Biosimilars

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).

Bio-USER survey highlights the perception of retina specialists about biosimilars

Biosimilars/Research | Posted 06/04/2023

The International Biosimilar Retina Study Group (Inter-BIOS Study Group) has recently published the results of the largest survey of biosimilar awareness amongst retina specialists practicing in the US and Europe [1]. The Survey was targeted at 200 retina specialists (100 from the US and 100 from Europe) and 112 retina specialists (55 from the US and 57 from Europe) responded. These results were presented at the 22nd Euretina Congress held in Hamburg, Germany [2], and also at the American Academy of Ophthalmology 2022 Annual Meeting held in Chicago, USA [3]. Following were the major findings of this survey:

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.

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.

Challenges for Spanish generics and biosimilars industry: sustainable profitability

Biosimilars/General | Posted 31/03/2023

Spain's generics and biosimilars industry is calling for their profitability to be guaranteed after authorities lowered the reference prices of over 1,000 drugs.

Low biosimilar uptake in regions of low social and political trust

Biosimilars/Research | Posted 23/03/2023

The adoption of biosimilars is lower in regions experiencing low social and governmental trust, finds a recent study that focused on uptake in provinces of Italy and Germany [1].

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.

Lilly, Novo Nordisk and Sanofi slash prices of insulin in the US

Biosimilars/General | Posted 23/03/2023

In March 2023, major insulin manufacturers Eli Lilly (Lilly), Novo Nordisk and Sanofi announced price reductions of 70%, 75% and 78% respectively, for their most commonly prescribed insulins in the US, starting from first quarter of 2023 for Lilly and from 1 January 2024 for Novo Nordisk and Sanofi. The three companies control over 90% of the global insulin market.

American College of Rheumatology position statement on biosimilars updated

Biosimilars/General | Posted 16/03/2023

In late 2022, the American College of Rheumatology (ACR) issued a position statement on biosimilars [1] in which they emphasized their strong belief that safe and effective treatments should be available to patients at the lowest possible cost. This is an update of previous position statements [2].

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.

A global overview of manufacturers of follow-on biologicals

Biosimilars/Research | Posted 16/03/2023

Recently, the World Health Organization (WHO) has pointed out that the absence of appropriate regulatory frameworks for biosimilars may have led to the approval of follow-on biologicals that cannot be considered biosimilars according to current WHO biosimilar guidelines, which were coined ‘non-innovator biologicals’ by WHO. In order to investigate the existence of ‘non-innovator biologicals’ in global markets, more understanding of the structure of the market and the manufacturers that are active in this field is needed.

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).

Study supports increased development of insulin biosimilars

Biosimilars/Research | Posted 03/03/2023

Biosimilar insulins appear to be satisfactory in the treatment of both type 1 and type 2 diabetes and there is a strong case for increasing biosimilar insulin development, finds an editorial published in the Journal of Diabetes [1].

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.

Malaysian hospital pharmacists’ perspective on and role in promoting biosimilars use

Biosimilars/Research | Posted 24/02/2023

This survey study carried out by Mohd Sani N et al. aimed to evaluate Malaysian pharmacists’ perspectives of biosimilars and to determine factors associated with pharmacists successfully promoting their use.

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.

Survey demonstrates US pharmacist biosimilar knowledge gaps

Biosimilars/Research | Posted 17/02/2023

Previous studies of stakeholder perceptions have primarily focused on physicians. However, pharmacists are key stakeholders in the use and adoption of biosimilars. The study carried out by Stevenson et al. sought to gain insights from US pharmacists about their knowledge and approach to the use of biosimilars.

DARS: advancing biosimilar development in the US

Biosimilars/Research | Posted 10/02/2023

This article reviews the recent engagement of the Division of Applied Regulatory Science (DARS) in several current initiatives on utilizing pharmacodynamic (PD) biomarkers to demonstrate biosimilarity, potentially streamlining or negate the need for comparative clinical studies.

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.