Generic pharmaceutical BDR Pharma has entered into a royalty-free, limited and non-exclusive voluntary licensing agreement with Eli Lilly and Company, for the manufacturing and distribution of baricitinib for the treatment of Covid-19 in India.
Baricitinib received restricted emergency use approval, for use in combination with remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalised adults and pediatric patients 2 years of age or older, requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
Lilly received permission for restricted emergency use from Central Drugs Standard Control Organisation, a division of Ministry of Health.
This collaboration between BDR and Lilly will increase the availability of baricitinib in India, enhancing local treatment choices and favourably impacting the lives of those fighting COVID-19 in India.
Baricitinib is an oral medication currently registered in India for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs.
“Lilly is committed to supporting India in this healthcare challenge through our innovative and effective portfolio of breakthrough medicines. We are swiftly working to ensure high quality manufacturing and equitable access of Baricitinib for COVID-19 in India,” Lilly India, Managing Director, India Subcontinent, Luca Visini.
Commenting on the development and the royalty-free non-exclusive voluntary license with Lilly, BDR Pharmaceuticals Chairman Dharmesh Shah said, “We are very pleased to partner with Lilly and this is the time to collaborate and fight the COVID-19 pandemic. The concern is to accelerate and harmonise production so that there will not be a shortage of drugs to be administered to individuals fighting the disease.”
BDR has applied for restricted emergency use approval with the Drug Controller General of India (DCGI) for baricitinib for COVID-19 in India. Lilly had recently announced seven voluntary license agreements with major local generic drug manufacturers in India for the production of the same.