Biosimilars/News

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.

Celltrion: advances for Yuflyma and Vegzelma biosimilars

Biosimilars/News | Posted 20/06/2023

In the first half of 2023, South-Korea based Celltrion Biologics announced the approval of their Yuflyma (adalimumab-aaty) biosimilar in the US, the winning of a bid to supply Italy and Belgium with bevacizumab biosimilar Vegzelma.

Alkem launches first cetuximab similar biologic in India

Biosimilars/News | Posted 13/06/2023

In May 2023, Alkem Oncology announced the launch of Cetuxa, the fist similar biologic of cetuximab used in the treatment of head and neck cancer. The cetuximab originator was developed by Merck and is sold under the brand name Erbitux.

EMA recommends approval of eculizumab biosimilar Epysqli

Biosimilars/News | Posted 30/05/2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 March 2023 that it had adopted a positive opinion for Epysqli.

Advances for STADA-Xbrane’s Ximluci in Europe, the UK and the US

Biosimilars/News | Posted 04/05/2023

The STADA and Xbrane co-developed Ximluci, ranibizumab biosimilar is to launch in Europe and will now also be available on the UK’s National Health Service (NHS). In addition, the partners have submitted their Biologics License Application (BLA) to the US Food and Drug Administration (FDA).

US and EC approvals for Hyrimoz, US approval for Udenyca autoinjector

Biosimilars/News | Posted 14/04/2023

In March 2023, the US Food and Drug Administration (FDA) approved Sandoz’s Hyrimoz biosimilar, a citrate-free high-concentration formulation (HCF) of adalimumab, as well as Coherus Biosciences’ (Coherus) innovative single-dose, prefilled autoinjector presentation of Udenyca (pegfilgrastim-cbqv).

Biosimilar launches in Canada and US: Byooviz and Stimufend

Biosimilars/News | Posted 31/03/2023

In Canada, Biogen announced that their Byooviz (ranibizumab) injection, a biosimilar of Lucentis, is available as of March 2023. In the preceding month, Fresenius Kabi launched Stimufend (pegfilgrastim-fpgk), a biosimilar of Amgen’s Neulasta, in the US.

EMA recommends approval of eculizumab biosimilar Bekemv

Biosimilars/News | Posted 23/03/2023

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 24 February 2023 that it had recommended granting of marketing authorization for the eculizumab biosimilar Bekemv.

China approves tocilizumab copy biological BAT1806

Biosimilars/News | Posted 16/03/2023

In January 2023, Bio-Thera Solutions announced that the China National Medical Products Administration (NMPA) approved BAT1806, a biosimilar of Actemra (tocilizumab), in China. This is the world’s first tocilizumab copy biological/biosimilar to be approved.

FDA accepts application for denosumab biosimilar GP2411

Biosimilars/News | Posted 09/03/2023

Sandoz, the generics division of Novartis, announced on 6 February 2023 that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for a proposed denosumab biosimilar (GP2411).

EMA accepts application for ustekinumab biosimilar AVT04

Biosimilars/News | Posted 03/03/2023

Alvotech announced on 9 February 2023 that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, their proposed biosimilar to Stelara (ustekinumab).

Ranibizumab biosimilar Ximluci and Amelivu to launch in the UK and South Korea

Biosimilars/News | Posted 24/02/2023

STADA and Xbrane Biopharma have announced that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has granted a marketing authorization for Ximluci, a biosimilar referencing ophthalmology drug, Lucentis (ranibizumab). In addition, Samsung Bioepis and Samil Pharmaceuticals will launch their biosimilar of Lucentis, Amelivu, in South Korea.

New indication for Cosentyx (secukinumab) biological: hidradenitis suppurativa

Biosimilars/News | Posted 19/05/2023

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use adopted a positive opinion on 26 April 2023 recommending Novartis' Cosentyx (secukinumab) to treat active moderate to severe hidradenitis suppurativa (HS) in adults.

Advances for Henlius’ trastuzumab and bevacizumab biosimilars in the US

Biosimilars/News | Posted 20/04/2023

The US Food and Drug Administration (FDA) accepted Henlius' application for HLX02 (biosimilar trastuzumab for injection). Meanwhile, Henlius' multicentre phase III clinical trial (NCT04740671) of HLX04-O (biosimilar bevacizumab) for wet age-related macular degeneration (wAMD) commenced in the US with the first patient dosed.

First African developed biosimilar adalimumab starts phase I trial in Germany

Biosimilars/News | Posted 06/04/2023

A phase I clinical trial of Minapharm Pharmaceuticals’ first African developed adalimumab biosimilar, Adessia, was initiated on 24 February 2023 in Germany with results to be expected at the end of 2023.

Bevacizumab biosimilar Vegzelma approved and Aybintio launched in Canada

Biosimilars/News | Posted 10/02/2023

The bevacizumab biosimilar Vegzelma produced by Celltrion received full label approval from Canada’s drug regulator, Health Canada (HC), on 3 January 2023. Back in November 2022, bevacizumab biosimilar Aybintio by Samsung Bioepis had been launched in Canada by Organon, offering a more affordable treatment for Canadian patients suffering from certain types of aggressive cancer.

Advances for Alvotech’s partnerships in Japan, Canada and Switzerland

Biosimilars/News | Posted 18/11/2022

In October 2022, Alvotech announced new advances with partners Fuji Pharma in Japan and JAMP in Canada. In addition, in September 2022, with its partner STADA, Alvotech announced the launch of Hukyndra, its high-concentration, low-volume, citrate-free formulation, biosimilar to Humira (adalimumab), in Switzerland.

Progress for Lucentis (ranibizumab) biosimilars in Europe and the US

Biosimilars/News | Posted 28/10/2022

On 16 September 2022, Partners Stada Arzneimittel and Xbrane Biopharma announced that the European Medicines Agency’S (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Ximluci, a biosimilar candidate referencing Lucentis (ranibizumab). In addition, on 19 September 2022 in the US, Coherus BioSciences announced that from 3 October 2022, another ranibizumab biosimilar, Cimerli (ranibizumab-eqrn) will be commercially available.

Advances for adalimumab biosimilars in Saudi Arabia, Europe and Canada

Biosimilars/News | Posted 17/02/2023

In January 2023, Alvotech-Bioventure, Sandoz and Samsung Bioepis announced advances for their adalimumab biosimilars in Saudi Arabia, Europe and Canada, respectively.

New insulin glargine and potential adalimumab interchangeable biosimilars

Biosimilars/News | Posted 27/01/2023

The US Food and Drug Administration (FDA) awarded Eli Lilly’s Rezvoglar, an insulin glargine biosimilar, the interchangeable designation in late 2022. This means that in the US, Rezvoglar can now be substituted at the pharmacy level for the originator, Sanofi’s Lantus, without a doctor’s prescription, provided state pharmacy law permits the switch. In addition, a study revealed that Pfizer’s adalimumab biosimilar may also soon achieve this status.

Biosimilar advances for Alvotech-Teva and setback for Biocon Biologics

Biosimilars/News | Posted 20/01/2023

Alvotech and Teva Pharmaceuticals announced in January 2023, that the US Food and Drug Administration (FDA) accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab). Meanwhile, Biocon Biologics received a complete response letter (CRL) from FDAregarding its application for an insulin aspart biosimilar (filed by its partner Viatris).

Advances for Bio-Thera’s secukinumab and mepolizumab copy biologicals

Biosimilars/News | Posted 13/01/2023

China’s Bio-Thera Solutions announced in November 2022 that dosing has begun in a phase III clinical study for BAT2306, a proposed copy biological of arthritis anti-inflammatory treatment, Cosentyx (secukinumab). In addition, the company also recently announced a phase I clinical study to compare the pharmacokinetics and safety of BAT2606, a proposed copy biological of asthma treatment, Nucala (mepolizumab), to US-sourced and EU-sourced reference product in normal healthy volunteers.