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Articles

The BLA includes a comprehensive analytical and clinical data package, including data from the Phase I/III ROSALIA study.

FDA Accepts Biologics License Application for Proposed Biosimilar Denosumab 

Sílvia Helena Cestari de Oliveira is researcher in the biotechnology division at Cristália Produtos Químicos Farmacêuticos, Itapira, Brazil.

Marcos Castanheira Alegria is R&D director at Hypera Pharma.

Marco Antonio Stephano is professor at the University of Sao Paulo, Sao Paulo, Brazil.

This article introduces the requirements for a biosimilar license in Brazil and addresses questions about their quality, safety, and efficacy.

Brazilian Regulation of Biosimilar Products: What Is Important to Know

The European Commission (EC) has approved Celltrion Healthcare's Vegzelma (CT-P16), a biosimilar to bevacizumab referencing Avastin.

European Commission Approves Bevacizumab Biosimilar from Celltrion Healthcare

Mili Pathak is principal scientist, Process Science, R&D, at Intas Pharmaceuticals Ltd. (Biopharma Division), Ahmedabad, Gujarat, India.

Prashant Pokhriyal is associate scientist at Intas Pharmaceuticals Ltd. (Biopharma Division), Ahmedabad, Gujarat, India.

Ronak Patel is principal scientist, R&D, at Intas Pharmaceuticals (Biopharma Division), Ahmedabad, Gujarat, India.

Laxmi Adhikary, PhD, is senior vice-president, R&D, at Intas Pharmaceuticals (Biopharma Division), Ahmedabad, Gujarat, India.

The business impact of modeling and simulation tools is not well understood and requires clarification of their benefits to drug development.

Do Modeling and Simulation Tools Really Benefit the Biosimilar Industry?

Cynthia A. Challener, PhD, is a contributing editor to BioPharm International.

Linking structure with function is paramount.

Method Development for Biosimilar Analysis

Samsung Biologics has signed an agreement with Biogen to acquire Biogen’s 50% stake in Samsung Bioepis, a joint venture formed by the two companies, for up to $2.3 billion.

Samsung Biologics to Acquire Full Ownership of Samsung Bioepis in $2.3 Billion Deal 

 Washington Editor, jillwechsler7@gmail.com.

The Democratic legislative proposal to authorize price negotiations on costly medicines covered by Medicare has drawn opposition from brand pharmaceutical and biotech companies. 

Generic-Drug Makers Also Fight Price Controls

Anurag S. Rathore is a professor in the Department of Chemical Engineering at the Indian Institute of Technology Delhi and a member of 

l's Editorial Advisory Board, Tel. +91.9650770650, asrathore@biotechcmz.com.

Dr. Srishti Joshi is postdoctoral fellows at Centre of Excellence, Biopharmaceutical Technology, Indian Institute of Technology New Delhi.

Dr. Rozaleen Dash are postdoctoral fellows at Centre of Excellence, Biopharmaceutical Technology, Indian Institute of Technology New Delhi.

Neh Nupur is a research scholar at the Department of Chemical Engineering, Indian Institute of Technology New Delhi.

Shravan Sreenivasan is research scholars at the Department of Chemical Engineering, Indian Institute of Technology New Delhi.

The biopharmaceutical landscape of India is transforming in terms of regulatory policies, product development, and affordability.

Emergence of India as a Global Manufacturing Hub for Biosimilars

Editor of Pharmaceutical Technology Europe

The evolution of regulatory guidelines for biosimilars alongside improvements in knowledge and understanding provide a platform for growth in the European market.  

The Evolving Biosimilar Approach

Feliza Mirasol is the science editor for 

Establishing bioassay studies for biosimilar development is important for supporting regulatory filings.

Biosimilars and Biobetters