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Biosimilars/News

Rituximab V13D29

Mabion withdraws application for rituximab biosimilar in EU

Biosimilars/News | Posted 17/04/2020

 Polish biologicals company Mabion Spolka Akcyjna (Mabion) has withdrawn its duplicate applications for its rituximab biosimilar, MabionCD20.

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Amgevita approved in Colombia

Biosimilars/News | Posted 17/04/2020

Colombia’s National Institute of Food and Drug Monitoring (INVIMA – Instituto Nacional de Vigilancia de Medicamentos y Alimentos) has approved the first adalimumab producto bioterapéutico similar (similar biotherapeutic product).

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Merck launches trastuzumab biosimilar in the US

Biosimilars/News | Posted 24/04/2020

US pharma giant Merck (known as MSD outside the US and Canada) and Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced in on 15 April 2020 that they had launched their trastuzumab biosimilar, Ontruzant, in the US.

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EC approval for rituximab biosimilar Ruxience

Biosimilars/News | Posted 24/04/2020

On 2 April 2020, pharma giant Pfizer announced that its rituximab biosimilar, Ruxience (PF‑05280586), had received European Commission (EC) approval.

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Non-originator biologicals approved in Bosnia and Herzegovina

Biosimilars/News | Posted 10/04/2020

Russian biotechnology company Biocad announced on 30 March 2020 that it had received approval for two of its anticancer non-originator biologicals in Bosnia and Herzegovina.

Etanercept V14H14

EMA recommends approval of etanercept biosimilar Nepexto

Biosimilars/News | Posted 03/04/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 27 March 2020 that it had recommended granting of marketing authorization for a biosimilar etanercept product.

Cancer Cell V13I20

Celltrion/Teva launch trastuzumab biosimilar Herzuma in US

Biosimilars/News | Posted 27/03/2020

Celltrion and Teva announced in March 2020 that they have launched their trastuzumab biosimilar Herzuma (trastuzumab-pkrb) in the US. Herzuma can be used to treat breast and gastric cancer and has recently been approved in Canada [1].

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Celltrion launches infliximab biosimilar Remsima SC in Europe

Biosimilars/News | Posted 20/03/2020

In a successful time for Celltrion Healthcare (Celltrion), the company has launched their infliximab biosimilar Remsima in Germany and the UK.

Age-related macular degeneration V15b19

Amgen starts phase III trial for aflibercept biosimilar

Biosimilars/News | Posted 13/03/2020

US-based biotech giant Amgen is initiating a phase III clinical trial for a biosimilar of Regeneron’s Eylea (aflibercept).

Checklist V14A17

FDA accepts application for Mylan’s bevacizumab biosimilar

Biosimilars/News | Posted 06/03/2020

US-based drugmaker Mylan announced on 27 February 2020 that the US Food and Drug Administration (FDA) had accepted its application for its bevacizumab biosimilar (MYL 1402O).

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Mylan launches anti-cancer biosimilar in the US

Biosimilars/News | Posted 21/02/2020

The US drug market receives a new oncology biosimilar as Mylan launches its trastuzumab biosimilar, Ogivri.

Mylan launches anti-cancer biosimilar in the US

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Pfizer launching biosimilars in US and Japan but not in EU

Biosimilars/News | Posted 14/02/2020

In early 2020, pharma giant Pfizer announced that it was launching its rituximab biosimilar in Japan and that it would be launching three new biosimilars onto the US market.

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Phase III trial started in China for eculizumab copy biological

Biosimilars/News | Posted 14/02/2020

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) is starting a phase III clinical trial in China for a copy biological of Soliris (eculizumab), made by Alexion Pharmaceuticals (Alexion).

Checklist Stethoscope V14J24

EMA approval for rituximab biosimilar Ruxience

Biosimilars/News | Posted 07/02/2020

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 January 2020 that it had recommended granting marketing authorization for the rituximab biosimilar Ruxience.

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Rituximab biosimilar ABP 798 submitted to FDA

Biosimilars/News | Posted 07/02/2020

US-based biotech giant Amgen and its partner Allergan announced on 19 December 2019 that their rituximab biosimilar (ABP 798) had been successfully submitted to the US Food and Drug Administration (FDA) for review.

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Teriparatide biosimilar Terossa approved in South Korea

Biosimilars/News | Posted 24/01/2020

South Korea-based Daewon Pharmaceutical has obtained regulatory approval to begin marketing and selling its teriparatide biosimilar in Korea.

Age-related macular degeneration V15b19

Phase I trials started for aflibercept and ustekinumab biosimilars

Biosimilars/News | Posted 15/11/2019

Phase I trials have started for proposed biosimilars of aflibercept and ustekinumab.

South Korean biologicals company Alteogen has, according to clinicaltrials.gov, started a phase I trial for its candidate aflibercept biosimilar ALT-L9.

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Bevacizumab and teriparatide biosimilars launched in Japan

Biosimilars/News | Posted 24/01/2020

Biosimilars for osteoporosis treatment teriparatide and for anticancer drug bevacizumab were launched in Japan in late 2019.

Breast cancer V15J22

Samsung Bioepis and AffaMed to start trastuzumab trial in China

Biosimilars/News | Posted 17/01/2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA) has granted approval for partners Samsung Bioepis and AffaMed Therapeutics (AffaMed) to start a phase III trial for their trastuzumab product, SB3.

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FDA approval for Amgen’s infliximab biosimilar Avsola

Biosimilars/News | Posted 13/12/2019

US-based biotech giant Amgen announced on 6 December 2019 that it had received approval from the US Food and Drug Administration (FDA) for its infliximab biosimilar Avsola (ABP 710).