Biosimilars/News
Japanese approval for Lupin’s etanercept biosimilar
Indian generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 26 March 2019 that its joint venture YL Biologics and Lupin (through its Japanese subsidiary, Kyowa Pharmaceutical Industry) had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its etanercept biosimilar YLB113 in Japan.
Bio-Thera advances bevacizumab and tocilizumab copy biologicals
China-based Bio‑Thera Solutions (Bio‑Thera) has made a licensing agreement for its bevacizumab copy biological and has started a phase III trial for its tocilizumab copy biological.
FDA approves trastuzumab biosimilar Trazimera
Pharma giant Pfizer announced on 11 March 2019 that the US Food and Drug Administration (FDA) had approved its biosimilar version of Roche’s Herceptin (trastuzumab).
China approves rituximab copy biological
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on 22 February 2019 that it had approved Hanlikon, a rituximab copy biological.
UK’s NICE recommends pertuzumab with biosimilar trastuzumab
The UK’s National Institute for Health and Care Excellence (NICE) has recommended originator pertuzumab with intravenous biosimilar trastuzumab and chemotherapy for the treatment of breast cancer.
EC approval for bevacizumab biosimilar Zirabev
US-based drugmaker pharma giant Pfizer announced on 19 February 2019 that it had received European Commission (EC) approval for its bevacizumab biosimilar Zirabev (PF 06439535).
Monoclonal antibody copy biologicals accepted for review in China
China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted applications for approval of two monoclonal antibody copy biologicals (IB 305 and HLX22).
EC approval for pegfilgrastim biosimilar Fulphila
In January 2019, the pegfilgrastim biosimilar, Fulphila, received European Commission (EC) approval.
Three FDA approvals for Glenmark as it enters US branded dermatology market
Glenmark Pharmaceuticals Inc has been granted approval by the US Food and Drug Administration (FDA) for its generic versions of Zytiga, DermOtic oil and Qudexy XR, and has announced its entry into the US branded dermatology segment.
PanGen gains Malaysian approval for epoetin alfa biosimilar
South Korea-based biotechnology company PanGen Biotech (PanGen) announced on 7 February 2019 that Malaysia’s National Pharmaceutical Regulatory Agency has granted sales approval for Erisa, an epoetin alfa biosimilar.
