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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.

EC approval for pegfilgrastim biosimilars Pelmeg and Ziextenzo

In November 2018, pegfilgrastim biosimilars, Pelmeg and Ziextenzo, 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.

EMA approval for adalimumab biosimilars Idacio and Kromeya

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 January 2019 that it had recommended granting marketing authorization for the adalimumab biosimilars Idacio and Kromeya.

Australia’s PBAC recommends substitution of adalimumab biosimilars

Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) has recommended that the adalimumab biosimilars Amgevita and Hadlima ‘should be treated as equivalent’ to the brand-name biological Humira on the Australian Pharmaceutical Benefits Scheme (PBS).