Biosimilars

FDA approves third aflibercept biosimilar Ahzantive

Biosimilars/News | Posted 13/08/2024

The US Food and Drug Administration (FDA) was busy in June 2024. On 28 June 2024, the FDA granted approval for Formycon’s Ahzantive (aflibercept-mrbb), making it the third approval for a biosimilar referencing Eylea.

Biosimilars in inflammatory bowel disease: are we ready for multiple switches

Biosimilars/Research | Posted 13/08/2024

A review by Teixeira FV et al. discusses whether scientific evidence is sufficient to support multiple switches between biologicals and biosimilars in patients with inflammatory bowel diseases (IBD) [1].

Richmond to launch similar biologicals bevacizumab Yriviak and adalimumab Armixa

Biosimilars/News | Posted 06/08/2024

On 22 July 2024, the Argentina-based Laboratorios Richmond announced the launch of Yriviak, a bevacizumab similar biological, in Argentina. In the coming months, Richmond plans to launch their adalimumab similar biological, Armixa.

China approves Simcare’s cetuximab beta Enlituo

Biosimilars/News | Posted 30/07/2024

On 25 June 2024, Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group based in Nanjing, China, announced that Enlituo, a cetuximab beta injection, had received marketing approval from the China National Medical Administration (NMPA). This new-generation anti-epidermal growth factor receptor (EGFR) antibody drug was developed in collaboration with Mabpharm Limited.

Humira's resilience in the face of biosimilar competition

Biosimilars/General | Posted 30/07/2024

AbbVie’s Humira (adalimumab) has retained more than 80% of patients in the last year (Q3/2023 to Q2/2024), despite the availability of nine lower-priced rival products available in the US. This raises questions among drug pricing experts and analysts about whether the market for prescription biosimilars can survive in its current form.

Topline results from clinical development programme for candidate biosimilar AVT05 golimumab

Biosimilars/Research | Posted 23/07/2024

In April and June 2024, Icelandic biosimilar company Alvotech announced promising results from two clinical studies (AVT05-GL-P01, NCT05632211; AVT05-GL-C01, NCT05842213) for AVT05, their candidate golimumab biosimilar. Alvotech is the first company to announce topline results of clinical trials using a proposed biosimilar to Simponi (Janssen Biotech).

FDA approves third ustekinumab biosimilar Pyzchiva

Biosimilars/News | Posted 16/07/2024

On 28 June 2024, the US Food and Drug Administration (FDA) approved a third ustekinumab biosimilar, Pyzchiva (ustekinumab-ttwe). This product has been developed by Samsung Bioepis and is commercialised by Sandoz. It is a biosimilar of reference product Johnson & Johnson’s (J&J) Stelera.

FDA approves first eculizumab biosimilar Bkemv for two rare diseases

Biosimilars/News | Posted 09/07/2024

On 28 May 2024, the US Food and Drug Administration (FDA) approved Amgen's Bkemv (eculizumab-aeeb), the first biosimilar to AstraZeneca's rare blood disorder treatment Soliris approved in the US.

Efficacy and safety of the proposed P043 (Zerafil) vs reference omalizumab in allergic asthma

Biosimilars/Research | Posted 09/07/2024

In June 2024, the results of a phase III clinical trial of P043/Zerafil (omalizumab), a proposed biosimilar of Novartis’ Xolair produced by CinnaGen in Iran, showed no significant difference in efficacy and safety parameters to the originator.

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).

Tocilizumab and pembrolizumab biosimilar advances for Korean firms

Biosimilars/Research | Posted 03/07/2024

In June 2024, Celltrion announced promising results from their phase III study for CT-P47, a biosimilar candidate of RoActemra (tocilizumab), in patients with rheumatoid arthritis (RA). Additionally, the company has submitted an investigational new drug (IND) application to the US Food and Drug Administration (FDA) for the phase III clinical trial of CT-P51, its Keytruda (pembrolizumab) biosimilar. This announcement follows the news that in April 2024, rival Korean biologicals company Samsung Bioepis initiated a phase III clinical trial for SB27, their pembrolizumab biosimilar.

Boehringer Ingelheim to expand access to adalimumab biosimilar

Biosimilars/General | Posted 03/07/2024

On 13 May 2024, Boehringer Ingelheim (Boehringer) announced an agreement with Quallent Pharmaceuticals, a private label pharmaceutical distributor, to help expand patient access to citrate-free adalimumab-adbm, Boehringer’s biosimilar to AbbVie’s Humira (adalimumab) in the US.

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.

Challenges and progress in the registration of biosimilars in Latin America

Biosimilars/General | Posted 25/06/2024

Biosimilar medicines offer an effective and economical alternative to biotechnological medicines, with a rapidly expanding global market. However, Latin America still faces several significant challenges. The obstacles and advancements experienced in recent years are detailed below.

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.

Canada's path to biosimilar adoption and healthcare accessibility: insights from British Columbia

Biosimilars/General | Posted 19/06/2024

Canada’s British Columbia transitioned to biosimilars in November 2019, achieving significant cost savings reinvested in BC PharmaCare. This initiative has improved drug coverage, expanding access to various medications and medical devices.

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.

Disruption in the US adalimumab market

Biosimilars/General | Posted 05/06/2024

In April 2024, Evernorth Health Services in the US announced that a biosimilar of AbbVie’s Humira ( adalimumab) will be available for US$0 out of pocket for eligible patients of its specialty pharmacy, Accredo. This announcement follows the news that prescriptions for adalimumab biosimilars have spiked to 36% after leading pharmacy benefit manager CVS Caremark removed the branded reference product from its major national commercial formularies in January 2024.