Reports

Follow-on biological/ biosimilar approvals in Latin America by therapeutic class

Home/Reports | Posted 03/04/2024

According to a review by Machado et al., across seven Latin American nations, biosimilar approval patterns diverge from Canada, Europe, and the US. Anti-anaemic and diabetes treatments are notably lacking approvals, while Brazil emerges as a leader in biosimilar authorization [1].

Follow-on biological/ biosimilar approvals landscape in Latin America

Home/Reports | Posted 27/03/2024

Machado et al. analyse the clarity and regulatory guidelines associated with the approval process for biosimilars. Additionally, they examine the quantity of biosimilars that have received approval from 13 different medicines regulatory authorities in their review [1].

Biosimilars in cancer treatment in Europe and the US

Home/Reports | Posted 07/03/2024

The World Health Organization's (WHO) most recent projections suggest a staggering 77% surge in new cancer cases globally by 2050, compared to the approximate 20 million recorded in 2022. As a result, the anticipated number of cancer-related deaths worldwide is poised to double to around 18.5 million by 2050, in contrast to the 9.7 million reported in 2022. Alarmingly, numerous countries still lack sufficient resources allocated to treatment and care services.

First approvals of similar biotherapeutics in seven Latin American countries

Home/Reports | Posted 16/01/2024

In their review, Machado et al. examine the transparency and regulatory guidelines pertaining to the licensing of biosimilars, as well as the count of biosimilars granted approval by 13 medicines regulatory authorities [1].

Biosimilar terminology: insights from seven Latin American countries

Home/Reports | Posted 05/12/2023

In a review by Machado et.al., the authors examine the transparency and guidelines for biosimilars licensing and the number of biosimilars approved by 13 medicines regulatory authorities. In this context, we focused the discussion on seven Latin American countries: Argentina, Brazil, Chile, Colombia, Guatemala, Mexico and Peru as part of the broader review [1].

Biopharmaceutical industry in Argentina in the 21st century

Home/Reports | Posted 31/10/2023

In the dynamic landscape of Latin America's pharmaceutical industry, Argentina stands out with its distinctive structure and policies that have shaped its biopharmaceutical sector. Over the course of this century, the biopharmaceutical industry in Argentina has emerged as a critical player in the country's healthcare sector.

Emerging disparities in market concentration among biosimilars

Home/Reports | Posted 22/09/2023

Biosimilars are an essential element of sustainable healthcare systems, with significant potential contribution to competitive markets. However, there are still challenges to be faced; for instance, there is a growing trend of biosimilar development targeting a limited range of biologicals [1].

Biosimilars uptake rates in Europe and the UK

Home/Reports | Posted 08/09/2023

The rate of uptake of biosimilars has accelerated as stakeholders have become increasingly comfortable with these products [1]. However, the adoption of biosimilars is lower in regions experiencing low social and governmental trust [2, 3].

Non-medical switching of biologicals/biosimilars webinar: Canada, Europe and the US

Home/Reports | Posted 01/09/2023

Biosimilars are now key players in the global drugs market offering potentially more affordable treatment options with similar safety and efficacy. However, there are concerns about non-medical switching practices of originator biologicals/biosimilars in different regions. A webinar was held on 20 July 2022 to discuss non-medical switching practices and to explore the importance of safeguarding the physician–patient relationship [1].

Biosimilar development targets limited range of biologicals

Home/Reports | Posted 01/09/2023

During the Biosimilars Medicines Conference in May 2023, Mr Aurelio Arias from IQVIA delivered a presentation about the biosimilar void in Europe. He highlighted that while the uptake of biosimilars has accelerated, there is a growing disparity in market concentration for smaller biologicals [1].

Biopharmaceutical industry in Brazil in the 21st century

Home/Reports | Posted 18/08/2023

In Brazil, the approach of the Industrial Economic Complex of Health (Complexo Econômico-Industrial da Saúde, CEIS) has been adopted in the planning of policies related to the health economy. This involves the integration of health, industrial and innovative policies.

Biopharmaceutical industry in Argentina and Brazil: a 21st century perspective

Home/Reports | Posted 03/08/2023

The biopharmaceutical industries in Latin American countries have gained significant attention in recent years, with an important growth in Argentina and Brazil where the policies implemented have emphasized collaboration between the public and private sector.

Pharmaceutical companies in China manufacturing copy biologicals

Home/Reports | Posted 20/06/2023

The market for copy biologicals in China has significantly grown over the past decade. The government has been actively promoting the development and use of copy biologicals as a way to improve access to affordable health care. As a result, the number of pharmaceutical companies developing copy biologicals has also increased rapidly and is expected to continue to grow in the coming years.

Biosimilars for chronic disease patients

Home/Reports | Posted 19/05/2023

A report which analyses significant developments in the biosimilar space and the impacts on patient access, affordability and quality of care has been released in early 2023. The report is a product of the Patient Access and Affordability Project, a programme of Patients Rising, a non-profit organization.

Study of the use of generic and biosimilar drugs in Latin America

Home/Reports | Posted 12/05/2023

The results of a study on the knowledge, perceptions and use of generic and biosimilar drugs in Latin America and the Caribbean were recently presented at an event organized by the World Bank during the workshop ‘Rethinking Pharmaceutical Policies in Latin America and the Caribbean’ held in Washington DC, USA.

The successful uptake of biosimilars in Europe and the US

Home/Reports | Posted 09/03/2023

US uptake of biosimilars is now beginning to rival that of Europe. This was a take home message from the June 2022 Alliance for Safe Biologic Medicines (ASBM) webinar on the successful uptake of biosimilars in Europe and the US [1].

Biosimilar monoclonal antibodies in China

Home/Reports | Posted 10/02/2023

Biosimilar monoclonal antibodies (mAbs) are currently a major focus of research and development in China with policies support. mAbs have become crucial therapeutics for treating diseases such as oncology and autoimmune diseases. As competition from biosimilars increases in China, the price of mAbs is decreasing and access to them is increasing.

Biological therapies in patients with rheumatoid arthritis

Home/Reports | Posted 03/02/2023

A study on the estimation of patients with rheumatoid arthritis (RA) as well as those patients who are potentially eligible for the treatment of the disease with biological drugs, was presented by Luca Degli Esposti of CliCon Società Benefit Italy at the 18th Biosimilar Medicines Conference in October 2022.

Highlights of the revised WHO guideline on evaluation of biosimilars

Home/Reports | Posted 13/01/2023

A presentation by Niklas Ekman from the Finnish Medicines Agency during the 18th Biosimilar Medicines Congress in October 2022 in Brussels, Belgium reviewed the key elements of the revised World Health Organization (WHO) Guideline on evaluation of similar biotherapeutic products (SBPs, also called biosimilars) and gave a possible direction for biosimilar regulation in the EU [1].

Estimation of patients potentially eligible to biological therapies

Home/Reports | Posted 12/12/2022

A study on the estimation of patients with psoriasis, rheumatoid arthritis and inflammatory bowel diseases as candidates for biological therapies was presented by Luca Degli Esposti of CliCon Srl Società Benefit Italy at the 18th Biosimilar Medicines Conference which took place in Brussels, Belgium on 6‒7 October 2022.

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