Lupin And YL Secure Japanese Nod For Etanercept
Executive Summary
Lupin and YL Biologics have obtained approval from Japanese regulator PMDA to manufacture and sell biosimilar etanercept in the region. The firm has also just received GMP certification in the EU for its Indian Pune facility where the drug will be produced.
You may also be interested in...
Lupin Picks Up Canadian Approval For Enbrel Biosimilar
Lupin has celebrated the Canadian approval for its Rymti (etanercept) biosimilar, with all indications matching reference product Enbrel. The product represents the third version of Enbrel approved in Canada.
Lupin Liquidating Japan JV With Yoshindo, Partners With I’Rom For Denosumab Biosimilar
Lupin is liquidating its share in a Japanese biosimilar joint venture with Yoshindo, leading the Indian firm to tie-up with familiar face I’Rom Group to develop and commercialize a biosimilar to Amgen’s Prolia/Xgeva (denosumab) in Japan’s $500m addressable market. Meanwhile, Lupin has also received UK approval for generic Spiriva.
Lupin Liquidating Japan JV With Yoshindo, Partners I’Rom For Denosumab Biosimilar
Lupin is liquidating its share in a Japanese biosimilar joint venture with Yoshindo, leading the Indian firm to tie-up with familiar face I’Rom Group to develop and commercialize a biosimilar to Amgen’s Prolia/Xgeva (denosumab) in Japan’s $500m addressable market. Meanwhile, Lupin has also received UK approval for generic Spiriva.