The document discusses recent advances in biosimilars and their future prospects. It begins with an abstract about a student's seminar presentation on personalized medicine and pharmacogenomics. The contents section lists topics like what biosimilars are, literature reviews on the use of targeted drugs and clinical trials, the need for and advantages of personalized medicine, and case studies on using genetic testing to target lung cancer treatments. It explores how pharmacogenomics can optimize drug responses based on a patient's genetics and discusses patents and the future of personalized healthcare.

1. MIT-WPU | School of Pharmacy
WORLD’S FIRST UNIVERSITY
FOR LIFE TRANSFORMATION
Recent advances in Biosimilar and its future
prospects.
Name: Asmita Gupta
Class and Sem: M. Pharm (1st Sem)
ERP No: 1102200006
Email: asmitagupta.34@gmail.com
Guide: Dr. Satish Polshettiwar
3/20/2021 1
2020-2021
Seminar on

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CONTENTS
 ABSTRACT
 INTRODUCTION
 WHAT ARE BIOSIMILARS
 LITERATURE SURVEY
 NEED OF PERSONALIZED MEDICINE
 PHARMACOGENOMICS
 POLYMORPHISM
 ADVANTAGES OF PHARMACOGENOMICS
 LIMITATIONS
 CASE STUDY
 PATENTS
 PERSONALIZED MEDICINE- FUTURE OF HEALTH CARE SYSTEM
 CONCLUSION
 BIBLIOGRAPHY

3. Keywords: Personalized, Pharmacogenomics, Proteonomics
3/20/2021 3
ABSTRACT
Name of Student: Asmita Gupta
Date:18-03-2021
Time: 03:35PM
Name of guide: Dr. Satish Polshettiwar
• Personalized medicine is the combination of genetics and genomics to speculate about a
patient prognosis and diagnosis and thus improving his health. The heed to the personalized
medicine is getting intensified partially due to the development in Human genome project.
Scientists believe that every being in this planet possess nuance and distinctive
characteristics at genetic, behavioral and physiological level and perhaps contribute to
different diseases. There are several recent scientific advancements in technologies such as
DNA sequencing, genomics, proteonomics, imaging protocols. Health monitoring devices,
which has believed us into great inter-individual variation in disease processes. The money
matters and time dissipation can be immensely reduced also the standard of life can be
enhanced with the implementation of Personalized medicine. PM paramount focus is on
preventative medicine and takes bold action rather than just reactive.
TITLE- Recent advances in Biosimilar and its future prospectus

4. • Biosimilar is exactly what its name implies- it is a biologic that Is similar to another biologic
medicine which is already licensed by the US Food and Drug Administration [FDA].
• They are similar in terms of quality, safety and efficacy to an already licensed, well-established
reference medicinal product.
• The term “Personalized medicine” is often used to mean “to give the right patient, the right
dose at the right time.”
• It may be thought of as a treatment appropriate to the patient's symptoms, requirements,
and preferences.
• , treatmentfollow-up.
INTRODUCTION

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WHAT IS BIOSIMILARS?
E.g. Hormones, Vaccines, Mabs etc

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LITERATURE SURVEY
• ALICE T. SHAW et. al [2010] He evaluated the efficacy of ALK-blocking therapy in such
tumors in the first clinical trial of crizotinib an oral inhibitor of ALK tyrosine kinase. The
pressure of ALK on lung tissue has led to tumor reduction or disease stability.
• JAMES L. RILEY et. Al [2016] published an article on the development of HIV-1 resistance to CD4
+ T cells by genetic modification using zinc-finger nucleases in which they discussed the
naturally occurring naturally32 HIV co-receptor CCR5 provides resistance to HIV infection -1. The
genetic disruption of CCR5 provided strong, stable and fear-inspiring protection against HIV-1 in
vitro and in vivo in the NOG model of HIV infection.
• ELIAS SAIS et. al [2017] did research on the QUARTZ trial to understand the role of complete
radiotherapy in the brain {WHRT} in patients with non-small cell lung cancer and brain mastases.
Researchers discuss the results of the QUARTZ trial and their problems in clinical practice and
potential biomarkers that can be used to identify radio-resistant patients.

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LITERATURE SURVEY
• Sonia del Barco et. al [2010] elaborate on the guidelines of the SEOM {Spanish Society of
Medical Oncology} on pharmacologic intervals for breast cancer. Recent advances in the
management of the disease can be in the form of adjuvant neoadjuvant preparation, cytostatic
and hormonal treatment, so that it can easily be helpful to the physiotherapist, citizens and
other related factors.

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ERA OF PHARMAGENOMICS

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NEED OF PERSONALIZED MEDICINE
• The same symptoms but different illnesses
• Medical interventions can work for some people but not for
others
• 40% of the medication taken does not work for patients.
• Genetic development helps to treat the patient more accurately
and effectively
• To avoid any allergic reactions.

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PHARMAGENOMICS
• Study the differences in DNA and RNA characteristics as related to drugs to answer the most
important area of ​​customized medicine.
• Integration of pharmacy and genetic development.
• It pursues to comprehend how genetic variation and expression influence the body’s response
to medicines
• It utilizes genetic information (like DNA , gene, and copy number) to explain the difference
between drugs (pharmacokinetics) and the its's immune response (pharmacodynamics).

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Step1
Step2
Step3
Step4
When medications are
consumed,their
componentsare
metabolizedbyenzymes
Butgeneticdifferences
cancreatesubtle
changesthat alter how
thesepathwayswork.
Forthis reason,a
medication that works
for onepersonmay have
radically different
effectson another.
In theory,thesepathways
would function in the
sameway in all humans,
https://www.slideshare.net/apushi/pharmacogenomics-a-step-to-personalized-medicine
PHARMAGENOMICS TARGET BIOMAKERS

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Itisknownthatdistinctpatientsresponddifferentlytotheidenticalmedicat
Geneticscanaccountfor 20-95 percentof
variability in drug disposition andeffects.
• Mainly due to sequencevariants in genes encoding
drug-metabolizing enzymes, drug transporters, or
drugtargets
GENETIC
•Age
•Gender
•Ethnicity
•BMI
•Co morbidity
•Family history
•Circadian
rhythm
•Placebo
effect
GENOMIC
•Genome
•Transcription
•Proteome
•Metabolome
•Epigenome
•Microbiome
ENVIRONMENTAL
•Nutrition
•Drugs (drug-
drug
interactions)
•Chemical
exposures lifestyles
•Circadian rhythm
•Epigenome
•Compliance
and adherence
https://www.slideshare.net/apushi/pharmacogenomics-a-step-to-personalized-
medicine

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• Optimizing drug response:gene-drug interactions.
• Gene-based drugtargeting
• Prediction and diagnosis
Focusing on genomics, we have
identified three categories:

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POLYMORPHISM
Indels
SNPs
Polymorphism varies in the sequence of DNA that is present
in the frequency of 1% or more in humans.
Two major types of sequence variation are:
Single nucleotide polymorphisms (SNPs)
Insertions/deletions (indels).
• >1%
• SNP variation is present in considerable
population
• <1%
• Indels are much infrequent in the genome
and are of low frequency
14
https://www.slideshare.net/apushi/pharmacogenomic
s-a-step-to-personalized-medicine

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ADVANTAGES OF PHARMACOGENOMICS
• Creating customized medicines.
• Improving rational drug development
• Diagnosis and monitoring of certain diseases
• Predicting patients' response to drugs
• Reduce or eliminate adverse events
• Making the most powerful, safe drugs
• Improving efficiency and patient adherence
• Improving the accuracy of getting the right doses of medication
• To allow for advances in drug research and development (R&D) and the approval of new drugs

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LIMITATIONS
• Scientific challenges (where genetic traits are very important in clinical practice,
by misunderstanding mechanisms of recognized diseases)
• Protection of confidential information during investigation and development
• Health workers: currently there is not enough training on the use of personalized
drugs, not in medical school courses.
• IT health care IT is necessary to link patient information with genomic research.

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CASE STUDY- 1
Target ALK: treated with Xalkori
REFERENCE- Jessica J. Lin,1 Gregory J. Riely,2 and Alice T. Shaw, Target ALK: treated with Xalkori, Cancer
discovery, Vol 7, February 2017, page no: 8-9
ABSTRACT-Anaplastic lymphoma kinase (ALK) is a proven target in many reconstituted ALK patients,
involving non-small cell lung cancer (NSCLC). Various forms of ALK TKIs have been identified, and these
basic techniques inform the physician to develop custom-made drugs such as xalkori.
METHOD-Haney started taking Tarceva in 2008. After three years, the drug was not being absorbed into
the tissues. Driven by friends and other doctors, she underwent a genetic test on his tissue, which showed
that she had ALK (anaplastic lymphoma kinase). She started taking Xalkori (crizotinib), which is specifically
targeted at lung cancer cells with ALK cancer. She joined the Xalkori clinical trial in Philadelphia. After thirty
six months, her tissues were invisible.

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Haney began
taking Tarceva
Diagnosed with
ALK after genetic
testing
Joined clinical trial
for specifically
designed ALK
Patient with Non-
small cell lung
cancer
Started taking
Xalkori
Tumors were
barely visible
In 2008
Three years later
FLOWCHART FOR CASE STUDY- 1
Within 3 years

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CASE STUDY- 1
RESULT - Treatment of lung cancer is one of the most advanced in terms of customized treatment, with
several FDA-approved drugs or biomarker clinical trials for various lung cancers. Unfortunately, but
unexpectedly, Haney found out last October that the cancer had moved to her brain, one of the many lung
cancer areas prone to migration. Because Xalkori will not break the blood-brain barrier, he simply started
another experimental drug, LDK378, to treat a brain tumor.
CONCLUSION - A growing group of researchers, other health professionals, and a growing number of
patients are looking for a customized approach that is as focused on disease prevention as it is on the
practice of treatment when it is available. Call it your choice - a personalized medicine, a genomic
medicine, an accurate medicine. It is a way of emphasizing the ways the risks of your diseases are unique,
as are some of your obvious features.
• https://www.youtube.com/watch?v=tPbiSwok4qs
• http://genomemag.com/what-is-personalized-medicine/#.WY7t7VGg_IU

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CASE STUDY- 2
Patient with HER2-Positive Metastatic Breast Cancer Responded to Ado-Trastuzumab
Emtansine
REFERENCE-Elia Sais and Sonia Del Barco, A Case Report of a Patient with HER2-Positive Metastatic
Breast Cancer on Dialysis, Who Responded to Ado-Trastuzumab Emtansine Annals of clinical case
reports, 20 Nov 2017, Vol-1, Page no. 1-3
ABSTRACT-Ado-trastuzumab emtansine (T-DM1) is a growing human receptor 2 (HER2) drug that
contains trastuzumab, a stable link, and a cytotoxic agent based on maytansine (DM1). When T DM1
binds to the HER2 receptor, it allows the delivery of drugs within the cells especially to HER2-
overexpressing cells, reducing drug exposure in normal tissues.
METHOD-A 47-year-old Caucasus woman underwent mastectomy and removal of the axillary nodes
June2012. She received trastuzumab and docetaxel for breast cancer in December 2012 every Thursday.
She completed six treatment cycles with a complete response to liver and osteoporosis. He continued
receiving trastuzumab until September 13, when a CT scan showed the progression of the disease in the
liver.

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Received
trastuzumab and
docetaxel
CT scan revealed
disease
developement in
the liver.
But new tumors in
the peritoneum
appeared
Caucasian woman
underwent a
mastectomy
Started taking T-
DM1
Revealed complete
response in
peritoneal
Carcinomatosis
In 2012
DECEMBER, 2013
DECEMBER, 2014
FLOWCHART FOR CASE STUDY- 2
SEPTEMBER,2014

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CASE STUDY- 2
On August 2014, CT scans disclosed steady diseases in liver, but new tissue appeared in
peritoneum. She started T-DM1 in September 2014. A CT scan was performed in December
2014 after three months, which disclosed partial bone response.
RESULT - One patient with this disease was treated with T-DM1, but there is no dose
recommendation. We have shown here a case of a 47 year patient with HER2 + MBC in dialysis
treatment with T-DM1 without a trial. T-DM1 receiving patient tolerance was predictable and
received a strong response.
CONCLUSION - Previous experimental studies have exhibited that the pharmacokinetic
properties of T-DM1 are unaffected by lifetime, race or kidney function. Patients with severe
renal impairment do not have specific trials for T-DM1. Only a patient with this disease had
been treated with T-DM1, though dosage regimen were not given

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PATENT
Publication number Priority date Publication date Assignee Title
US5078734A
{US}
1990-10-22 1992-01-07
David E. Noble
Medication dispensing pacifier
EP3600303A4
{EUROPE}
2018-08-15
2020-12-16 Thomas Julius
Borody
Compositions, devices and
methods for treating autism
JP6436580B2
{JAPAN}
2012-06-04
2018-12-12 Gaurabu
Agurawaru
Compositions and methods for
treating Crohn's disease and
related conditions and
infections
US20190314355A1
{US}
2017-10-15
2019-10-17 Centre for
Digestive
Diseases
Compositions and methods for
treating, ameliorating and
preventing h. pylori infections
https://www.uspto.gov/web/patents/classification/cpc/pdf/cpc-definition-A61J.pdf https://patents.google.com/ https://ipindia.gov.in/

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PERSONALISED MEDICINE: FUTURE OF HEALTHCARE
SYSTEM
• The impact of strategies to provide accuracy in drug development.
• The impact of strategies to provide accuracy on health care delivery.
• Improving the evidence base for the adoption of specific drugs.
• National succession plans
• The impact of recent ideas on the development of accurate drugs based on
pharmacogenomics, pharamcogenetics.
• Predicting drug abuse and drug safety.

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CONCLUSION
• As a generic drug is widely used, it will enable manufacturers to develop drugs aimed at
young people who respond to antiretroviral drugs that may have failed to work within
the traditional health system.
• The study of DNA and RNA variability has greatly influenced the development of custom-
made drugs.
• Pharmacogenomics focuses on improved drug responses and gene-based drug
administration.
• Sir William Osler's famous quote: The good physician treats the disease, the great
physician treats the patient who has the disease.

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REFERENCES
1. F.Randy Vogenberg., Carol Isaacson Barash., Michael Pursel, Personalized Medicine Part 1:
Evolution and Development into Theranostics, Vol. 35. {2010}, 10-15, DOI: 10.560
2. Meghna Dutt Paving way for personalized medicine, FDA’s role in new era of medicalproduct
development, October 2013 ,1-15, DOI: 10.1034
3. Astrid M. Vicente, Wolfgang Ballensiefen & Jan-Ingvar Jönsson, How personalised medicine will
transform healthcare by 2030: the ICPerMed vision, Journal of Translational Medicine, 28 April 2020,
Vol. 6, 1-5, DOI: 10.1186
4. Sunil Mathur, Joseph Sutton, Personalized medicine could transform healthcare, Biomedical Reports,
June 2 2017, Vol. 7, 3-4, DOI: 10.3892
5. James. Riley, PD-1 signaling in primary T cells, NIH, Vol. 229, May 2009, 1-19, DOI: 10.1111

27. 27
REFERENCES
6. James L. Riley Carmine Carpenitoa, Michael C. Milonea,b, Raffit Hassanc, Control of large,
established tumor xenografts with genetically retargeted human T cells containing CD28 and
CD137 domains, PNAS, Vol. 106, March 3 2009, 3360-3365 DOI:10.1073
7. Richard G. Carroll,* James L. Riley, Cutting Edge: Regulatory T Cells from Lung Cancer Patients
Directly inhibit Autologous T Cell Proliferation* The Journal of Immunology, Vol. 106,March 2021,
4272- 4278 DOI: 10.4049
8. Alice T. Shaw, Yung-Jue Bang, Anaplastic Lymphoma Kinase Inhibition in Non–Small-Cell Lung
Cancer, The new England Journal of medicine, Vol. 363, October 28, 2010, 18,DOI:10.1056
9. Alice T. Shaw et. al Alectinib versus Crizotinib in Untreated ALK-Positive Non–Small-Cell Lung
Cancer, The new England journal of medicine, Vol. 363 August 31, 2017, 830-838,DOI:10.1056
10. John Lafrate Aaron N. Hata Beow Y. Yeap Alice T. Shaw, Patterns of Metastatic Spread and
Mechanisms of Resistance to Crizotinib in ROS1-Positive Non–Small-Cell Lung Cancer, American
Society of Clinical Oncology, Vol. 1, June 2016, 13-17 DOI:10.1200

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