and their cost can prohibit access.

Our biosimilar Trastuzumab will expand patient access to a more affordable treatment for HER2-overexpressing breast cancer and metastatic stomach cancer and deliver significant savings to the U.S. healthcare system. It will bring to a larger patient pool a new generation of targeted therapies that have radically changed the way the cancer is treated.

In the U.S., an estimated 250,000 new cases of female breast cancer and 28,000 new cases of stomach cancer are expected to be diagnosed in 2017 alone. Approximately 20% to 25% of primary breast cancers are HER2-positive.

Worldwide, nearly 1.7 million women are diagnosed with breast cancer each year, making it the second most common cancer in the world. However, biologic drugs like Trastuzumab are beyond the reach of most people in the developing world.

Across the world, 5.1 billion people have little or no access to modern medicine. Biologics are a class of modern medicines that very, very few people in the world could afford till now and Biocon is aiming to change that paradigm.

We want to make this drug available to a larger number of patients around the world. Not just in the developed world but in the developing world. Our aspiration is to make biosimilar Trastuzumab available to one in 10 patients of HER2-overexpressing breast cancer.

Remember, we were the first to launch the world’s first biosimilar Trastuzumab in India in 2014 at a price significantly lower than the originator brand. Patients suffering from HER2-positive metastatic breast cancer in India gained access to an affordable version of this lifesaving drug when the rest of the emerging world only had recourse to the expensive innovator product. CANMAb™, our biosimilar Trastuzumab brand, has helped treat several thousand HER2-positive metastatic breast cancer patients in India since its launch and has helped the overall expansion of the market which is reflected in nearly 25% volume growth witnessed by this molecule since launch.

The Road Ahead

This is the start of a very exciting journey ahead! It is an important milestone in our journey of developing advanced therapies that have the potential to benefit billions of patients. We have a lot to do. We have miles to go before we sleep. The road ahead is exciting with many more challenges, but I firmly believe “We can do it!”

We want to make sure that we are known as a company that is making a huge difference to global healthcare, to cancer care and in addressing many other unmet needs in chronic diseases worldwide.

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