Overview
Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally. It is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions. It has one of the largest global biosimilars portfolios, spanning recombinant human Insulin (rh-Insulin), insulin analogs, monoclonal antibodies and other recombinant proteins for diabetes, cancer, autoimmune conditions and other life-threatening diseases. The company has multiple commercial-scale manufacturing platforms with capacities to support a global play.
The Company has over the years benefited the lives of millions of patients and built credibility globally as a strong biosimilars player. Its scientific know-how, technological expertise and global scale manufacturing capabilities have positioned it ahead of the curve in the realm of biosimilars. Today, it has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan.
Biocon Biologics has the knowledge, commitment and culture to be the most trusted biosimilars R&D, manufacturing and commercial partner for enabling affordable access to patients worldwide.
OUR PURPOSE
Patients
We aim to touch the lives of millions of Patients by enabling affordable access to one of the largest and most diversified portfolios of biosimilars, including rh-insulin, insulin analogs, monoclonal antibodies, and other recombinant proteins, to treat chronic diseases like diabetes, cancer, and autoimmune diseases.
People
Our strength lies in our People who uphold the core values of integrity, quality, reliability, and innovation. As one of the leading Biosimilars Player, we have built a strong peoples’ organization that is pursuing a mission to make a difference to global health.
Partners
We have built strategic global and regional partnerships of a symbiotic nature that have allowed us to share risks, lower costs, maximize efficiencies, expedite the development and commercialize products in various global markets. Through our strong network of Partners we will continue to expand affordable access to biopharmaceuticals and make an enduring impact on global health.
Business
We have built a robust biosimilars-led Business and aim to ensure sustainable long-term growth by disruptively serving the needs of patients, prescribers, and payers through our portfolio of life-saving biologics that enhance affordability and accessibility of chronic therapies.
PATIENT CENTRICITY
We are working to create a patient ecosystem that offers unique patient experience. We are aiming to offer innovative healthcare solutions.
We aim to serve over ~ 2.6 Million patients in FY20 and aspire to Touch 5 Million patient lives by FY22.
OUR EXPERTISE
Our Manufacturing Facilities
We have globally compliant manufacturing facilities across diverse technology platforms spanning insulin analogs, monoclonal antibodies and other recombinant proteins. We continue to expand our infrastructure in a capital efficient, modular way.
Our Science
In pursuit of our objective of enhancing global healthcare through innovative and affordable biopharmaceuticals, Biocon’s Research and Development (R&D) function has built world-class competence and capability on the back of robust infrastructure and a talent pool that has extensive global product development experience.
R&D’s core strategy is based on integrated discovery, stage gated approach to development, core disease area expertise (autoimmune and inflammation, oncology and diabetes), and a first-rate scientific advisory board.
Our Quality Standards
At Biocon Biologics, excellence through Quality and Compliance is one of our core values and we strive to achieve it consistently across all functions associated with Research & Development, Manufacturing, Testing, Release, and Distribution of our differentiated products.
We follow Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) and Good Documentation Practice (GDP) throughout our operations with no compromise on compliance, which in turn ensures high standards of quality at all times.
A ~1,000-strong, well-trained Quality team works 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. Our Quality Control and Quality Assurance teams ensure compliance with cGMPs to deliver high-quality products consistently.
OUR DIFFERENTIATORS
Ahead of The Curve
Biocon Biologics’ edge comes from nurturing internal scientific talent and R&D infrastructure to support existing programs as well as an expanding pipeline; being in constant dialogue with key stakeholders to drive biosimilar adoption; seeking cost advantages through technology and operational excellence; being ever vigilant on quality and compliance through continuous improvement; and striking strategic partnerships to manage risks and bridge near-term experience gaps.
Robust R&D Capabilities
Biocon Biologics has a strong foundation in robust internal R&D capabilities across the entire development continuum spanning clone generation, process and analytical, pre-clinical and clinical development. Our regulatory strategies have benefited from the experience of navigating an evolving regulatory landscape as agencies gain confidence in delineating abbreviated approval pathways for biosimilars.
Global Scale Manufacturing
The Company has made significant investments in commercial scale, globally compliant manufacturing facilities across diverse technology platforms spanning insulin analogs, monoclonal antibodies and other recombinant proteins. We continue to expand our infrastructure in a capital efficient, modular way.
Sharing Risk-Reward through Partnerships
The Company shares the risk and reward of biosimilars development through partnerships that bring in complementary skills and experience. It has a long standing, successful global partnership with Mylan for a range of biosimilar antibodies and insulin analogs. The Company has also entered into a global partnership with Sandoz (a division of Novartis) to prepare for the next wave of biosimilar opportunities that open up towards the middle of the next decade. We also have strong regional partnerships in many key emerging markets. Partnering with local companies helps us overcome local resource and knowledge gaps, get access to local commercial capabilities, distribution networks and distinctive understanding of local stakeholders including prescribing physicians.
OUR BIOSIMILARS
Insulins & Analogs
Our Pichia pastoris platform for expression of recombinant protein is our proprietary technology, which is applied in the rh-insulin and insulin analog product lines. We were the first company in the world to have successfully commercialized the large-scale manufacture of human insulin, using this proprietary technology. The human insulin facility employs several sophisticated technologies and equipment used for the first time in India.
Monoclonal Antibodies & Other Recombinant Proteins
Biocon Biologics has one of the largest global biosimilars portfolios, spanning monoclonal antibodies and other biologics for diabetes, oncology and immunology. We have built multiple commercial scale manufacturing platforms with capacities to support a global play and have successfully commercialized several of our biosimilars in various markets across the globe. We are developing a high-value portfolio of biosimilar mAbs and recombinant proteins in partnership with Mylan since 2009.
OUR PRODUCT PIPELINE
Currently, Biocon Biologics has a 200,000 sq. ft state of the art Research & Development Centre at Biocon Park, Bengaluru, India. The Company has a product pipeline of 28 molecules, including 11 with Mylan, few with Sandoz and rest on its own.
THERAPY FOCUS: Diabetes, Oncology, Immunology, Dermatology, Ophthalmology, Neurology, Rheumatology and Inflammatory Diseases.
Biocon’s Global Partnership with Mylan
11 Biosimilars are being co-developed for global markets
- Partnership Leverages Biocon’s Strong Development & Manufacturing Capabilities & Mylan’s Regulatory & Commercial Excellence
- Cost and Profit Share Model
| Molecule | KEY MOLECULES STATUS |
| TRASTUZUMAB | Launched in EU, Australia & Emerging Markets. Approved in U.S., Canada |
| PEGFILGRASTIM | Launched in U.S. Approved in EU, Canada & Australia |
| BEVACIZUMAB | Launched in India. Global Phase III |
| INSULIN GLARGINE 100 IU/mL | Launched in EU, Australia, Japan* & Emerging Markets. Approved in New Zealand. Under review in U.S. |
| INSULIN ASPART | Global Phase III |
| RECOMBINANT HUMAN INSULIN | Launched in Emerging Markets. In active development for U.S. (partnered with Lab PiSA) |
Biocon’s Exclusive Partnership with Sandoz
With SANDOZ, set of next-gen immunology, oncology biosimilars are being co-developed for global markets. Various assets are in early stage development stage for global markets.
- Both Partners have Shared Responsibility for Development, Manufacturing, Global Regulatory approvals
- Costs & Profits are Shared Equally
- Broader Biocon Participation in End-to-End Development and Commercialization
