Biosimilars

Biosimilars approved in Costa Rica

Biosimilars/General | Posted 03/09/2021

In Costa Rica, the regulatory body responsible for the approval of biologicals is the Ministry of Health.

Formycon/Bioeq submit European marketing authorization for ranibizumab biosimilar

Biosimilars/News | Posted 03/09/2021

German-headquartered companies Formycon and Bioeq have announced a European marketing authorization application for their ranibizumab biosimilar, FYB201.

Biosimilar interchangeability and emerging treatment strategies for IBD

Biosimilars/Research | Posted 03/09/2021

Biosimilar development and utilization, as well as non-biological oral agents with unique pathological targets, will continue to dominate efforts to improve patient access and reduce the overall cost of care as non-surgical treatments for Crohn’s disease and ulcerative colitis in adults and children. Therapeutic drug monitoring, combined with inflammatory biomarkers, have become the standard of care to assess effectiveness.

Human insulin ‘similar biologic’ InsuTrend launched in India

Biosimilars/News | Posted 27/08/2021

India-based company Anthem Biosciences (AnthemBio) announced that it has launched its human insulin ‘similar biologic’ InsuTrend in India.

Pharmacist-driven biosimilar substitution saves money

Biosimilars/Research | Posted 27/08/2021

A study of pharmacist-driven substitution of brand-name biologicals with biosimilars has shown that this can lead to substantial cost savings in the setting of a community oncology practice.

Alvotech and Celltrion proceed with adalimumab and rituximab biosimilars

Biosimilars/Research | Posted 27/08/2021

Iceland-based Alvotech has reached the primary completion date in a switching study for its adalimumab biosimilar, AVT02, while Celltrion Healthcare has released real-world data on the safety and efficacy of its rituximab biosimilar, Truxima, supporting its use as a treatment for lymphoma.

Biosimilars, innovation in the treatment of chronic disease

Biosimilars/General | Posted 27/08/2021

Biological therapies have meant a significant advance in the way of treating various chronic conditions such as cancer, rheumatoid arthritis, multiple sclerosis. However, they have brought with them high costs for health systems that have been channelled through supply programmes of this type of drugs, in the case of the Dominican Republic, through the High Cost Medicines Programme.

Insulin Aspart Structural Formula V21H27

Biosimilars of insulin aspart

Biosimilars/General | Posted 27/08/2021

Last update: 27 August 2021

Insulin aspart is a type of manufactured insulin used to treat type 1 and type 2 diabetes. It has a more rapid onset and a shorter duration of activity than normal human insulins.

FDA approves first interchangeable insulin glargine biosimilar

Biosimilars/News | Posted 30/07/2021

In a landmark decision, the US Food and Drug Administration (FDA) has approved its first interchangeable biosimilar.

Biosimilars applications under review by EMA – July 2021

Biosimilars/General | Posted 30/07/2021

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (EU). A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.

Canadian study says drug formulary policies do not improve biosimilar uptake

Biosimilars/Research | Posted 30/07/2021

Traditional public drug programme formulary policies alone are not effective in affecting biosimilar uptake, according to a Canadian study published in JMCP [1].

Clinical trials begin for Bio-Thera’s golimumab copy biological

Biosimilars/Research | Posted 30/07/2021

China-based Bio-Thera Solutions (Bio-Thera) have begun a phase III clinical trial for BAT2506, copy biological of the anti-inflammatory molecule Simponi (golimumab).

Quebec announces biosimilar switching policy

Biosimilars/General | Posted 30/07/2021

Quebec, Canada has announced a biosimilar switching policy, which is expected to generate annual savings of CA$100 million at its conclusion in 2022.

Bioequivalence of MYL-1402O to EU- and US-reference bevacizumab

Biosimilars/Research | Posted 30/07/2021

The proposed bevacizumab biosimilar MYL-1402O demonstrated bioequivalence to European Union (EU)- and United States (US)-reference bevacizumab in a pharmacokinetic (PK) study of healthy adult male volunteers.

What drives negative perceptions of biosimilars?

Biosimilars/Research | Posted 23/07/2021

A study of patients taking biological drugs in New Zealand identifies a number of attributes associated with negative perceptions of biosimilars, including being female, seeking information online, and preferring innovator drugs [1].

China approves sintilimab plus bevacizumab copy biological Byvasda

Biosimilars/News | Posted 23/07/2021

China-based drugmaker Innovent Biologics (Innovent) announced on 29 June 2021 that China’s National Medical Products Administration (NMPA), formerly the China Food and Drug Administration (CFDA), has approved the combination drug Tyvyt (sintilimab) plus bevacizumab copy biological Byvasda (IBI-305).

Clinical trials begin for ustekinumab biosimilars

Biosimilars/Research | Posted 23/07/2021

Biosimilars firms BioFactura and Alvotech announce the start of clinical trials for their Stelara (ustekinumab) biosimilars, named BFI-751 and AVT04, respectively.

Biosimilars as a sustainable alternative for complex diseases

Biosimilars/General | Posted 23/07/2021

The use of ‘similar biotherapeutic’ products and ‘biocomparable’ medicines, as biosimilar medicines are named in Colombia and Mexico, respectively, offer a sustainable alternative for health systems, leading to significant savings for payers and health institutions, as well as market opening. Biosimilars thus provide a fair competitive solution.

EMA recommends approval of Samsung Bioepis/Biogen’s ranibizumab biosimilar Byooviz

Biosimilars/News | Posted 16/07/2021

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion for the ranibizumab biosimilar Byooviz (SB11), produced by Samsung Bioepis and commercialized by Biogen.

Switching to biosimilars safe and effective in IBD patients

Biosimilars/Research | Posted 16/07/2021

Multiple adalimumab biosimilars are now approved for use in inflammatory bowel disease (IBD). In fact, to date, 29 June 2021, there are 10 adalimumab biosimilars approved in Europe [1]. However, despite their approval, effectiveness and safety data in IBD remains scarce, according to authors from the UK and The Netherlands [2].