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Biosimilars/News

Cancer Cell V13I20

EC approval for bevacizumab biosimilar Zirabev

Biosimilars/News | Posted 08/03/2019

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).

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Monoclonal antibody copy biologicals accepted for review in China

Biosimilars/News | Posted 01/03/2019

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).

Chemotherapy V13E17

EC approval for pegfilgrastim biosimilar Fulphila

Biosimilars/News | Posted 22/02/2019

In January 2019, the pegfilgrastim biosimilar, Fulphila, received European Commission (EC) approval.

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Three FDA approvals for Glenmark as it enters US branded dermatology market

Biosimilars/News | Posted 22/02/2019

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.

Erythropoietin V13F07

PanGen gains Malaysian approval for epoetin alfa biosimilar

Biosimilars/News | Posted 15/02/2019

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.

Approved V13G05

EMA approval for adalimumab biosimilars Idacio and Kromeya

Biosimilars/News | Posted 08/02/2019

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.

Substitution V13F14

Australia’s PBAC recommends substitution of adalimumab biosimilars

Biosimilars/News | Posted 08/02/2019

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).

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Tanvex BioPharma submits filgrastim biosimilar to Health Canada

Biosimilars/News | Posted 01/02/2019

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) announced on 16 January 2019 that it had submitted a biosimilar application to Health Canada for its proposed filgrastim biosimilar TX01.

Breast cancer V15J22

FDA approves trastuzumab biosimilar Herzuma

Biosimilars/News | Posted 01/02/2019

On 14 December 2018, the US Food and Drug Administration (FDA) approved the trastuzumab biosimilar, Herzuma (trastuzumab-pkrb), for the treatment of patients with human epidermal growth factor receptor 2 (HER2)-overexpressing breast cancer.

Approved V13G05

FDA approves trastuzumab biosimilar Ontruzant

Biosimilars/News | Posted 25/01/2019

On 18 January 2019, the US Food and Drug Administration (FDA) approved the trastuzumab biosimilar, Ontruzant (trastuzumab-dttb), for the treatment of patients with breast and gastric cancer.