Fresenius Kabi and Formycon have seen their filing for an ustekinumab biosimilar rival to Stelara accepted for review by the European Medicines Agency. A filing with the US FDA is also on the way.

Fresenius Kabi has celebrated the approval of Europe’s first tocilizumab biosimilar. The rival to RoActemra is expected to be launched later this year under a settlement agreement with originator Genentech.

CEO of Enzene Biosciences weighs in on the impact of Medicare negotiations in the US on the biosimilars market even as a US filing is planned for a Prolia biosimilar. In the interview, he says Enzene “is not afraid or concerned” over ongoing litigation with Merck KGaA over an Erbitux biosimilar in India, adding that new modalities like ADCs are being “seriously” considered.

Improvements in PFS compared to chemotherapy may help broaden Rybrevant’s indication in EGFR-mutated non-small cell lunger cancer. Investors await data from a head-to-head trial testing it versus AstraZeneca’s Tagrisso.