Biosimilars/News

Canada approves infliximab and filgrastim biosimilars Avsola and Nivestym

Biosimilars/News | Posted 10/07/2020

Canada’s drug regulator, Health Canada, has approved the infliximab and filgrastim biosimilars Avsola (ABP 710) and Nivestym.

Revance and Mylan move forward with Botox biosimilar

Biosimilars/News | Posted 10/07/2020

US firm Revance Therapeutics (Revance) announced on 1 June 2020 that its partner, US-based drugmaker Mylan, had decided to move forward with a development plan, under a 351(k) pathway, for a proposed biosimilar to Allergan’s cosmetic blockbuster Botox and Botox Cosmetic (onabotulinumtoxinA).

Japanese approval for first adalimumab biosimilar

Biosimilars/News | Posted 03/07/2020

Japan-based Fujifilm Kyowa Kirin Biologics announced on 29 June 2020 that it had received approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its adalimumab biosimilar FKB327 in Japan.

EC approval for etanercept biosimilar Nepexto

Biosimilars/News | Posted 03/07/2020

The European Commission (EC) has granted marketing authorization for the etanercept biosimilar Nepexto (YLB113), developed by US-based drugmaker Mylan and its partner India-based generics maker Lupin.

China approves bevacizumab copy biological Byvasda

Biosimilars/News | Posted 26/06/2020

China-based drugmaker Innovent Biologics (Innovent) announced on 19 June 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had approved Byvasda (IBI-305), a bevacizumab copy biological.

Canada approves pegfilgrastim biosimilar Ziextenzo

Biosimilars/News | Posted 26/06/2020

Canada’s drug regulator, Health Canada, has approved the pegfilgrastim biosimilar Ziextenzo (LA-EP2006). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

Daewon launches teriparatide biosimilar in South Korea

Biosimilars/News | Posted 19/06/2020

South Korea-based Daewon Pharmaceutical (Daewon) announced that it has launched the teriparatide biosimilar Terrosa.

China accepts IND application for denosumab copy biological HLX14

Biosimilars/News | Posted 12/06/2020

China-based drugmaker Shanghai Henlius Biotech (Henlius) announced on 27 May 2020 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), had accepted an investigational new drug application (IND) for HLX4, a denosumab copy biological.

Bio-Thera launches first adalimumab copy biological in China

Biosimilars/News | Posted 21/02/2020

Bio-Thera Solutions (Bio-Thera) announced in January 2020 the launch of the first adalimumab copy biological in China. The drug can be used to treat rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis and will be marketed as Qletli.

Mabpharm files infliximab copy biological application in China

Biosimilars/News | Posted 31/01/2020

US-based biopharmaceutical company Sorrento Therapeutics (Sorrento) announced on 6 January 2020 that its partner, China-based Mabpharm, had filed a marketing application with China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) for its infliximab copy biological (CMAB008).

FDA approves insulin glargine biosimilar Semglee

Biosimilars/News | Posted 19/06/2020

US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 11 June 2020 that it had received approval from the US Food and Drug Administration (FDA) for its insulin glargine biosimilar Semglee (MYL‑1501D).

Fresenius Kabi’s pegfilgrastim biosimilar accepted for review by EMA and FDA

Biosimilars/News | Posted 12/06/2020

Fresenius Kabi, the generics unit of German healthcare giant Fresenius, announced on 22 and 27 May 2020 that the regulatory submissions for its proposed pegfilgrastim biosimilar (MSB11455) had been accepted by both the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA), respectively.

EMA recommends approval of trastuzumab biosimilar Zercepac

Biosimilars/News | Posted 05/06/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 29 May 2020 that it had recommended granting of marketing authorization for a biosimilar trastuzumab product.

Teva launches rituximab biosimilar Truxima in US

Biosimilars/News | Posted 05/06/2020

Israeli generics giant Teva Pharmaceutical Industries (Teva) and partner, South Korean biotechnology company Celltrion, announced on 4 May 2020 that they had launched their rituximab biosimilar Truxima (TL011) in the US.

Denosumab copy biological clinical trial application accepted in China

Biosimilars/News | Posted 27/03/2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has accepted a clinical trial application of denosumab copy biological HLX14.

Canada approves rituximab biosimilars Riximyo and Ruxience

Biosimilars/News | Posted 22/05/2020

Canada’s drug regulator, Health Canada, has approved the rituximab biosimilars Riximyo (GP2013) and Ruxience (PF-05280586) for the treatment of rheumatoid arthritis as well as chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma.

EMA recommends approval of Sanofi’s insulin aspart biosimilar

Biosimilars/News | Posted 15/05/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 30 April 2020 that it had recommended granting of marketing authorization for an insulin aspart biosimilar.

Pegfilgrastim biosimilar Fulphila launched in Canada

Biosimilars/News | Posted 08/05/2020

US-based drugmaker Mylan and partner, India-based biologicals specialist Biocon, announced on 28 April 2020 the launch of their pegfilgrastim biosimilar, Fulphila, in Canada. This is the second biosimilar from the pair to be launched in the country.

Celltrion files application with EMA for adalimumab biosimilar