Reports

Key figures of biosimilar medicines in France

Home/Reports | Posted 30/09/2022

At the online session of BIOS 22, Biosimilar medicines: changing patient care pathways, changing outcomes, speaker Nadia Amer, Health Economist Analyst at the Health Product Department in the Caisse Nationale d’Assurance Maladie (CNAM) in France, delivered a presentation based on concrete examples and experiences of biosimilar medicines in France [1].

PBM practices lead US consumers to overpay for generics by 20%

Home/Reports | Posted 01/07/2022

Consumers in the US are overpaying for generics medicines by as much as 20%, a University of Southern California study reports [1]. The white paper calls for transparency across the generic prescription drug supply chain and policies to increase competition and stop anti-competitive practices.

Approaches to streamline biosimilar interchangeable programmes

Home/Reports | Posted 03/06/2022

Dr Yow-Ming Wang provided welcoming remarks during the biosimilars webinar hosted by the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) and the U.S. Food and Drug Administration (FDA).

Brazilian market of biosimilars

Home/Reports | Posted 20/05/2022

As the largest country in South America, Brazil is an important market for the pharmaceutical industry, but the biosimilars still represent less than 2% of the total biological drug market in the country [1].

China–EU market expansion for biosimilars

Home/Reports | Posted 16/05/2022

Hao J stated that the prospects for biosimilar sales in China are huge, but there are many companies in the market battling for share, and so they are slowly turning in the direction of sales abroad, including the European Union (EU). However, in entering the EU they must go up against many large and well-established biopharmaceutical companies. She said that ultimately market share will go to the most efficient and economical producers [1].

Challenges for Chinese companies to bring biosimilars (copy biologicals) to EU

Home/Reports | Posted 06/05/2022

A presentation by Dr Jenny Hao, a pharma operating partner with Converge Partners at the Festival of Biologics meeting in Basel, Switzerland in November 2021, highlights the interest Chinese biosimilars producers have in Europe and the challenges they face.

Pathways for Chinese pharmaceutical companies to enter EU markets

Home/Reports | Posted 29/04/2022

China was significantly behind the European Union (EU) in starting to approve biosimilars/copy biologicals. However, despite the small number of copy biologicals approved in the country, China has been much faster to commercialize such products [1].

Chinese biosimilars (copy biological) in European markets

Home/Reports | Posted 22/04/2022

A presentation entitled ‘International commercialization on biosimilars’ delivered by Dr Jenny Hao of Convergence in November 2021 at the Festival of Biologics meeting in Basel, Switzerland discussed the challenges and opportunities for Chinese biosimilar (copy biological) companies to market their products in the European Union.

Preparing for future biosimilar opportunities

Home/Reports | Posted 08/04/2022

Fifty-five per cent of biosimilar opportunities from loss of exclusivity come from just 10% (13) biologicals, which are concentrated in the oncology space, according to a report released by data analysis firm IQVIA [1].

How biosimilar competition in Europe is changing

Home/Reports | Posted 25/03/2022

A report carried out at the request of the European Commission found that the development of access to biologicals in Europe remains challenging [1].

Developing access to biologicals remains challenging

Home/Reports | Posted 18/03/2022

In a report, carried out at the request of the European Commission, data analysis firm IQVIA, found that the development of access to biologicals in Europe remains challenging [1].

Savings from biosimilars reached an all-time high in 2021

Home/Reports | Posted 11/03/2022

A recent report has highlighted how despite the impact of the COVID-19 pandemic in 2020, the volume of biosimilar prescribing has generated a record high in savings from biosimilar competition.

Comparison of the cost of development of biologicals and biosimilars

Home/Reports | Posted 11/03/2022

The high cost of pharmaceuticals, in the case of biologicals, has a growing impact on healthcare costs worldwide.

Impact of COVID-19 pandemic on biologicals

Home/Reports | Posted 04/03/2022

A report released by data analysis firm IQVIA found that the COVID-19 pandemic has impacted certain segments of the biologicals market, but that, at least in Europe, this has not delayed the approval of new biosimilars [1].

Impact of biosimilar competition in Europe in 2021

Home/Reports | Posted 25/02/2022

A study of 23 European biosimilar markets has found that biologicals are an increasingly important component of pharmaceutical expenditure, due to their efficacy as treatments for complex conditions.

Market outlook for biological medicines in Brazil 2016‒2025

Home/Reports | Posted 18/02/2022

In a report on the role of biosimilars in health care by Professor Dr Claudio Tafla of the University of São Paulo studied the market growth outlook from 2016 to 2025 for biological medicines. Biological medicines currently represent the pharmaceutical industry's largest source of innovation.

Pharmaceutical market of biological and biosimilar medicines in Brazil

Home/Reports | Posted 11/02/2022

According to a report entitled ‘The role of biosimilars in health’ by Professor Dr Claudio Tafla, a physician specializing in emergency medicine from the Pontifical Catholic University of São Paulo in Brazil, biological medicines consume around 40% of the federal public budget for the purchase of medicines in pharmaceutical assistance in the Unified Health System (Sistema Único de Salud, SUS), with rheumatoid arthritis being responsible for the greatest consumption of these resources [1].

Key considerations for PD biomarkers in evaluating biosimilarity

Home/Reports | Posted 17/12/2021

Criteria for PD biomarkers intended to support a demonstration of biosimilarity are inherently different from criteria for surrogate biomarkers used to support new drug approvals.

The ‘positioning’ of PD biomarkers in evaluating biosimilarity

Home/Reports | Posted 10/12/2021

As comparative clinical studies can be costly and time consuming, the US Food and Drug Administration (FDA), is currently conducting research to inform the agency’s thinking on critical aspects of the use of pharmacodynamic (PD) biomarkers to demonstrate biosimilarity. This, according to the agency could either streamline or negate the need for comparative clinical studies.

The role of PD biomarkers in biosimilarity

Home/Reports | Posted 03/12/2021

During the DIA Biosimilars Conference 2021 a presentation entitled ‘An update on the FDA biosimilar program: progress and directions, 2021’ was given by Dr Peter Stein, Director of the Office of New Drugs at the Center for Drug Evaluation and Research (CDER) of the US Food and Drug Administration (FDA). In this presentation, Dr Stein outlined the role that pharmacodynamic (PD) biomarkers have with respect to biosimilars [1].

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