Biosimilars/News

EMA recommends approval of biosimilar bevacizumab Avzivi

Biosimilars/News | Posted 25/06/2024

On 30 May 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 Avzivi (bevacizumab), Bio-Thera Solutions’ (Bio-Thera) biosimilar of the reference product Avastin.

FDA approves first interchangeable aflibercept biosimilars to treat macular degeneration

Biosimilars/News | Posted 19/06/2024

On 20 May 2024, the US Food and Drug Administration (FDA) approved Biocon Biologic’s Yesafili (aflibercept-jbvf) and Samsung Bioepis and Biogen's Opuviz (aflibercept-yszy) as the first interchangeable biosimilars to Regeneron and Bayer's Eylea (aflibercept). The Samsung Bioepis product has also been launched in South Korea under brand name, Afilivu.

FDA approves ustekinumab, trastuzumab, and tocilizumab biosimilars

Biosimilars/News | Posted 19/06/2024

In April 2024, the US Food and Drugs Administration (FDA) approved Alvotech and Teva’s Selarsdi (ustekinumab-aekn), a biosimilar to Stelara and Shanghai Henlius Biotech’s Herceptin biosimilar, Hercessi (trastuzumab-strf). This comes after the March 2024 news of the approval of Fresenius Kabi’s Tyenne (tocilizumab-aazg), the first tocilizumab biosimilar with an intravenous and subcutaneous formulation.

Update of biosimilars approved by Health Canada in 2023

Biosimilars/News | Posted 12/06/2024

Since November 2023, Canada’s drug regulator, Health Canada, has approved no fewer than five biosimilars for the treatment of deep vein thrombosis (DVT), cancer, plaque psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis and several serious retinal diseases, such as wet age-related macular degeneration.

EMA recommends approval of biosimilar tocilizumab Tofidence and ustekinumab Wezenla

Biosimilars/News | Posted 05/06/2024

On 25 April 2024, the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two biosimilar medicines: Tofidence (tocilizumab) and Wezenla (ustekinumab), recommending the granting of marketing authorization. This comes following news that Wezlana reached the market in Canada in early March 2024.

Canada approves three more biosimilars in 2022

Biosimilars/News | Posted 28/05/2024

Since the last update in June 2022, Health Canada has approved three more biosimilars (Myxredlin, Rymti, Elonox) in 2022 [1].

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).

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).

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.

Clinical study advances for Alvotech golimumab and Dr Reddy’s rituximab biosimilars

Biosimilars/News | Posted 03/02/2023

In January 2023, Alvotech announced that it has initiated a pharmacokinetic study for AVT05, a biosimilar candidate to Simponi® and Simponi Aria® (golimumab). In addition, Dr Reddy’s Laboratories Ltd announced the successful completion of clinical studies of its proposed rituximab biosimilar candidate, DRL_RI. This is now ready for filing in markets such as the US and Europe.

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.

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.

FDA BLA updates from Celltrion and Accord

Biosimilars/News | Posted 29/02/2024

In January 2024, Celltrion submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for CT-P47, a biosimilar candidate of the reference product Actemra ( tocilizumab). In addition, Accord BioPharma, announced that the FDA accepted its BLA for DMB-311, a biosimilar to Stelara (ustekinumab), approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

FDA approves pegfilgrastim biosimilar Udenyca OnBody autoinjector

Biosimilars/News | Posted 06/02/2024

On 26 December 2023, Coherus BioSciences announced the US Food and Drug Administration’s (FDA) approval of Udenyca OnBody, an on-body injector (OBI) presentation of Udenyca (pegfilgrastim-cbqv), a pegfilgrastim biosimilar administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

FDA approves bevacizumab biosimilar Avzivi

Biosimilars/News | Posted 30/01/2024

On 6 December 2023, the US Food and Drug Administration (FDA) approved China–based manufacturer Bio-Thera Solutions’ bevacizumab biosimilar (BAT1706), Avzivi (bevacizumab-tnjn). This product will be marketed globally by Sandoz.

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