Biosimilars/News
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.
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).
Tanvex BioPharma submits filgrastim biosimilar to Health Canada
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
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
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
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
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.
