Biosimilars/News

FDA approves Pfenex’s follow-on teriparatide product

Biosimilars/News | Posted 11/10/2019

US-based biotech firm Pfenex announced on 7 October 2019 that it had received approval from the US Food and Drug Administration (FDA) for its follow-on teriparatide product (PF708).

Biocon/Mylan launch first insulin glargine biosimilar in Australia

Biosimilars/News | Posted 11/10/2019

India-based biologicals specialist Biocon and US-based partner Mylan announced on 3 October 2019 the launch of the first insulin glargine biosimilar in Australia available on the Pharmaceutical Benefits Scheme (PBS).

Three darbepoetin alfa biosimilars approved in Japan

Biosimilars/News | Posted 04/10/2019

Three pharmaceutical companies have announced approval of their anaemia treatments for sale on the Japanese market, while Mochida reveals it will sell the first teriparatide biosimilar in the country.

iBio and CC-Pharming collaborate for rituximab copy biological in China

Biosimilars/News | Posted 04/10/2019

Biotechnology company iBio, self-professed leader in the plant-made pharmaceutical field, announced on 27 August 2019 that it will expand its collaboration with China-based CC-Pharming for a rituximab copy biological in China.

Positive EMA-CHMP opinion for SC infliximab biosimilar

Biosimilars/News | Posted 27/09/2019

South Korean biotechnology company Celltrion announced on 22 September 2019 that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) had recommended for approval the company’s subcutaneous (SC) formulation of its infliximab biosimilar (CT-P13) in patients with rheumatoid arthritis (RA).

Samsung Bioepis to supply Brenzys to Brazil under production development partnership

Biosimilars/News | Posted 27/09/2019

On 10 September 2019, Samsung Bioepis announced that it had signed a productive development partnership (PDP) with Brazil’s Ministry of Health to supply Brenzys, a similar biotherapeutic product to rheumatoid arthritis treatment Enbrel (etanercept), to Brazil for the next 10 years.

Trastuzumab biosimilar Herzuma approved in Canada

Biosimilars/News | Posted 20/09/2019

South Korean biotechnology company Celltrion announced on 10 September 2019 that Health Canada had approved its trastuzumab biosimilar Herzuma.

China approves new formulation of etanercept copy biological Yisaipu

Biosimilars/News | Posted 20/09/2019

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has approved Yisaipu, an etanercept copy biological as a pre-filled syringe.

Herzuma gains Japanese approval for three-week cycle method

Biosimilars/News | Posted 13/09/2019

South Korean biotechnology company Celltrion announced at the end of August 2019 that Japan's Ministry of Health, Labour and Welfare (MHLW) had approved a three-week cycle method for its trastuzumab biosimilar, Herzuma (CT P6), in the treatment of breast cancer.

Revance Therapeutics focus on its own Botox biosimilar as work with Mylan is stalled

Biosimilars/News | Posted 13/09/2019

As Revance gives Mylan more time to decide whether to develop their joint Botox biosimilar, the firm is continuing to focus on its own Botox biosimilar, DAXI. It aims to launch the product in 2020.