Menu

Biosimilars/News

China-flag

Bio-Thera gains Chinese approval for adalimumab copy biological and starts ustekinumab trial

Biosimilars/News | Posted 13/12/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has approved Qletli, an adalimumab copy biological. The NMPA has also approved the Investigational New Drug (IND) application from Bio-Thera Solutions (Bio-Thera) to initiate a phase I clinical study for the proposed ustekinumab copy biological BAT2206.

02 AA010638

Australia approves five biosimilars since June 2019

Biosimilars/News | Posted 06/12/2019

Australia’s regulatory agency, the Therapeutic Goods Agency (TGA) has approved five biosimilars since June 2019. The biosimilars approved in the country since then include three pegfilgrastim biosimilars, a trastuzumab biosimilar and a bevacizumab biosimilar.

Stethoscope MD002364 V13F21

Phase III trials started for bevacizumab and natalizumab biosimilars

Biosimilars/News | Posted 06/12/2019

Phase III trials have started for proposed biosimilars of bevacizumab and natalizumab.

48 MD002137

EC approval for subcutaneous infliximab biosimilar Remsima SC

Biosimilars/News | Posted 29/11/2019

South Korean biotechnology company Celltrion Healthcare (Celltrion) announced on 26 November 2019 that it had received European Commission (EC) approval for the subcutaneous (SC) formulation of its infliximab biosimilar (CT-P13) in patients with rheumatoid arthritis (RA).

16704526_l

Lupin to launch etanercept and pegfilgrastim biosimilars in the US

Biosimilars/News | Posted 29/11/2019

India-based generics maker Lupin, which is expecting European approval for its etanercept biosimilar in March 2020, has announced plans to launch the drug on the US market soon after, alongside a pegfilgrastim biosimilar.

MD002152

FDA approves adalimumab biosimilar Abrilada

Biosimilars/News | Posted 22/11/2019

US-based pharma giant Pfizer announced on 18 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its adalimumab biosimilar (PF 06410293).

Bone cells V17C04

Qilu starts phase III trial for denosumab copy biological

Biosimilars/News | Posted 22/11/2019

Chinese pharmaceutical company, Qilu Pharmaceutical (Qilu) is carrying out a phase III clinical trial for a copy biological of Amgen’s Prolia/Xgeva (denosumab).

X-ray1 MD001877 V13E03

Adalimumab copy biological accepted for review in China

Biosimilars/News | Posted 15/11/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted an application for the approval of adalimumab copy biological UBP1211.

Bone cells V17C04

Teriparatide biosimilar Terrosa launched in Europe

Biosimilars/News | Posted 06/09/2019

Hungary-based Gedeon Richter (Richter) announced on 20 August 2019 that it had launched its teriparatide biosimilar Terrosa in Europe immediately following the patent expiry of the reference product in August 2019.

22119008_l

FDA approves pegfilgrastim biosimilar Ziextenzo

Biosimilars/News | Posted 08/11/2019

Sandoz, the generics division of Novartis, announced on 5 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Ziextenzo (LA-EP2006).