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 is among the few companies globally to have received approvals for its biosimilars from developed countries like the U.S., EU, Australia and Japan. Our credibility as a serious player in the biosimilars sector was first established with the Japanese approval for Insulin Glargine. The credibility was enhanced when Biocon, along with partner Mylan, became the first globally to get biosimilar Trastuzumab and Pegfilgrastim approved in the U.S. in 2017 and 2018, respectively. We were also among the first few to receive Insulin Glargine approval in Europe and Australia for Insulin Glargine, both in partnership with Mylan. We have also established our presence in key emerging markets through safe, effective and high quality biosimilars including recombinant human insulin.
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.
To fulfil our mission of making a difference to global healthcare we have made sizable capital intensive investments in research and manufacturing infrastructure to deliver economies of scale. Over the last decade, Biocon has built India’s largest bio-manufacturing facilities in Bengaluru and Asia’s largest insulins manufacturing complex in Malaysia. We have also invested in creating one of the largest fermentation based bulk drug capacities for Statins and Immunosuppressants globally. These investments have and will enable us to have a significant global footprint to serve patient needs.
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
We have established robust regulatory and quality systems to develop and deliver complex therapeutics. Our state-of-the-art manufacturing facilities are designed to conform to the most stringent cGMP guidelines, comply with international regulatory standards and meet client requirements worldwide. We are ever vigilant on quality and compliance through continuous improvement and regularly evaluate our quality systems and manufacturing operations in order to be on par with global best practices.
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. Over the years, we have emerged as the world’s largest statins manufacturer, with our drug substance being used to produce ‘one in every three’ statin pills globally, as well as, a leading player in complex immunosuppressants.
Over the past few years, we have been investing in diversifying this business by getting into generic finished dosages. We have leveraged our strengths in fermentation technology and product characterization to become a vertically integrated player in the niche space of difficult-to-make generic formulations. As part of our Generic Formulations foray, we have launched Rosuvastatin Calcium formulation in the U.S. and select European markets.
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. We have made sizable capital investments in building India’s largest bio-manufacturing facilities in Bengaluru and Asia’s largest Insulins manufacturing complex in Malaysia.
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 is also the first biopharma organization in India to have forayed into the exciting space of (small interfering RNA) siRNA-based therapeutics.
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 1.3 mn sq ft and a pool of over 3,500 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 2017 rankings placed us at No.9. 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.