Dong-A has achieved therapeutic equivalence for its ustekinumab biosimilar candidate DMB-3115 in clinical studies and now plans to file for marketing authorization for the product in both the EU and US.

The latest Generics Bulletin Top 50 ranking of global generics and biosimilars companies sees a new name in the top five amid transformations for some of the leading off-patent players. Meanwhile, a number of mid-level firms shift position and newcomers climb into the bottom of the table.

Plus deals involving Dong-A/Polifarma, Intas/Syna, Kissei/Synmosa, Ono/Memo, Takeda/Shionogi, Fosun/Lilly and JW Therapeutics/2seventy bio.

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.