Biosimilars/News

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).

EC approval for pegfilgrastim biosimilar Fulphila

Biosimilars/News | Posted 22/02/2019

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

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.

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.

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.

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).

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.

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.

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.

CKD Pharma’s darbepoetin alfa biosimilar launched in Japan

Biosimilars/News | Posted 18/01/2019

On 4 December 2018, South Korean drugmaker Chong Kun Dang Pharmaceutical (CKD Pharma) announced that it had received approval for its second-generation anaemia biosimilar, CKD‑11101 (darbepoetin alfa).

EMA approval for bevacizumab biosimilar Zirabev

Biosimilars/News | Posted 11/01/2019

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 13 December 2018 that it had recommended granting marketing authorization for the bevacizumab biosimilar Zirabev.

Trastuzumab and agalsidase beta biosimilars launched in Japan

Biosimilars/News | Posted 11/01/2019

Japanese firms have announced the launch of trastuzumab and agalsidase beta biosimilars in Japan on 28 November 2018.

Biosimilars launched in the US at a significant discount

Biosimilars/News | Posted 14/12/2018

Epoetin alfa and pegfilgrastim biosimilars have been launched in the US at a significant discount compared to their originators.

FDA approves first rituximab biosimilar Truxima

Biosimilars/News | Posted 07/12/2018

On 28 November 2018, the US Food and Drug Administration (FDA) approved its first rituximab biosimilar, Truxima (rituximab-abbs), the first biosimilar for the treatment non-Hodgkin’s lymphoma (NHL).

EC approval for pegfilgrastim biosimilars Pelmeg and Ziextenzo

Biosimilars/News | Posted 30/11/2018

In November 2018, pegfilgrastim biosimilars, Pelmeg and Ziextenzo, received European Commission (EC) approval.

Tanvex BioPharma submits filgrastim biosimilar to FDA

Biosimilars/News | Posted 23/11/2018

Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) announced on 1 October 2018 that it had submitted its first biosimilar application to the US Food and Drug Administration (FDA). The application is for its proposed filgrastim biosimilar TX01.