Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India

Anurag Rathore

doi:10.5731/pdajpst.2012.00886

EditorialEditorial

Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India

Anurag Rathore

PDA Journal of Pharmaceutical Science and Technology September 2012, 66 (5) 393; DOI: https://doi.org/10.5731/pdajpst.2012.00886

Anurag Rathore

Department of Chemical Engineering Indian Institute of Technology, Delhi Hauz Khas, New Delhi, 110016, India

Find this author on Google Scholar
Find this author on PubMed
Search for this author on this site
For correspondence: journal@pda.org

Article
References
Info & Metrics
PDF

Article Information

vol. 66 no. 5 393

DOI

https://doi.org/10.5731/pdajpst.2012.00886

PubMed

23035022

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online October 3, 2012.

Author Information

Cited By...

11 Citations
Google Scholar

This article has been cited by the following articles in journals that are participating in Crossref Cited-by Linking.

A prospective, randomized, parallel group, double blind, multicenter study to compare the efficacy, safety and immunogenicity of Lupin’s Ranibizumab with Lucentis® in patients with neovascular age-related macular degeneration

Ramandeep Singh, Rohan Chauhan, Ashish Saxena, Anup Shah, Laxshmi Mondal, Dhananjay Bakhle, Chirag Shah, Arpit Shah, Shashank Deoghare, Neelakant Krishnan, Neelima Godse

Indian Journal of Ophthalmology 2022 70 8
Similar biologics in India

Ramesh Jois, Sukumar Mukherjee, S. Rajeswari, P.D. Rath, Vishal Goyal, Disha Gupta

Indian Journal of Medical Research 2020 152 5
Biosimilars: An Approach to some Current Worldwide Regulation Frameworks

Efraín Esteban, Rosa-Helena Bustos, Julio-César García, Edwin Jáuregui

Current Clinical Pharmacology 2019 14 1
Comparison of glycoprofiles of rituximab versions licensed for sale in India and an analytical approach for quality assessment

Tejinder Kaur, Bhupendra Nath Shukla, Vinay Kumar Yadav, Mahesh J. Kulkarni, Alka Rao

Journal of Proteomics 2021 244
Multiple-parallel-protease digestion coupled with high-resolution mass spectrometry: An approach towards comprehensive peptide mapping of therapeutic mAbs

Gauri Pradhan, J.M. Sneha, Babasaheb P. Sonwane, B. Santhakumari, Alka Rao, Mahesh J. Kulkarni

Journal of Proteomics 2021 232
Biosimilars: A Critical Review of Development, Regulatory Landscape, and Clinical Implications

Ankit Monga, Gagan, Pragya Jamwal, Sumit Sharma, Amanpreet Kaur

AAPS PharmSciTech 2025 26 1
Medico-legal aspects in ophthalmology in India

Murali Ariga, Mohana Sinnasamy, NirmalThomas Fredrick, VG Madanagopalan, V Subashini, Tarun Murali

TNOA Journal of Ophthalmic Science and Research 2023 61 3
A prospective, open-label, randomised, parallel design study of 4 generic formulations of intramuscular L-asparaginase in childhood precursor B-cell acute lymphoblastic leukaemia (ALL)

Suja Johnson, Chetan Dhamne, Hari Sankaran, Khushboo A. Gandhi, Pallavi Rane, Nirmaly Roy Moulik, Shraddha Mahesh Jadhav, Murari Gurjar, Gaurav Narula, Shripad Banavali, Vikram Gota

Cancer Chemotherapy and Pharmacology 2022 90 6
Biologics and Biosimilars: Navigating Production, Approval, Applications and Challenges

Nandini Jaynarayan Tiwari, Kantilal B. Narkhede, Anuradha Prajapati, Sachin B. Narkhede, Shailesh Luhar

Asian Journal of Research in Pharmaceutical Sciences 2025
Biosimilars for Cancer Treatment

Satish Shilpi, Ekta Gurnany, Pawan K. Gupta, Kangan Sharma, Khyati Saini, Pranali Chimaniya, Shvetank Bhatt

2024
Efficacy and Safety of Biosimilar Ranibizumab (OPTIMAB®) versus Innovator Ranibizumab in Patients with Neovascular (Wet) Age-Related Macular Degeneration: A Double-Blind, Randomized, Multicenter, Phase III Study

Parth Rana, Himanshu Deshmukh, Urmil Shah, Vinod Kumar, Sanghamitra Kanungo, Deepika Singhal, Santosh Kumar Mahapatra, Ira Vakharia, Mukesh Jaiswal, Ajitkumar Gondane, Pooja Vaidya, Vinayaka Shahavi, Harish Shandilya, Dattatray Pawar, Akhilesh Sharma

Clinical Ophthalmology 2024 Volume 18

PreviousNext

In This Issue

PDA Journal of Pharmaceutical Science and Technology

Vol. 66, Issue 5

September/October 2012

Table of Contents
Index by Author

Download PDF

Article Alerts

User Name *

Password *

Email *

Email Article

Thank you for your interest in spreading the word on PDA Journal of Pharmaceutical Science and Technology.

NOTE: We only request your email address so that the person you are recommending the page to knows that you wanted them to see it, and that it is not junk mail. We do not capture any email address.

Your Email *

Your Name *

Send To *

Enter multiple addresses on separate lines or separate them with commas.

You are going to email the following Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India

Message Subject (Your Name) has sent you a message from PDA Journal of Pharmaceutical Science and Technology

Message Body (Your Name) thought you would like to see the PDA Journal of Pharmaceutical Science and Technology web site.

Your Personal Message

CAPTCHA

This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.

Math question * 8 + 2 =

Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

Citation Tools

Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India

Anurag Rathore

PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 393; DOI: 10.5731/pdajpst.2012.00886

Citation Manager Formats

BibTeX
Bookends
EasyBib
EndNote (tagged)
EndNote 8 (xml)
Medlars
Mendeley
Papers
RefWorks Tagged
Ref Manager
RIS
Zotero

Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India

Anurag Rathore

PDA Journal of Pharmaceutical Science and Technology Sep 2012, 66 (5) 393; DOI: 10.5731/pdajpst.2012.00886

Share This Article:

Tweet Widget
Facebook Like
Google Plus One

Jump to section

Article
References
Info & Metrics
PDF

No related articles found.

PubMed
Google Scholar

Cited By...

No citing articles found.

Google Scholar

Main menu

User menu

Search

Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India

Article Information

Author Information

Cited By...

In This Issue

Citation Manager Formats

Related Articles

Cited By...

More in this TOC Section

Similar Articles

Readers

Author/Reviewer Information

Parenteral Drug Association, Inc.