Biosimilars/News
Pegfilgrastim biosimilar Lapelga approved in Canada
Canada-based Apotex received approval for its pegfilgrastim biosimilar, Lapelga, from Health Canada with positive decision made on 5 April 2018. This marks the first pegfilgrastim biosimilar to be approved by the Canadian medicines regulator.
FDA approves epoetin alfa biosimilar Retacrit
The US Food and Drug Administration (FDA) approved its first epoetin alfa biosimilar on 15 May 2018.
Biosimilar etanercept Eucept approved in South Korea
South Korea-based LG Chem has obtained regulatory approval to begin marketing and selling its etanercept biosimilar in Korea.
FDA rejects trastuzumab and rituximab biosimilars
US pharma giant Pfizer announced on 23 April 2018 that the US Food and Drug Administration (FDA) had rejected its application for approval of its trastuzumab biosimilar. Then Sandoz, part of Novartis, announced on 2 May 2018 that its biosimilar rituximab application had also been rejected.
Australia approves rituximab biosimilar Truxima
South Korean biotechnology company Celltrion announced on 23 April 2018 that Australia’s regulatory body, the Therapeutic Goods Administration (TGA), has approved its rituximab biosimilar, Truxima (CT‑P10).
FDA rejects Celltrion/Teva’s rituximab and trastuzumab biosimilars
South Korean biotechnology company Celltrion announced on 6 April 2018 that it had received complete response letters (CRLs) from the US Food and Drug Administration (FDA) regarding its candidate rituximab (CT‑P10) and trastuzumab (CT‑P6) biosimilars.
EMA approval for infliximab biosimilar Zessly
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 March 2018 that it had recommended granting marketing authorization for the infliximab biosimilar Zessly.
EMA approval for trastuzumab biosimilar Kanjinti
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 23 March 2018 that it had recommended granting marketing authorization for the trastuzumab biosimilar Kanjinti.
Insulin biosimilar Semglee gains EC and Australian approval
India-based Biocon and US-based partner Mylan announced on 28 March 2018 that they had received European Commission (EC) and Australian approval for their co-developed insulin glargine biosimilar, Semglee.
Trastuzumab biosimilar Ontruzant launched in the UK
Merck Sharp and Dohme (MSD), which is known as Merck in the US and Canada, announced on 8 March 2018 that it had launched the trastuzumab biosimilar, Ontruzant, in the UK.
