Biocon is Asia's premier biopharmaceutical company that is driven by the vision to make a difference to global healthcare through improved access to high quality, life-saving biotherapeutics by making them affordable for patients across the world.
We have evolved from manufacturing pharmaceuticals like statins and immunosuppresants, to discovering, developing and producing biologics in chronic therapies such as diabetes, oncology and immunology for global markets. This has translated into a diversified and differentiated pipeline of fermentation-derived complex generics, biosimilars that include insulins and monoclonal antibodies, and novel biologics.
Biocon was among the early movers in industry to pursue a high risk strategy of developing biosimilars for global markets. Through our ‘Made in India’ biosimilars business, we seek to pursue a humanitarian path that will provide affordable access to high quality generic biologics to make a difference to diabetes, cancer and autoimmune diseases. We have succeeded in bringing the benefit of high quality biosimilars to patients in India, other emerging market countries in Latin America, Africa, Middle East & Turkey, Asia-Pacific regions and also now in developed markets of U.S., EU and Japan.
A combination of specialized talent, state-of-the-art research and manufacturing infrastructure and a culture of deep science and regulatory compliance have differentiated us in the marketplace and given us a distinct competitive edge. It has also led to Biocon being recognized as a credible global biopharmaceuticals player.
Biocon has created large-scale fermentation capabilities to support manufacturing of APIs like statins and immunosuppressants. We also built one of India’s largest bio-manufacturing facilities for insulins, monoclonal antibodies and devices. We continue to invest in expanding our manufacturing capacities to address the growing market need.
Biocon’s insulin manufacturing and R&D facility set up in Malaysia with an investment of USD 300 million is the largest integrated insulins facility in Asia. This is the largest foreign investment in biotechnology in Malaysia and reﬂects our commitment to serve patients in different parts of the world.
We have created a highly cross-functional matrix focused on products, processes and people to reliably and consistently develop and deliver differentiated products. We have consistently been among the pharma companies in India with the highest investments in research and development. We have leveraged India’s value advantage of unmatched scientific talent and cost-competitive manufacturing to deliver scale, speed and quality. Over time, we have emerged as a highly innovative biopharmaceuticals enterprise that has benefited millions of patients in over 120 countries.
Commitment to Quality
Biocon’s state-of-the-art manufacturing facilities are qualiﬁed by various regulatory agencies from developed and emerging markets. With an unwavering commitment to quality assurance and stringent quality controls, Biocon is on a mission to go beyond compliance and achieve global standards of excellence.
A well-trained Quality team works round the clock to monitor every step of the development and manufacturing process to ensure that each and every product manufactured and distributed by us complies with all internationally accepted good practices and standards of quality, purity, efficacy and safety.
Biocon’s business is organized into the following reporting segments:
a) Small Molecules API & Generic Formulations
b) Biologics - Biosimilars (Insulins, MAbs & other Biologics) & Novel Biologics
c) Branded Formulations (currently India & UAE)
d) Research Services (Syngene)
Small Molecules: APIs and Generic Formulations
Biocon has focused on its core biotech capabilities in selecting its differentiated API portfolio largely comprising fermentation-derived molecules such as statins, orlistat, immunosuppresants, and other speciality molecules. These are sold to third party customers who in turn formulate and sell the finished dosages in global markets including the U.S., Europe and large emerging markets.
Since the late 1990s, we have emerged as a preferred APIs partner for over 1,000 pharma companies in more than 100 countries and have long-term business relationships with many of them.
We now want to leverage and expand upon the reliability we have built over the years to emerge as a key player with our Generic Formulations aimed at niche therapy areas. Potential customers who wish to secure their supply chain from a continuity of supply perspective appreciate our vertical integration across APIs and formulations and consistent track record in quality compliance.
Biologics (Biosimilars & Novel Biologics)
As one of the earliest players in the realm of biologics in India, Biocon has created a rich pipeline of novel and biosimilar assets aimed at addressing local as well as global unmet medical needs associated with non-communicable diseases.
Status of Biocon’s Global Biosimilars Portfolio
Biocon has one of the largest global biosimilars portfolios, spanning recombinant human Insulin (rh-Insulin), insulin analogs, monoclonal antibodies and other biologics for diabetes, oncology and immunology. We have successfully commercialized several of our biosimilars in various markets across the globe.
We have partnered our biosimilar portfolio with global generic majors, Mylan and Sandoz, to develop a portfolio for global markets. At the same time, we continue to work independent of these partnerships towards augmenting our portfolio with more biosimilar candidates under development.
We have strong internal R&D capabilities across the entire development continuum spanning clone generation, process and analytical, pre-clinical and clinical development. We also have expertise across the value chain from drug development, CMC to large-scale manufacturing and commercialization.
To maintain our leading edge in biosimilars, we have nurtured highly skilled scientific talent and robust R&D infrastructure; been in constant dialogue with key stakeholders to drive biosimilar adoption; sought cost advantages through technology and operational excellence; been ever vigilant on quality and compliance through continuous improvement; and struck strategic partnerships to manage risks and bridge near-term experience gaps.
Lead Novel R&D Assets
Apart from biosimilars, our biologics strategy has had a keen focus on developing a pipeline of innovative drugs. Our existing novels portfolio has diverse assets acquired through early stage partnerships. These include monoclonal antibodies against novel targets like CD6, against established targets like CD20 and EGFR, and a pipeline of bispecific fusion antibodies that exploit the recent understanding of the role of checkpoint inhibitors. We are working to clinically validate an orally delivered insulin analog, Insulin Tregopil, which is among the most advanced programs in the global oral insulin space and has the potential to transform diabetes management.
We are the pioneers in developing, manufacturing and launching a couple of novel biologics in India, including antibodies like BIOMAb-EGFR®, India’s first indigenously produced novel monoclonal antibody for the treatment of head and neck cancer. We also launched ALZUMAb™, the world’s first novel anti-CD6 monoclonal antibody, in India, for psoriasis. Biocon is the first global company to biologically and clinically validate CD6 as a target for autoimmune diseases.
Biocon's Branded Formulations business focuses on regional markets and is currently operational in India and the UAE. This business has focused on specialty brands in critical therapies and enabled Biocon to emerge as a biologics-led healthcare company offering affordable and differentiated medicines of world-class quality to thousands of patients in India and UAE.
Our Branded Formulations India business has enabled us to carve out a premium niche for ourselves as a biologics-led, specialty products company focused on chronic therapy areas. We are the largest Indian insulins company and one of the leading oncology companies in the country. Some of our key brands are INSUGEN® (rh-insulin), BASALOG® (Glargine), CANMAb™ (Trastuzumab), BIOMAb-EGFR™ (Nimotuzumab), KRABEVA® (Bevacizumab) and ALZUMAb™ (Itolizumab).
Beyond therapy, we support select products with patient friendly initiatives in disease awareness, prevention and management. We also assist healthcare professionals and patients with the treatment of complex medical conditions. This, along with our portfolio approach focused on chronic disease segments, has enabled us to build considerable brand equity for our differentiated products in chronic therapy areas like diabetes, cancer, nephrology, immunology and other life threatening conditions.
Our listed subsidiary, Syngene International Limited, is India’s largest Contract Research Organization (CRO). Syngene started as India’s first CRO and has over the years built a reputation as an end-to-end drug discovery and development services provider for novel molecular entities to the global life sciences sector. It provides integrated discovery, development and manufacturing services for novel molecules across multiple platforms including small molecules, large molecules, Antibody-Drug Conjugates and Oligonucleotides. Syngene brings together a state-of-the-art infrastructure spread across 1.4 mn sq ft and a pool of over 4,000 scientists, to help R&D focused organizations achieve better R&D efficiency and reduce development time.
Reputed Biotech Employer
We have built an employee-friendly environment for our gender-diverse workforce that is comparable to the best in the world. The Science Careers Top 20 Pharma & Biotech Employers Survey 2018 rankings placed us at No.7. We have held on to our position amongst the Top 20 global employers since 2012, the only company from Asia to feature in this prestigious list consistently.
Conscientious Corporate Citizen
At Biocon, Corporate Social Responsibility (CSR) is not about philanthropy, but about creating an ecosystem to empower the stakeholders. We believe that access to good education, healthcare services and civic infrastructure form the three pillars of an empowering ecosystem. We work to address the gender disparity gap in education, healthcare and employment. We have also launched several initiatives to preserve India’s rich heritage in art & culture.
Our comprehensive CSR policy guides the CSR Committee in overseeing and monitoring the CSR initiatives at Biocon. This Board level Committee ensures that these initiatives follow the course of the larger social vision of the company.
Driven by the principle of making an enduring impact, Biocon Foundation partners the society to promote social and economic inclusion. Biocon has been making significant investments over more than a decade in enhancing access to quality healthcare, education and improved civic infrastructure through the Foundation. Combined with field initiatives, the Foundation’s programs have created the momentum to lift up the marginalized sections of the society. In doing so, it has built a strong reputation for the quality of its programs, mostly implemented by partnering government agencies and like-minded organizations.
To create a globally competitive biotech ecosystem in India and make the country’s youth employable, we have set up the Biocon Academy, an advanced centre of biosciences learning. Biocon Academy leverages the rich industry experience of Biocon and subject matter expertise of its education partners to deliver industry-oriented training programs to biotech students. The programs offered by the Academy aim offer advanced learning and industrial proficiency through job-skills development essential to build a promising career in the biotech industry.