Reports

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.

More pro-biosimilar healthcare policies and RWE studies in the US

Home/Reports | Posted 01/12/2022

A 2022 report entitled ‘The U.S. Journey and Path Ahead’ provides perspective on where the US biosimilars industry stands today and what is expected in the future. The publication brought together the latest industry data on biosimilar utilization and payer coverage with survey data from healthcare providers, and thoughts from physicians and experts on biosimilars.

Humira (adalimumab) biosimilars pipeline

Home/Reports | Posted 18/11/2022

A large range of biosimilars of the anti-inflammatory drug Humira (adalimumab) are expected to flood the market in 2023. There could be as many as 10+ biosimilar competitors on the market by the end of 2023, based on current US Food and Drug Administration (FDA) approvals and pending applications [1].

New and upcoming biosimilars launches in the US

Home/Reports | Posted 04/11/2022

This article provides a summary of newly approved biosimilars and an update on the biosimilar pipeline and those biosimilars in the approval process.

CNMC study on the wholesale medicines market in Spain: biosimilar medicines

Home/Reports | Posted 21/10/2022

The National Commission for Markets and Competition (Comisión Nacional de los Mercados y la Competencia, CNMC), the body that promotes and preserves the proper functioning of all markets in the interest of consumers and businesses in Spain, published on 22 June 2022 a study on the regulation of medicine prices in the country, which analyses its main problems and puts forward several recommendations to improve the functioning of the sector, including that of biosimilars, for the benefit of consumers and public health. The research focused on medicines sold through pharmacies.

Challenges of biosimilar medicines in France

Home/Reports | Posted 14/10/2022

After reviewing the key figures [1] and the incentive measures [2] to promote the use of biosimilars in France, Nadia Amer, speaker at BIOS 22 and Health Economics Analyst at Health Product Department of CNAM, presented the challenges that are faced and that leave still much room for improvement for biosimilar uptake in France [3].

Incentives promoting use of biosimilar medicines in France

Home/Reports | Posted 07/10/2022

During the presentation at BIOS 22, speaker Nadia Amer described the key figures of biosimilar medicines in France [1], and addressed the incentive measures promoting the use of biosimilar drugs, which have been implemented in France, mostly since 2018 [2].

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.