Biosimilars/News

EC biosimilar approvals: Omlyclo, Jubbonti/Wyost, and Pyzchiva

Biosimilars/News | Posted 03/07/2024

The European Commission (EC) granted marketing authorization for four biosimilars. They are Celltrion’s Omlyclo (omalizumab), Sandoz’s denosumab biosimilars Jubbonti and Wyost, and Samsung Bioepis’ Pyzchiva (ustekinumab). Furthermore, the EC approves expanded indication for Samsung Bioepis' Epysqli (eculizumab) to include treatment of atypical haemolytic uremic syndrome (aHUS).

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.

FDA approves first tocilizumab biosimilar Tofidence

Biosimilars/News | Posted 17/10/2023

On 29 September 2023, the US Food and Drug Administration approved Tofidence (tocilizumab-bavi) as the first biosimilar to Actemra (tocilizumab). Tofidence is first-of-its-kind biosimilar tocilizumab to receive approval in the US.

EC approval of trastuzumab biosimilar Herwenda

Biosimilars/News | Posted 23/01/2024

The European Commission (EC) granted marketing authorization for trastuzumab biosimilar Herwenda on 15 November 2023. The biosimilar of Herwenda is developed by EirGenix, Inc.

EC approval of first ustekinumab biosimilar Uzpruvo

Biosimilars/News | Posted 16/01/2024

On 5 January 2024, the European Commission (EC) granted marketing authorization for the first ustekinumab biosimilar Uzpruvo (AVT04). The biosimilar of Uzpruvo is developed by Iceland-based biosimilar manufacturer Alvotech.

Alvotech: rejection AVT02 in the US and new partnerships with Prolifarma and Advanz Pharma

Biosimilars/News | Posted 03/08/2023

The US Food and Drug Administration (FDA) rejected Alvotech’s biologicals licence application (BLA) for their biosimilar adalimumab AVT02 in June 2023. Alvotech has also formed new partnerships with Prolifarma and Advanz Pharma for proposed biosimilars to Eylea (aflibercept) and Xolair (omalizumab), respectively.

Rinvoq approved to treat Crohn’s disease in Europe

Biosimilars/News | Posted 27/04/2023

On 17 April 2022, AbbVie announced that its Rinvoq (upadacitinib) had received European Commission (EC) approval. It is the first and only oral Janus Kinase (JAK) inhibitor approved to treat moderately to severely active Crohn's disease in adult patients. Rinvoq has the potential to rival AbbVie’s own blockbuster drug, Humira (adalimumab) and its biosimilars for inflammatory autoimmune conditions [1].

EMA recommends approval of ranibizumab biosimilar Rimmyrah

Biosimilars/News | Posted 12/12/2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use announced on 9 November 2023 that it had recommended granting of marketing authorization for Rimmyrah (ranibizumab), a biosimilar that references ophthalmology drug, Lucentis.

FDA approves Zymfentra and advances for Yuflyma in the US

Biosimilars/News | Posted 05/12/2023

On 23 October 2023, the US Food and Drug Administration (FDA) approved Celltrion’s Zymfentra (infliximab-dyyb) biosimilar as the first subcutaneous (SC) formulation of infliximab. In addition, Celltrion USA signed a contract with Ventegra to add Yuflyma (adalimumab-aaty) as a preferred formulary product in both public and private insurance markets.

EC approval of natalizumab, aflibercept and tocilizumab biosimilars

Biosimilars/News | Posted 28/11/2023

In September 2023, the European Commission (EC) granted marketing authorization for the biosimilars of Tyruko (natalizumab), Yesafili (aflibercept), and Tyenne (tocilizumab).

EMA recommends approval of first ustekinumab biosimilar Uzpruvo

Biosimilars/News | Posted 14/11/2023

On 9 November 2023, the European Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Uzpruvo (ustekinumab), a biosimilar of reference product Stelara, intended for the treatment plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis and Crohn’s disease in adults.

FDA approves first interchangeable ustekinumab biosimilar Wezlana

Biosimilars/News | Posted 07/11/2023

On 31 October 2023, the US Food and Drug Administration (FDA) approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases.

Alvotech biosimilars: FDA ustekinumab application rejection; adalimumab interchangeability designation re-submission

Biosimilars/News | Posted 31/10/2023

In October 2023, Iceland-based biosimilar manufacturer Alvotech, announced that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) for Alvotech’s Biologics License Application (BLA) for AVT04, a biosimilar candidate to Stelara (ustekinumab). As such, the application was not approved. This follows Alvotech’s September 2023 resubmission of a BLA for their high-concentration biosimilar formulation to AbbVie’s blockbuster arthritis treatment Humira (adalimumab), AVT02 [1], following receipt of a similar CRL.

Japanese approval for first ustekinumab biosimilar

Biosimilars/News | Posted 24/10/2023

Iceland-based biosimilar manufacturer Alvotech announced on 25 September 2023 that its commercialization partner in Japan, Fuji Pharma Co Ltd (Fuji) had received marketing approval from Japan’s medicines regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), for its ustekinumab biosimilar AVT04 in Japan.

FDA grants interchangeable designation to adalimumab biosimilar Abrilada

Biosimilars/News | Posted 09/10/2023

US-based pharma giant Pfizer announced on 5 October 2023 that the US Food and Drug Administration (FDA) has designated Abrilada (adalimumab-afzb) as an interchangeable biosimilar to Humira (adalimumab). The interchangeable designation applies to all approved indications of Abrilada, including certain patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.

EMA recommends approval of trastuzumab biosimilar Herwenda

Biosimilars/News | Posted 03/10/2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 15 September 2023 that it had recommended granting of marketing authorization for the trastuzumab biosimilar Herwenda, 150 mg, for intravenous use.

FDA approves first natalizumab biosimilar Tyruko for MS

Biosimilars/News | Posted 14/09/2023

On 24 August 2023, the US Food and Drug Administration approved Tyruko (natalizumab-sztn) as the first biosimilar to Tysabri (natalizumab) for the treatment of adults with relapsing forms of multiple sclerosis (MS). Tyruko is first-of-its-kind biosimilar natalizumab to receive approval in the US.

EMA recommends approval of first natalizumab biosimilar Tyruko for MS

Biosimilars/News | Posted 24/08/2023

On 20 July 2023, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorisation for the medicinal product Tyruko (natalizumab), a biosimilar of reference product Tysabri, intended for the treatment of multiple sclerosis (MS).

China approves bevacizumab copy biological Ankeda

Biosimilars/News | Posted 31/01/2020

China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), announced on 9 December 2019 that it had approved Ankeda, a bevacizumab copy biological.

EMA recommends approval of first aflibercept and tocilizumab biosimilars

Biosimilars/News | Posted 10/08/2023

On 20 July 2023, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorisation for the medicinal product Yesafili (aflibercept), an ophthalmology biosimilar, and Tyenne (tocilizumab), an immunosuppressant used largely for treatment of arthritis.

Coherus: lowest price adalimumab biosimilars announced

Biosimilars/News | Posted 28/07/2023

Coherus BioSciences has announced that it will launch Yusimry, its adalimumab biosimilar, at the lowest price announced to date in the US.