A Report on Pipeline of Biosimilars in India 2015

FYD Management ConsultantsFYD Management Consultants

Pipeline of

Biosimilars in India

FYD Management Consultants

Objective of the Report

Pipeline report which would help to understand how the competitive landscape would looks like over

next three to five years as there are various molecules which are approaching patent expiry and few of

them have already expired. Many Global and Indian companies are aggressively working towards it to

make their presence in this category

Brand Active Pharmaceutical Ingredient US Expiration EP Expiration

Avastin Bevacizumab 2019 2022

Herceptin Trastuzumab 2019 2014

Humira Adalimumab 2016 2018

Erbitux Cetuximab 2016 2014

Remicade Infliximab 2018 2015

Rituxan Rituximab 2018 Expired

Enbrel Etanercept 2028 2015

Aranesp Darbepoetin Alfa 2024 2016

Neulasta Pegfilgrastim 2015 2017

USD 110

Billion in

2014

Patent Expiry

worth USD

67 Billion by

2020

Market of

Biologics

would reach to

USD 250

Billion by 2010

CAGR: 15%


Our Research Methodology


Our Research Methodology (cont’d)

Secondary Source Information:

• Clinical Trial Registry of India (CTRI)

• Central Drug Standard Control Organisation (CDSCO)

• Drug Controller General of India (DCGI)

• Clinical Trials Websites

• Annual Reports and Investor Reports of Companies

• Newspapers, Magazines, Journals, Articles and etc.

Confirmation through Primary Information:

• Clinicians involved in the trial/ Principal

investigator

• Clinical Trial Coordinator

• Target Company’s R&D Coordinator, Spokes

person, Medical Director etc.

• Marketing and Business Development Team

• Other Business Analyst and Experts

• Clinicians involved in the trial/ Principal

investigator

• Clinical Trial Coordinator

• Target Company’s R&D Coordinator, Spokes

person, Medical Director etc.

• Marketing and Business Development Team

• Other Business Analyst and Experts

Analysis

Triangulation of information

Report Preparation


Therapy Area and Indications Evaluated

Therapy Area Active Pharmaceutical

Ingredient (API)

Indication/s Evaluated Total companies

evaluated in the study

Oncology Monoclonal Antibodies (mAb)

Trastuzumab Metastatic Breast Cancer 8

Rituximab Non-Hodgkin’s Lymphoma 6

Bevacizumab Metastatic Colorectal

Cancer

Metastatic Non-Squamous

Non-Small Cell Lung

Cancer

5

Cetuximab Metastatic squamous cell

carcinoma of the head and

neck cancer

1


Therapy Area and Indications

Evaluated


Ingredient (API)

Indication/s

Evaluated

Total companies

evaluated in the

study

Oncology Tyrosine-kinase inhibitor (TKI)

Lapatinib Metastatic Breast Cancer 1

Sorafenib Hepatocellular Carcinoma,

Renal Cell Carcinoma and

Differentiated thyroid

carcinoma

1

Sunitinib 1

Dasatinib Chronic myeloid leukemia

(CML)

1

Others

Ixabipilone Metastatic or locally

advanced breast cancer

1

Peg-Filgrastim Chemotherapy induced Netropenia

4


Therapy Area and Indications

Evaluated (cont’d)


Ingredient (API)

Indication/s Evaluated Total companies

evaluated in the

study

Immunology Monoclonal Antibodies (mAb)

Rituximab Rheumatoid Arthritis 4

Infliximab Rheumatoid Arthritis 3

Adalimumab Rheumatoid Arthritis 5

TNF-alpha inhibitor

Etanercept Rheumatoid Arthritis 3

Nephrology Darbepoetin Chronic Kidney Disease

(CKD)

3

Ophthalmology Ranibiziumab Age-related macular

degeneration (AMD)

1


Current Rituximab Landscape in India

Source: Clinical Trial Registry of India (CTRI) and other secondary sources

Company Brand Approved Indication

in India

Dosage, Strength and

Pricing Structure (Maximum

Retail Price)

Dr Reddy's Laboratories

Limited

Reditux Non-Hodgkin’s Lymphoma 100 mg (1x10 ml) Vial: Rs. 9,999

500 mg (1x50 ml) Vial: Rs. 39,996

Emcure Pharmaceuticals

Limited

Ikgdar Non-Hodgkin’s Lymphoma 100 mg (1x10 ml) Vial: Rs. 7,500

500 mg (1x50 ml) Vial: Rs. 37,500

Intas Pharmaceuticals

Limited

Mabtas Non-Hodgkin’s Lymphoma 100 mg (1x10 ml) Vial: Rs. 34,900

500 mg (1x50 ml) Vial: Rs. 6,500

Roche Products (India)

Private Limited

Ristova Non-Hodgkin’s Lymphoma 100 mg (1x10 ml) Vial: Rs. 7,500

500 mg (1x50 ml) Vial: Rs. 37,500


Rituximab Biosimilars in Pipeline

Landscape

Source: Clinical Trial Registry of India (CTRI) and other secondary sources

Company Product Code Indication/s

Evaluated

Current Stage of

Development

Expected launch in India

Hetero Drugs

Limited

Rituximab

(HCR/III/Ritux/06/

2012)

Non-Hodgkin’s

Lymphoma

Phase III Between Q3 2015 t0 Q1, 2016

Company 2 Xx Xx Xx Xx




Company 6 Xx xx xx Xx


Content of Coverage*

• Study Details

– Type of Trial

– Study Type

– Study Design

– Study Title

– Objective

– Indication evaluated

– Patients recruited

– Clinical trial sites

– Primary outcome

– Secondary outcome

– Brief summary

• Clinical Trial Details

– Stage of development

– Target Market

– Date of enrolment (India)

– Date of enrolment (Global)

• Clinical Trial Details (cont’d)

– Estimated duration of trial

– Expected launch in India

– Method Generating random sequence

– Method of concealment

– Binding Masking

– Recruitment status

– Comparator Agent

• Ethics Committee and Clinical Trial Centres

– Clinical Trial Centres

– Ethics Committee

– Investigator

• Inclusion criteria

• Exclusion criteria

*Based on the available information


Study Details

Header Description

Name of API and

Product Code

Rituximab (HCR/III/Ritux/06/2012 Version 1.1 dated 01Nov2012)

Name of company Hetero Drugs Limited

Type of Trial Interventional

Study Type Biological

Study Design Randomized, Parallel Group, Active Controlled Trial

Study Title A Randomized, Multiple-dose, Multicenter, Comparative Parallel Study To Evaluate The

Efficacy, Safety And Pharmacokinetic Characteristics Of Intravenous Infusion Of

Rituximab (Hetero) And Reference Medicinal Product (Rituximab, Roche) In Indian

Patients Of Non-Hodgkins Lymphoma (HERILY Study)

Objective To study the effects of Rituximab injection (Hetero) in Indian patients suffering from

varieties of Non-Hodgkin’s Lymphoma.

Indication evaluated Non-Hodgkin’s Lymphoma

Patients recruited 150

Clinical trial sites 30

Primary outcome Overall Response rate (ORR) by International Working Group (IWG) response criteria.

Time points: At baseline, end of cycle 3 and 6.

Source: Clinical Trial Registry of India (CTRI) and other relevant secondary sources


Study Details (cont’d)

Header Description

Secondary outcome Pharmacodynamics: CD19 counts Pharmacokinetics: Cmax, Tmax & AUC

Immunogenicity: Anti-Rituximab antibodies Safety: Adverse events-significant clinical

signs, symptoms & laboratory abnormalities during treatment

Time points: Pharmacodynamics: Baseline, end of cycle 3 and 6 Pharmacokinetics:

Cycle 1 and 6 Immunogenicity: Baseline, end of cycle 3 and 6

Brief summary This study is an open label, randomized, multiple-dose, parallel study to evaluate the

safety and efficacy of intravenous infusion of Rituximab Test product (Hetero) and

Reference product in two clinical subtypes of Non-Hodgkin’s lymphoma (DLBCL &

follicular) given along with CHOP chemotherapy. The primary objective is to compare the

antitumor efficacy of Hetero-Rituximab with Reference Medicinal Product (Rituximab,

Roche). The secondary objectives are to evaluate safety of the patients, compare the

immunogenic potentials from baseline to the end of 3rd & 6thcycles of chemotherapy, to

evaluate the pharmacokinetic characteristics at 1st & 6th cycles of chemotherapy, and

compare the pharmacodynamics from baseline to the end of 3rd & 6th cycles of

chemotherapy, between two formulations of Rituximab (test and reference).



Clinical Trial Details

Header Description

Stage of development Phase III

Target Market India

Date of enrolment (India) August 2013

Date of enrolment (Global) NA

Estimated duration of trial 2 Years

Expected launch in India Between Q2 2015 t0 Q4, 2015

Method Generating random

sequence

Computer generated randomization

Method of concealment Centralized

Binding Masking Open Label

Recruitment status Open to recruitment

Q1: Jan-Mar; Q2: Apr-Jun; Q3: Jul-Sep; Q4: Oct-Dec



Clinical Trial Details (cont’d)

Type Name Details

Intervention Rituximab (Hetero) Rituximab (Hetero) 375 mg/m2 should be

administered on Day 1 of each chemotherapy

cycle in combination with cyclophosphamide,

doxorubicin, vincristine and prednisolone (CHOP)

for 6 cycles

Comparator Agent Rituximab (Roche) Rituximab (Roche) 375 mg/m2 should be

administered on Day 1 of each chemotherapy

cycle in combination with cyclophosphamide,

doxorubicin, vincristine and prednisolone (CHOP)

for 6 cycles



Ethics Committee and Clinical Trial

Centres

Clinical Trial Centre Ethics Committee Investigator

Acharya Tulsi Regional Cancer Treatment &

Research Institute, Bikaner (Rajasthan)

Institutional Ethics committee,Acharya tulsi

regional cancer treatment & research instituteDr Surinder Beniwal

Apollo Gleneagles Cancer Hospital, Kolkata

(West Bengal)

Institutional Ethics committee, Apollo

Gleneagles Cancer Hospital

Dr Prabrajya

Mohapatra

Apollo Hospitals, Hyderabad (Andhra

Pradesh)Ethics Committee, Apollo Hospitals Dr SVSS Prasad

Basavatarakam Indo American Cancer

Hospital& Research Institute, Hyderabad

(Andhra Pradesh)

Institutional Ethics committee, Basavatarakam

Indo American Cancer Hospital& Research

Institute

Dr Krishna Mohan

Batra Hospital & Medical Research Centre,

New Delhi (Delhi)

Ethical and scientific review committee,

Batra Hospital & Medical Research CentreDr Kunjahari Medhi

BGS Global Hospital, Bangalore (Karnataka)Institutional Ethics committee, BGS Global

HospitalDr Ganesh Dev

Chirayu Medical College & Hospital, Bhopal

(Madhya Pradesh)

Institutional Ethics committee, Chirayu Medical

College & HospitalDr Tarini Prasad Sahoo

Chittranjan national cancer institute, Kolkata

(West Bengal)

Institutional Ethics committee, Chittranjan

national cancer institute

Dr Kalyan Kusum

Mukherjee

Dayanand Medical College & Hospital,

Ludhiana (Punjab)

Ethics committee,Dayanand Medical College &

HospitalDr Jagdev Singh




Centres (cont’d)


Dr. Saroj Gupta Cancer Centre Welfare Home and

Research Institute, Kolkata ( West Bengal)

Institutional Ethics committee, Dr. Saroj

Gupta Cancer Centre and Research

Institute

Dr Rabindranath Ghosh

HCG Cancer Centre, Ahmadabad (Gujarat) HCG Multi speciality Ethics committee Dr Ashish M Kaushal

Jaslok Hospital & Research Centre, Mumbai

(Maharashtra)

Institutional Ethics committee, Jaslok

Hospital& Research CentreDr Suresh H Advani

Kashyap Nursing Home, Mumbai (Maharashtra)Fortis Hiranandani Hospital Ethics

committeeDr Nilesh Lokeshwar

KEM Hospital, Pune (Maharashtra)

Ethics committee of KEM Hospital

Research

centre

Dr Minish Jain

King George Hospital, Visakhapatnam (Andhra

Pradesh)

Institutional Ethics Committee, King

George Hospital Dr P Ravi Mohan

King George Medical University, Lucknow (Uttar

Pradesh)

Institutional Ethics committee,King

George Medical UniversityDr Vijay Kumar

Lakshya Cancer Day Care Centre, Pune

(Maharashtra)O and P Institutional ethics committee Dr Sachin Hingimire




Centres (cont’d)


MNJ Institute of Oncology & Regional Cancer

Canter, Hyderabad (Andhra Pradesh)

Institutional Ethics committee,MNJ

Institute of Oncology & Regional Cancer

Center

Dr Sudha Sinha

Netaji Subhash Chandra Bose Cancer Research

Institute, Kolkata (West Bengal)

Ethics committee, Netaji Subhash

Chandra Bose Cancer Research

Institute

Dr Asis Mukhopadhyay

NRS Medical College & Hospital, Kolkata (West

Bengal)

Institutional Ethics committee, NRS

Medical College & HospitalDr Tuphan Kanti Dolai

Omega Hospitals, Hyderabad (Andhra Pradesh) Axon Institutional ethics committee Dr PS Dattatreya

Onco Centre, Mumbai (Maharashtra) Fortis Hospital Ethics committee Dr Boman Nariman

Queen’s NRI Hospital, Visakhapatnam (Andhra

Pradesh)

Institutional Ethics committee, Queen’s

NRI HospitalDr Lalit Varadapande

R.K Birla Cancer Centre, Jaipur (Rajasthan)Institutional Ethics committee,R.K Birla

Cancer CentreDr Sandeep Jasuja

Rajiv Gandhi Cancer, institute & Research

Centre, Rohini (Delhi)

Institutional review board, Rajiv Gandhi

Cancer institute & Research CentreDr Dinesh Bhurani




Centres (cont’d)


Rushil Cancer and Endocrine Care, Ahmadabad

(Gujarat)Sangini Hospital Ethics Committee Dr Bhavesh Parekh

Sir Ganga Ram Hospital, New Delhi (Delhi)Institutional Ethics committee, Sir Ganga

Ram HospitalDr Shyam Agarwal

St. John’s Medical College Hospital, Bangalore

(Karnataka)

Institutional Ethics committee, St. John’s

Medical College HospitalDr Ross Cecil Reuben

Lazarus Hospitals Limited, Hyderabad (Andhra

Pradesh)Axon Institutional ethics committee- Dr Jayanthi

Meher Onco Care, Hyderabad (Andhra Pradesh) Axon Institutional ethics committee Dr Meher Lakshmi



Inclusion Criteria

Header Description

Age 18-65 Years

Gender Both (Male and Female)

Details • The patient willing to give written, signed, and dated informed consent to participate in the

study before initiating any study related procedures

• Male or Female 18 years and 65 years of age (both inclusive)

• Histologically confirmed CD20-positive- Newly diagnosed diffuse large B-cell Non-Hodgkin’s

lymphoma OR Previously untreated patients with stage III-IV follicular lymphoma in

combination with chemotherapy

• Patients who are eligible for rituximab and CHOP

• Patients with at least one measurable lesion as per International Working Group Response

Criteria for Malignant Lymphoma

• Adequate liver, renal, cardiac and haematological functions

• Subjects with a performance status of 0 to 2 according to the Eastern Cooperative Oncology

Group (ECOG)

• Life expectancy more than six months

• No other serious illness that according to investigator might jeopardize the well-being, the

safety of study subjects, the compliance to study medications and validity of data generated

during the study.



Exclusion Criteria

Header Description

Details • Hypersensitivity reactions with murine proteins or planned chemotherapy • Diffuse lymphoma

for which CHOP is not adequate therapy

• Bulky Disease (10 cm on maximum dimension) or involves 1/3 of chest diameter (on

radiographic imaging)

• Need for emergency therapy such as neurologic compression syndrome • Subjects with CNS

involvement or CNS lymphoma (Diffuse large B-cell lymphoma that is primary CNS,

effusional, or intravascular according to the WHO, 2008 classification)

• Patient treated with prior chemotherapy including not limited to Anthracyclines, Rituximab,

anti-CD-20 therapy or autologous or allogeneic stem cell transplantation

• Any radiotherapy given for lymphoma or non-lymphoma before 30 days of planned treatment

• Symptomatic peripheral neuropathy (Grade 2,Common Terminology Criteria of Adverse

Events [CTCAE]

• Patients using systemic antibiotic therapy 30 days prior to screening



Status and Cost

Report is ready Cost of Report: USD 6,000

100% advance to purchase the report

Write to us: [email protected]

mailto:[email protected]

Health & Medicine

A Report on Pipeline of Biosimilars in India 2015