Group 1.2 - Biocon LTD
Group 1.2 - Biocon LTD
Group 1.2 - Biocon LTD
BIOCON LTD
Submitted By –
Sumedh Malkunaik(22)
Tanuj Barai (24)
Tejas Sukale (25)
Vishal Chaudhari (26)
Contents
Company overview................................................................................................................................2
Business units....................................................................................................................................3
Generics.........................................................................................................................................4
Novel biologics..............................................................................................................................4
Biosimilars (Biocon Biologics Limited)........................................................................................4
Research services (Under Syngene International Limited)............................................................4
Business Unit Revenue 2021.................................................................................................................5
What is Agile Manufacturing?...........................................................................................................5
Why is Agile Manufacturing effective?.............................................................................................5
4 Key Agile manufacturing elements.................................................................................................6
Lean Vs Agile Manufacturing...........................................................................................................6
Is Agile manufacturing for me?.........................................................................................................7
Agile Manufacturing Example...........................................................................................................7
ADDITIVE MANUFACTURING........................................................................................................7
What is Additive manufacturing?......................................................................................................7
How Does Additive Manufacturing Work?.......................................................................................7
Additive Manufacturing Processes....................................................................................................7
Additive Manufacturing Technologies..............................................................................................9
What are the Advantages of using Additive Manufacturing?............................................................9
How Long Does the Process Take?.................................................................................................10
What Materials can be used in Additive Manufacturing?................................................................10
Where is AM used?.........................................................................................................................11
Miscellaneous......................................................................................................................................11
Conclusion...........................................................................................................................................13
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Company overview
Biocon Limited, publicly listed in 2004, is India's largest and fully integrated, innovation-led
biopharmaceutical company. It is an emerging global biopharmaceutical enterprise serving
customers in over 120 countries. Driven by a vision to enhance global healthcare through
innovative and affordable biopharmaceuticals, it have enabled access to advanced therapies
for diseases that are chronic, where medical needs are largely unmet and treatment costs are
high.
The significant brand equity that it has built worldwide for its small molecule APIs across
statins, immunosuppresants and other specialty products has made it a leading global supplier
of these products.
It have also built one of the largest and most diverse biosimilar pipelines, spanning insulins,
monoclonal antibodies and other recombinant proteins that address critical chronic diseases
such as diabetes, cancer and autoimmune disorders.
Ranked among the Top 3 biosimilar players globally for rh-insulin and insulin glargine in
volume terms, Biocon is the first Indian company to launch a biosimilar in Japan with Insulin
Glargine, which also has been approved for sale in EU and Australia. Its insulin products
have made a difference to the lives of millions of people with diabetes across the globe. It
now aims to provide its insulin products to ‘one in five’ people with diabetes in need of
insulin-based therapy anywhere in the world within the next 10 years.
It is also making a huge impact in the area of cancer care. Its biosimilar Trastuzumab, which
was the first to be approved anywhere in the world and launched in India in 2014, has helped
treat several thousand HER2-positive metastatic breast cancer patients. They are also the first
company from India to get its biosimilar approved by the USFDA; Ogivri, co-developed by
Biocon and Mylan, is the first biosimilar Trastuzumab to be approved in the US. In addition
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to Trastuzumab, several of its biosimilar assets are on track for anticipated regulatory
approvals in developed markets.
They are also developing a pipeline of patented biologics to address global unmet medical
needs. It has successfully launched a couple of novel biologics in India: Nimotuzumab for the
treatment of head and neck cancer and Itolizumab to tackle psoriasis. Besides these, they
have a basket of novel assets are under various stages of clinical development, including a
high potential oral insulin.
Through its subsidiary, Syngene, it offers a suite of integrated, end-to-end discovery and
development services for novel molecular entities (NMEs) to the global life sciences sector.
Ranked by the prestigious Science magazine among the Top 10 Best employers in the biotech
industry, Biocon is passionately pursuing a mission to rationalize healthcare spends, enhance
access to life-saving therapies and make a significant impact to global healthcare through
‘blockbuster’ drugs with the potential to benefit a billion patients.
Business units
At Biocon, its strategy revolves around four pillars: accessibility, affordability, availability,
and assurance. It aims to use its expertise and scale to address the underserved or the
unserved markets by enhancing access to essential drugs. With an increased focus on generics
and biosimilars, it continuously innovates to offer affordable medicines and quality
alternatives to expensive drugs to patients globally. Its continuous focus on building strategic
partnerships and simultaneously creating a diverse portfolio of drugs help us increase
medicine availability to a great extent.
Furthermore, it exhibits the highest standards of ethics and are committed to providing high-
quality products in compliance with international regulatory standards. As a global
innovation-led company, its strength lies in its technical & scientific expertise, vertical
integration, a skilled team, quality culture, and a vast network of global partners and
customers.
a. Generics
b. Novel biologics
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c. Biosimilars (Under Biocon Biologics Limited)
Generics
The Generics business has been a key pillar of success for Biocon. Over the past couple of
years, it has sharpened its focus on the generics segment and identified strategic priorities,
which will enable it to realize significant growth opportunities globally. Its strategy is to
continue building a differentiated Active Pharmaceutical Ingredients (APIs) portfolio and
vertically integrate it where possible to manufacture and supply generic formulations for the
global markets. It also continues to explore asset acquisition, external development, and
select in-licensing opportunities to bolster our formulation portfolio.
Novel biologics
The Novel Biologics business of Biocon is a combination of in-house, partnered, and in-
licensed products, targeting therapeutic areas such as diabetes, immunology inflammation,
and oncology, including immuno-oncology.
Biocon operates its biosimilar business through a subsidiary, Biocon Biologics Limited
(Biocon Biologics). It is engaged in developing high quality, affordable biosimilars that can
expand access to cutting-edge therapeutics for patients globally. The R&D, manufacturing,
commercial, and essential business functions for Biocon’s biosimilars business are housed
under Biocon Biologics. Besides, the Branded Formulation India (BFI) business is also a part
of Biocon Biologics.
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The scientific services are accessed mainly by the global pharmaceutical and biotechnology
industry. Nutrition, consumer goods, animal health, and specialty chemicals are among the
other sectors being served by the Company. During the past year, the Company engaged with
over 360 clients from multiple industry verticals.
Business Segments
3%
30% Generics
30%
Biosimilars
Research Services
Novel Biologics
37%
Regional Distribution
19%
Domestic
International
81%
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Financial Data
Companies do not have their vision or mission statement in money terms. Third, many
believe that “intangible assets” such as customer loyalty and patents play a bigger role
in the success of a company than the tangible assets. It often gets difficult to quantify the
intangible assets in monetary terms. Thus, a company can use non-financial measures
to get quantitative and qualitative data on intangible assets. Financial indicators do not give
the full picture. For instance, they do not tell why the sales are dropping, or why the cash
flow is reducing. To get answers to such questions, management turns to non-financial
measures.
The Balanced scorecard is an integrated approach to assesses performance of business strategy and
how changes can be made in the areas such as – financial objectives and goals, customer
preferences and choice architecture, operations management and supply chain bottleneck
resolutions, and organizations learning ability and capacity building Balanced Scorecard is a
resource focused strategic analysis tool. Leaders at Colgate Palmolive can use Balanced Scorecard
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strategic tool to build sustainable competitive advantage by better understanding the relationship
among - financial resources, internal processes, customer preferences, and operations management
The Balance Scorecard of each company varies based on the nature, size of the firm and industry
it operates in. Broadly there are four main components / features of Balance Scorecard. These four
• Financial Perspective
• Customer Perspective
Financial Customer
Innovation Internal
The Syngene team did a great job in
& business
completing all projects on schedule helping it
business Quality control - SQC
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Competition in the Industry
Technological innovation becomes the major separating component. It is likewise helpful for helping
you to customize your method to fit your competitive environment, and to increase your possible
earnings. The trick to establishing a competitive technique is to recognize the sources of the
competitive forces. If the present market growth is sluggish and the industry is filled, product
advancement strategy ought to be used. As quickly as your analysis is ended up, it's time to carry out
a strategy to broaden your competitive advantage. Worth Chain analysis will help the company
pursue a competitive benefits.
Customers have power whenever there aren't a variety of them, but lots of sellers, in addition to
when it is easy to switch from 1 business's services or products to another. They are most likely to
keep using your services if they get rewards. They remain in a far much better position to bargain
than ever in the past. Purchaser PowerLow Customers have actually limited power over console
developers, because the range of potential customers is substantial, the firm isn't too concerned
about losing clients. An increasing market and the capability for high earnings induces new
companies to go into a marketplace and incumbent companies to improve production. Don't forget
that 5 forces affect numerous industries differently and therefore do not utilize specifically the very
same results of analysis for even comparable industries!
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2.4. Implications of industry rivalry
The higher competitive rivalry has therefore led to an overall growth of the industry,
and fuelled development as well internally
Biocon Ltd Building a Biotech Powerhouse focuses on technological advancements
and brand management and brand development as key aspects for building
sustainable competitive advantage and experiencing growth.
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3.5. Switching costs
The issue is however complicated by the high number of players in the industry
offering similar products or services, which reduces switching costs for consumers
Switching costs however may also vary according to the needs and wants of the
consumers, and the types and variants of the products that they prefer
The price competitiveness is especially an important factor for determining the
switching costs for the consumers, in addition to product quality
Industry players focus on brand development and marketing communications to
appeal to consumers, and generate trials.
As a result, the overall bargaining power in the industry is considered to be moderate
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4.4. Substitutes
Players like Biocon Ltd Building a Biotech Powerhouse in the industry are dependent
on manufacturing for producing and marketing their offerings and products
With a manufacturing focused company, the suppliers maintain a higher power
Businesses do not have substitutes and must contract with suppliers for ensuring
quality production and sale of their products
Lower number of substitutes makes switching costs higher, and also increases the
supplier bargaining power
The threat of new entrants for Biocon Ltd Building a Biotech Powerhouse
stands as:
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The technological advancements require high expertise and capital investments
This may not be afforded by new entrants which lowers their threat of entry into the
industry
Threat of substitutes
6.3. Availability
Substitute products for Biocon Ltd Building a Biotech Powerhouse are not easily
available in the market
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The substitute products are made available only at select outlets, through select
channels – given their low demand, and exclusivity
The substitute products are made available only at select outlets, through select
channels – given their low demand, and exclusivity
6.4. Accessibility
Substitute product are not easily accessible
They are produced offshore, and internally distributed and managed by the company
As such, no mass marketing tools are used
Consumers cannot easily locate their stocking
As a result, they are not widely accessible
This lowers the threat of substitutes for Biocon Ltd Building a Biotech Powerhouse
Strategies
Despite a national lockdown, Biocon Biologics was able to sustain operations at all our plants to
meet committed supplies to partners and ensure patients were unaffected. During the nationwide
lockdown in India, we faced many challenges and had to adopt innovative planning and
implementation strategies to run our manufacturing facilities without compromising on the safety
and wellbeing of our employees. We progressed well on new projects to expand our mAbs
manufacturing capacities to address projected volume growth from increased market shares and to
support the development of our biosimilars pipeline. We also augmented our existing Drug
Substance and Drug Product capabilities, which enabled us to expand our capacities multi-fold. We
also tied up additional capacity to meet demand for our insulin and insulin analogs. The
Manufacturing teams successfully managed to scale up production of Itolizumab through effective
planning and execution to ensure timely supplies of ALZUMAb-L for treating COVID-19 patients. In
FY21, Biocon Biologics for the first time completed the tech transfer and scale up of a high cell
density process using alternating tangential flow (ATF) technology.
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at Malaysia, we are providing affordable access to life-saving insulins to patients in developed
markets as well as many emerging markets, including Malaysia. Through our biosimilar insulin analog
portfolio we have enabled the local healthcare system to save over 50% of its spending on diabetes
in Malaysia. The Ministry of Health, Malaysia is deploying these savings to expand insulin access to a
larger patient population. Over time, we expect to enable substantial savings for people with
diabetes across the globe.
Performance measure
Performance management and performance measurement are two key processes that cannot be
separated from one another, as they both proceed and follow each other.
It deals with the evaluation of results, while performance management deals with acting based on
the results of the evaluation and ensuring the target results are achieved.
Performance measures quantitatively tell us something important about our products, services and
the processes that produce them. They are a tool to help us understand, manage, and improve the
Performance management
Performance management is a ubiquitous term in today’s business environment, being embedded
in the body of knowledge of various disciplines and being used at all organizational levels. It
reflects the approach one entity has towards performance and it includes sub processes such as:
strategy definition (planning / goal setting), strategy implementation, initiatives design and
performance measurement.
Performance management is a strategic and integrated process that delivers sustained success to
organizations by improving the performance of the people who work in them and by developing
While performance measurement is a sub process dealing with tracking and evaluation,
performance management creates the larger context to plan, organize, coordinate, communicate
and control performance. It applies at three distinct levels: strategic, operational, and individual
performance management.
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inventory check, to ensure that all departments are using a defined system of recording
transactions. It is done to ensure that the financial statements presented by the organisation are
accurate.
Internal auditing can be done by employees or department heads, and external auditing can be done
by a firm or an independent auditor. The goal is for an independent body to audit and verify the
accounts to ensure that the books of accounts are completed fairly, and that no misrepresentation
The basic principles of auditing are confidentiality, integrity, objectivity, independence, skills and
primary goal of any audit. Before beginning the audit of the final statements of accounts, the
auditor must first comprehend the system and its functionality. It will serve as the foundation for
system. The auditor can rely on the system if the company's internal controls are in place and very
If the internal controls, on the other hand, are ineffective, the auditor must go over the accounts
with a fine-tooth comb. The auditor must also assess the internal control system, according to
CARO 2003.
3)Arithmetic Precision
The auditor must also check the accuracy of the books of accounts regularly. This includes double-
checking the books' arithmetical accuracy and verifying that the entries are properly posted.
4) Principles of Accounting
The auditor must check that the capital and income transactions are properly distinguished. All
financial transactions must fall into one of two categories: revenue or capital. The auditor must
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5) Assets Verification
All the company's assets must be physically verified by the auditor. As a result, he must examine
all legal documents, certifications, official statements, and other documents to determine the
ownership of all assets. The auditor must also make certain that no assets are missing from the
balance sheet.
6) Liabilities Verification
The auditor must also verify the organization's liabilities. He will go over all the documents, letters,
and certificates once again. He can also seek confirmation from outside parties if necessary.
7) Attestation
A paper trail is left behind by every financial transaction. These supporting documentation must
be examined by the auditor to ensure that the transactions are valid and accurate. Vouching is the
term for this. The organisation, for example, has a 12,000/- electrical expense. The auditor must
8) Statutory Obligations
The auditor's job is to ensure that the company's financial records conform with all laws, rules, and
regulations in effect now. As a result, he must ensure that the accounts are compliant with the
Companies Act 2003, the Income Tax Act 1961, and other relevant laws.
shareholders confidence that the accounts are true and fair. It can also help to improve a company's
internal controls and systems. Companies produce financial statements that provide information
about their financial position and performance. This information is used by a wide range of
stakeholders (e.g., investors) in making economic decisions. Typically, those that own a company,
the shareholders, are not those that manage it. Therefore, the owners of these companies (as well
as other stakeholders, such as banks, suppliers, and customers) take comfort from independent
assurance that the financial statements present, in all material respects, the company’s financial
position and performance. To enhance the degree of confidence in the financial statements, a
qualified external party (an auditor) is engaged to examine the financial statements, including
related disclosures produced by management, to give their professional opinion on whether they
fairly reflect, in all material respects, the company’s financial performance over a given period(s)
(an income statement) and financial position as of a particular date(s) (a balance sheet) in
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Elements of financial audit
1. Planning—Initial planning activities include formal acceptance of the client by the audit firm,
verifying compliance with independence requirements, building the audit team, and performing
other procedures to determine the nature, timing, and extent of procedures to be performed to
2. Risk assessment—Auditors use their knowledge of the business, the industry, and the
environment
in which the company operates to identify and assess the risks that could lead to a material
misstatement in the financial statements. Those risks often involve a high degree of judgement and
require a significant level of knowledge and experience by the auditor, particularly on large and
complex engagements. This requires a good understanding of the business and its risks, which is
typically built up over a number of years as part of the audit firm’s and auditor's knowledge. It also
means that the auditors need to be well informed about the industry and wider environment in
which the company operates, and about what its competitors, customers, suppliers and—where
3. Audit strategy and plan—Once the risks have been assessed, auditors develop an overall audit
strategy and a detailed audit plan to address the risks of material misstatement in the financial
statements. Among other things, this includes designing a testing approach to various financial
statement items, deciding whether and how much to rely on the company’s internal controls,
developing a detailed timetable, and allocating tasks to the audit team members. The audit strategy
and plan are continually reassessed throughout the audit and adjusted to respond to new
4. Gathering evidence—Auditors apply professional skepticism and judgement when gathering and
evaluating evidence through a combination of testing the company’s internal controls, tracing the
amounts and disclosures included in the financial statements to the company’s supporting books
and records, and obtaining external third-party documentation. This includes testing
management’s material representations and the assumptions they used in preparing their financial
statements. Independent confirmation may be sought for certain material balances such as cash
5. Finalization—Finally, the auditors exercise professional judgement and form their overall
conclusion,
based on the tests they have carried out, the evidence they have obtained and the other work they
have done.
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This conclusion forms the basis of the audit opinion.
Reference –
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