Biosimilars/News

EMA recommends approval of bevacizumab Lytenava

Biosimilars/News | Posted 22/05/2024

On 21 March 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization (MA) for Outlook Therapeutics’ Lytenava (ONS-5010, bevacizumab gamma), intended for treatment of neovascular (wet) age-related macular degeneration (nAMD).

Three more biosimilar approvals in Canada in 2023

Biosimilars/News | Posted 14/05/2024

In Canada, three biosimilars were approved in late 2023. These are, Amgen’s Wezlana (ustekinumab), JAMP/Alvotech’s Jamteki (ustekinumab), and Formycon/Polpharma Biologics/Bioeq’s Ranopto (ranibizumab).

EMA recommends approval of first omalizumab biosimilar Omlyclo

Biosimilars/News | Posted 07/05/2024

On 21 March 2024, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorization for Omlyclo (omalizumab), Celltrion's biosimilar of the reference product Xolair.

China approves first denosumab copy biological Maiweijian

Biosimilars/News | Posted 16/04/2024

On 3 April 2024, China-based biopharmaceutical company Mabwell announced that their Maiweijian (denosumab) injection, developed by its wholly owned subsidiary T-mab, obtained the marketing approval from China’s National Medical Products Administration (NMPA). This product is the first denosumab copy biologicalto receive marketing approval in China.

EMA recommends approval of first denosumab biosimilar Jubbonti and Wyost

Biosimilars/News | Posted 09/04/2024

On 21 March 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Sandoz’s medicinal products, Jubbonti and Wyost (denosumab), which are biosimilars of Amgen’s reference products Prolia and Xgeva, respectively. 

First denosumab biosimilars approved in Canada and the US

Biosimilars/News | Posted 03/04/2024

The first and only denosumab biosimilars for osteoporosis and increasing bone mass were approved in Canada and the US in February and March 2024.

Dr Reddy's launches bevacizumab biosimilar Versavo in the UK

Biosimilars/News | Posted 27/03/2024

On 19 March 2024, Dr Reddy’s Laboratories announced that it would be launching Versavo, a bevacizumab biosimilar, in the UK.

EMA recommends approval of ustekinumab biosimilar Pyzchiva

Biosimilars/News | Posted 22/03/2024

On 22 February 2024, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Pyzchiva (ustekinumab), a biosimilar of reference product Stelara.

FDA approves interchangeable adalimumab biosimilar Simlandi

Biosimilars/News | Posted 11/03/2024

On 23 February 2024, the US Food and Drug Administration (FDA) approved Alvotech and Teva’s Simlandi (adalimumab-ryvk) injection as an interchangeable biosimilar to AbbVie’s Humira (adalimumab).

EC approval of ranibizumab biosimilar Rimmyrah

Biosimilars/News | Posted 07/03/2024

The European Commission (EC) granted marketing authorization for ranibizumab biosimilar Rimmyrah on 5 January 2024. The biosimilar was developed by Qilu Pharma.