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Biocon  /  Businesses  /  Biosimilars  /  Research & Development

BIOCON BIOSIMILARS

Research & Development

Biocon Biologics’ Research and Development organisation is fully integrated to develop high-quality biosimilars (recombinant insulins, monoclonal antibodies and other protein therapeutics) that can be registered in highly regulated markets like USA, Europe and Japan.

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The state-of-art integrated Biocon Research Centre at Bangalore has the following capabilities:

The cell line development facility includes molecular and cell biology laboratories for cloning and expression capabilities, to develop biosimilar cell lines across different microbial and mammalian platforms.

The advanced process sciences laboratories enable scientists to develop phase appropriate, high quality, manufacturing-friendly processes. The cell culture, downstream purification and formulation development teams have scientists and engineers working together to make efficient technologies that ensure production of high-quality drugs.

The drug product development team has established technologies to develop both liquid and lyophilised presentations for both intravenous and sub-cutaneous delivery for patients. Biocon’s extensive experience in development of suspension formulations for recombinant human insulin and insulin analogues puts this team in a unique position in the Biosimilars development space. Our focus on development of high concentration liquid formulations has facilitated Biocon to manufacture next generation biosimilar monoclonal antibodies.

Biologics characterisation facility allows intricate structure function analysis of protein therapeutics. This enables efficient predictive analysis on risk for patient safety and efficacy. Biocon continues to invest aggressively in these facilities to ensure that most sensitive techniques are used to understand the quality attributes of the biosimilar drugs.

Development and validation of bioanalytical assessment platforms that adhere to global regulatory requirements allow for sensitive readouts for drug pharmacokinetics and immunogenicity in biosimilar clinical trials.

Our present focus is on developing sensitive analytical methods to quantitate pharmacodynamic and response biomarkers in clinical samples. This effort is aimed to understand whether surrogate endpoints can be used to moderate clinical trial timelines for establishing biosimilarity.

Data analytics capabilities have allowed enhancement of development functions and bring operational efficiencies in drug development.

The scientists at the Biocon Research Centre have extensive experience in interacting with the United States, European and Japanese regulatory authorities, which has paved the way for the registration of our first wave of biosimilars – Insulin Glargine (Japan, USA and EU), Pegylated G-CSF (USA and EU) and Trastuzumab (USA and EU). Biocon has participated in US FDA workshops to share our extensive experience working with insulin and insulin analogues and scientific rationale to support waiver of safety and immunogenicity studies. Our recent interactions with US FDA along with key opinion leaders in academia and industry have resulted in new draft guidelines for biosimilar and interchangeable insulin and insulin analogues and was published by FDA in November, 2019. This guidance document considers approval of insulins without the need for a safety and immunogenicity study.

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