Biosimilars

Biosimilars and interchangeability in oncology

Researchers from Brazil investigated, from a pharmaceutical perspective, a major problem of the present time, which is the interchangeability of biosimilars [1].

Biosimilars approved in Costa Rica

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

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

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

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

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

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

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.

Biosimilars of insulin aspart

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

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

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

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

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

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

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?

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

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 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

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

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

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].

PANLAR issues consensus statement on biosimilars

PANLAR presented its position on biosimilar medicines at its own congress in Argentina. Via the consensus statement, the PANLAR specialists seek to demonstrate the efficacy, pharmacovigilance, regulation, quality and safety of biosimilar medicines.

Biosimilars in Spain: balance between innovation and health public expenditure

Biosimilars have been marketed in the European Union (EU) for 13 years. Due to uncertainties about substitutability and interchangeability, their commercialization has been criticised. 

Biosimilars in Japan: an overview

No regulations on interchangeability exist in Japan and switching between a reference product and biosimilar is often impractical, according to a letter recently published in The Lancet Oncology [1].

Canada approves rituximab biosimilar Riabni

Canada’s drug regulator, Health Canada, has approved the rituximab biosimilar Riabni for the treatment of rheumatoid arthritis as well as chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma.

Regulatory landscape for similar biotherapeutic products in Latin America

Most Latin American countries are in the process of or have already established their own regulatory guidelines for similar biotherapeutic products (SBPs), and there are regional recommendations on how to ensure the safety and efficacy of biosimilars.

Biosimilar pipelines for South Korean firms: LG Chem and GC Pharma

Biosimilar makers from South Korea are making their mark, not only in South Korea, but around the world when it comes to biosimilars. Celltrion Healthcare (Celltrion) and Samsung Bioepis (Samsung and Biogen’s joint venture) are already becoming major players in the world of biosimilars. While, other Korean companies, such as LG Chem Life Sciences (LG Chem) and GC Pharma (formerly Green Cross) are also expanding their biosimilar pipelines.

Biosimilar epoetin in the US – barriers and recommendations

A review of biosimilar epoetin, which is used to treat cancer and chemotherapy-induced anaemia, shows variable uptake in the US. The authors conclude that safety and pricing considerations are the primary determinants of uptake and make recommendations to increase usage [1].

Canada approves pegfilgrastim biosimilar Nyvepria

Canada’s drug regulator, Health Canada, has approved the filgrastim biosimilar Nyvepria (PF-06881894). The drug can be used to treat neutropenia (a lack of white blood cells) in cancer patients.

Demand for similar biotherapeutic products in Latin America

Development of biologicals has experienced steady growth over the past three decades. Expiration of patents on many originator biologicals, such as insulin, human growth hormone and erythropoietin, has opened the door for the development of biosimilars. The high cost of biologicals, however, has limited their accessibility, particularly in developing countries. Biosimilars offer much-needed affordability and hence improved accessibility. Global health agencies, such as the World Health Organization, are engaged in developing a prequalification program in order to help countries that do not have strong regulatory systems [1].

US biosimilars information guides and support for cancer biosimilars

Pharmaceutical giant, Pfizer, and the Cancer Support Community, in the US, have published guides to biosimilars. In addition, Pfizer is collaborating with The National Comprehensive Cancer Network® (NCCN®) to fund projects to support innovation related to appropriate biosimilar adoption in oncology.

Local level biosimilar prescribing proactivity revealed in Italy

Italian local healthcare authorities are highly proactive regarding actions on prescribing behaviour for off-patent biologicals, reveals a study published in GaBI Journal [1]. However, work needs to be done to appropriately reallocate resources gained through patent expiration. 

Biobadamérica promotes the use of biological and biosimilar drugs in Latin America

In 2007, the Spanish Society of Rheumatology (Sociedad Española de Reumatología, SER) created the Biobadamérica, an international collaborative project to promote the implementation of national safety registries for the use of biological and biosimilar drugs in Latin American countries [1]. 

Measures to promote the use of biosimilars

How to increase the uptake of biosimilars is an important issue both in Europe and across the world. Europe, via its centralized European Medicines Agency (EMA), has been very successful in approving biosimilars. There are currently 73 biosimilars approved in Europe, almost all of which were marketed immediately after approval [1]. Despite the success in approving and marketing biosimilars, the uptake of biosimilars does vary between different countries in Europe. To encourage the use of biosimilars, targets and incentives have been used across Europe [2]. However, pricing can also play an important role and was investigated by Josep Maria Guiu Segura and Antoni Gilabert Perramon [3].

Prices for arthritis biologicals in Latin America

Analysis of the prices of biological and biosimilar drugs used to treat rheumatoid arthritis suggests these drugs are more accessible in Spain than in Latin America, but least affordable in the US [1].

FDA accepts application for Lupin’s pegfilgrastim biosimilar

India-based generics manufacturer Lupin Pharmaceuticals (Lupin) announced on 2 June 2021 that the US Food and Drug Administration (FDA) had accepted the application for approval for its proposed pegfilgrastim biosimilar.

New data on adalimumab biosimilars from Samsung Bioepis and Boehringer Ingelheim

Recently published data show that switching to Samsung Bioepis adalimumab
biosimilar Imraldi is safe and effective, while data from Boehringer Ingelheim suggest their adalimumab biosimilar, Cyltezo, could be classed as interchangeable.

The role of the patient in treatments with biosimilars in Argentina

This is how Dr Eduardo Mysler, Medical Director for the Research Medical Organization (OMI) and rheumatology specialist with a long research career reflects that ‘patients have to understand all the details of their disease’.

Trastuzumab emtansine ‘similar biologic’ Ujvira launched in India

India-based generics manufacturer Zydus Cadila (Zydus) announced on 24 May 2021 the launch of its trastuzumab emtansine ‘similar biologic’ Ujvira in India. The launch, according to Zydus ‘marks the world’s first biosimilar antibody drug conjugate (ADC) of trastuzumab emtansine’. 

Positive phase III results for tocilizumab biosimilar BAT1806

US biotechnology company Biogen Idec (Biogen) and China-based Bio-Thera announced on 1 June 2021 positive phase III data for their tocilizumab biosimilar, BAT1806. According to the two companies, ‘the comparative study met its primary endpoints and showed equivalent efficacy and comparable safety profile in patients with moderate-to-severe rheumatoid arthritis’.