India due to the threat of compulsory licensing and
development of biosimilar Trastuzumab. The Roche Group also launched
another low cost version of Trastuzumab under ... vial.
9. IP-1 initiated the development of a biosimilar drug for Trastuzumab, in joint
collaboration with IP-2, in the year 2008. Manufacturing license
interest of public health and
welfare particularly when the application is for biosimilar wherein, safety and
efficacy is of paramount interest of public health ... welfare. As per
Government Guidelines, any study/trial in relation to biosimilar involves an
element of public interest considering that safety and efficacy
2010 & IT(IT)A.884/B/2013 Page - 7
Biosimilars manufactured in India after undergoing clinical trials,
failed to appreciate that the agreement contemplates ... express
recombinant proteins would be utilised by the appellant to produce the
biosimilars for therapeutic use. The cell lines will undergo characterisation
and process development
subsidiary of Biocon Ltd. engaged in the
development, manufacture and commercialisation of
biosimilar. Assessee filed its original Return of Income on
12/2/2021 which
small size global life sciences
companies, namely, Pharmaceutical, Generics, Medical Device,
Biotechnology, Biosimilar, Consumer Healthcare, Cosmetics in their entire
Regulatory value-chain ranging from Regulatory
news item regarding plans of Reliance life sciences to launch few biosimilar drugs in
India including whether Reliance life sciences has applied for any licenses
separate plant for
manufacture of biological products. The company launched the
biosimilar filgrastim (G-CSF) in India. It was also contended that none
