EVOLUTION

OF BIOCON R
AND D

- BY GROUP 6
 INTRODUCTION
• BIOCON IS INDIA’S FIRST AND THE LARGEST PUBLIC LISTED BIOTECH COMPANY

• BIOCON IS A LEADING GLOBAL BI0PPHARMA INTERPRISE HAVING COMMERCIAL

FOOTPRINTS OVER 120 COUNTRIES

• VISION- TO ENHANCE GLOBAL HEALTHCARE THROUGH INNOVATIVE AND AFFORDABLE

BIOPHARMACEUTICALS FOR PATIENTS, PARTNERS AND HEALTHCARE SYSTEM ACROSS
THE GLOBE

• BIOCON IS AMONGST INDIA’S HIGHEST R AND D SPENDER

• AS AN ORGANIZATION BIOCON HAVE INVESTED IN CREATING STATE OF THE ART

LABORATORY AND WORLD CLASS MANUFACTURING CAPABILITIES
HIGH STRONG
HIGH AFFORDABILI
RELIABILI INNOVATIO TY
QUALITY
TY N
 EVOLUTION OF BIOCON R AND D:API
OVERVIEW
• ACTIVE PHARMACEUTICAL INGREDIENT (API) IS THE BIOLOGICALLY ACTIVE COMPONENT OF A DRUG PRODUCT
(TABLET, CAPSULE, CREAM, INJECTABLE) THAT PRODUCES THE INTENDED EFFECTS
• APIS FIND APPLICATION IN HIGH QUALITY DRUGS THAT TREAT DISEASES PERTAINING TO ONCOLOGY,
CARDIOLOGY, CNS AND NEUROLOGY
• APIS CAN POTENTIALLY CREATE A MORE SUSTAINABLE HEALTHCARE SYSTEM BY INTRODUCING MORE
INNOVATIVE PRODUCTS
• BIOCON’S GLOBAL PORTFOLIO IN ACTIVE PHARMACEUTICAL INGREDIENT (API) CATERS TO OVER 1200 PHARMA
COMPANIES IN 100+ COUNTRIES INCLUDING THE U.S, EUROPE AND LARGE EMERGING MARKETS, WITH A TRACK-
RECORD OF EXCELLENCE FOR OVER 20 YEAR.
STRATEGY
• OUR EXPERTISE IN FERMENTATION TECHNOLOGY, LARGE SCALE CHROMATOGRAPHY AND SYNTHETIC
• IN ADDITION, BIOCON OFFERS PELLETS / PREMIXES OF SELECT APIS BASIS CUSTOMER AND MARKET
REQUIREMENTS
• OUR FACILITIES ROUTINELY UNDERGO GLOBAL ACCREDITATIONS AND COMPLIANCE INSPECTIONS
 EVOLUTION OF BIOCON R AND D:API
Biocon R&D has come a long way in its journey of revolutionizing the future from
humble beginning to pioneering breakthrough. Biocon has continuously pushed
boundaries in development of active pharmaceutical ingredient

EMBRACING CUTTING EDGE

THE ADVANCED TECHNOLOGIES
AUTOMATION AND
INNOVATION IN ANALYTICS
API METHODOLOG
Y
 GROWTH OPPORTUNITIES
The future outlook for Biocon R&D API is promising as the company continues to invest in
research and development, expand strategic partnerships, and collaborate with industry leaders.
This will create opportunities for growth and innovation, enabling Biocon R&D API to develop
groundbreaking treatments and contribute to advancements in the field of drug discovery.
 F O R M U L AT I O N S
OVERVIEW
• AT BIOCON, PATIENTS ARE OUR PRIORITY
• BY DEVELOPING A ROBUST PIPELINE OF DIFFERENTIATED GENERIC FINISHED DOSAGES FOR GLOBAL
MARKETS, WE FULFIL THEIR DEMAND FOR QUALITY AND AFFORDABLE HEALTHCARE
• THE STRENGTH OF GENERIC FORMULATIONS BUSINESS IS POWERED BY THEIR PORTFOLIO OF COMPLEX AND
DIFFERENTIATED API
GENERIC FORMULATIONS
• THE DOSAGE FORMS IN PORTFOLIO INCLUDE
• ORAL SOLIDS (POTENT AND NON-POTENT)
INJECTABLE
DEVICE DEPENDENT FORMULATIONS
• PRODUCTS IN ONCOLOGY, CARDIOVASCULAR DRUGS: STATINS, DIABETES, TRANSPLANTS AND MULTIPLE
SCLEROSIS
 F O R M U L AT I O N S
• The pipeline comprises oral solids and parenteral formulations in both the potent and non-
potent compounds categories, in the core therapeutic areas of metabolics, cardiovascular,
oncology and immunotherapy.
• Products include Tacrolimus & Atorvastatin & Labetalol(commercialized in US)

• Expertise on the high potency and injectable drug product manufacturing.

• Efficient and reliable supply chain unfailingly delivers their formulations across continents
as per the committed schedules.
• A strong track record on international quality compliance
 SERVICES

• Syngene is a publicly listed subsidiary of Biocon Ltd.

1. Established Leader: India's pioneering Contract Research Development and Manufacturing Organization
(CRDMO) since the early 1990s.
2. Comprehensive Solutions: Seamlessly offering customized services for discovery, development, and
manufacturing of novel molecules.
3. End-to-End Approach: Integrated R&D disciplines, ensuring quality project delivery on time, every time.
4. Safety and Quality: Clear commitment to safety and operational excellence, maintaining high-quality
standards.
5. Collaborative Ecosystem: Moving beyond outsourcing, forging true end-to-end collaborations with clients.
6. Scientific Expertise: Adept problem-solving and innovation-driven by a team of experienced professionals.
7. Compliance Focus: Proven track record of adhering to regulatory and quality compliance standards.
Syngene’s business is divided into four divisions – Discovery Services, Development Services, Manufacturing Services and
Dedicated R&D Centres.

A. Discovery Services:
• Early-stage research from target identification to drug candidate delivery.
• Facilitating further development of potential drugs.
• B. Development Services:
• Encompassing pre-clinical to clinical trials activities.
• Drug substance and drug product development to demonstrate safety and efficacy.
• C. Manufacturing Services:
• Manufacturing of small and large molecules.
• cGMP compliant facilities for clinical supplies and commercial volumes.
• D. Dedicated R&D Centres:
• Tailored support for client-specific R&D requirements.
• Dedicated multi-disciplinary scientific teams and ring-fenced infrastructure.
 EVOLUTION OF R N D OF BIOCON (BIOSIMILAR)

• Biocon was founded in 1978 with Rs.10,000 as the initial capital by a Kiran Mazumdar(CMD) , based in
Bangalore.
• Biocon biologics’ research and development organization develops high-quality biosimilars (recombinant
insulins, monoclonal antibodies and other protein therapeutics).
• High-quality and affordable biosimilars.
• First Indian company to manufacture and export enzymes to USA and Europe in 1979.
• 7th leading Bio-pharmaceutical Company in the world.
• Unilever acquired Biocon Biochemicals Ltd. in Ireland in 1998.
• Dr. Narendra Chirmule (SVP & Head of RnD).
• Started with small enzyme manufacurer to complex generics (statins) and then to more complex biosimilars.
• Biocon’s key products- INSUGEN® and GCSF in advanced markets like the US and EU.

• Key-Cross subsidizing policy for its revenue stream to fund the growth trajectory and RnD investment. Its De-
risking business and mixed portfolio strategy made exponential long term growth in business.
• Product portfolio - small molecules (generics), novel biopharmaceuticals and biosimilars. Service portfolio
(Research services and clinical research)- managed by biocon subsidiaries- Syngene and Clinigene.
• Biocon followed collaboration and strategic partnership models with global companies to share the risk of
biosimilar development.
• It had a long standing partnership with global generic player Mylan for its postposition of First generation
biosimilars in both insulin & Monoclonal antibody segments which leveraged complementary Compatibilities to
both.
• Therapeutic areas covered- Diabetes,oncology, autoimmune /inflammatory diseases

• Typical biosimilar project stages – Proposal, early Age development ,pre-production planning, late stage
development , production and regulatory submission.
 NEW ERA OF BIOCON
• THE R AND D MANAGEMENT LED BY DR.CHIRMULE PROPOSED A THREE-PHASED APPROACH TO SUPPORT
SHORT TERM BUSINESS PRIORITIES AND TO INSTALL AN EFFECTIVE OPERATING MODEL ‘THE NEW WAY OF
WORKING AT BRC.’

PHASE 1- PHASE 2- PHASE 3-INSTALL

ESTABLISH VISUALIZE THE NEW OPERATING
COMMON NEW ERA OF R AND MODELS: CREATE A
UNDERSTANDING D: ENGAGE CROSS PRAGMATIC,
OF FUNCTIONAL MULTI YEAR PLAN
PRIORITIES,DELIVE LEADERS AND TO EXECUTE THE
RABLES,MARKET INTERNAL AND STRATEGY.
ENTRY TIMELINE EXTERNAL
FOR BIOSIMILARS VISIONARIES
AND INSULINE CRAFT WELL
BUSINESS ALLIGNED, CLEAR
VERTICLES.ADDRE VIEW OF LONG
SS SHORT TERM TERM VISION,
BUSINESS NEEDS. AMBITION AND
STRATEGY FOR R
AND D.
THANK YOU