A commentary published in Value in Health by Dr Sean D Sullivan of the University of Washington School of Pharmacy offers insights into Medicare drug price negotiation [1]. The commentary discusses the implications of negotiation [2] and asks the question, ‘what next?’

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 31 March 2023 that it had adopted a positive opinion for Epysqli.

A study conducted and published by Monte-Boquet E et al. aimed to improve knowledge and use of biosimilar medicines in immune-mediated diseases, and to produce a unified framework for the use of biosimilars [1].

In recent years, Cuba and China have established agreements to develop innovative medical treatments, notably Center for Genetic Engineering and Biotechnology (Centro de Ingeniería Genética y Biotecnología, CIGB)  and Center for Molecular Immunology (Centro de Inmunología Molecular, CIM), and have shared their experiences in the field of medical research.

A study conducted by Welch J et al. assessed the measurement, evaluation and potential for high mannose glycans to impact the pharmacokinetic (PK) profile of biosimilar monoclonal antibodies (mAbs), based on data submitted in 21 applications reviewed and approved by the US Food and Drug Administration (FDA).  They also analysed reproducibility data of the glycan values for a subset of programmes within a reference product class. This reproducibility assessment enabled a broader cross-programme comparison of whether observed differences in high mannose between a proposed biosimilar and its reference product translate into PK differences.

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use adopted a positive opinion on 26 April 2023 recommending Novartis' Cosentyx (secukinumab) to treat active moderate to severe hidradenitis suppurativa (HS) in adults. 

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.

On 21 April 2023, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) issued an updated joint statement on the interchangeability of biosimilars approved in the EU.

A recent publication by Barcina Lacosta et al. reflected on the need to understand market dynamics generated following biosimilars availability in Southern Europe, emphasizing that the competitive potential of biosimilars can be further deployed [1]. Considering the country-, setting-, and product-specific nature of biosimilar uptake patterns [2-5], the authors focused the analysis on hospital tumour necrosis factor alpha (TNF-α) inhibitor markets in Italy, Portugal and Spain [1].

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.