Biosimilars/Research

Progress in the regulation of biosimilars in the EU

Biosimilars/Research | Posted 12/11/2021

Analysis of regulation of biosimilars in the EU concludes that regulation is progressing as more knowledge is gained, which is reflected in the changing nature of regulatory guidelines. The authors conclude that the EU framework generates safe and effective biosimilars [1].

Biosimilars, clinical management and incentives

Biosimilars/Research | Posted 12/11/2021

The aim of a study carried out by Spanish researchers was to identify and analyse policies applied in the health services to enhance uptake of biosimilars in the framework of clinical management settings [1]. Incentives, both financial and non-financial, were of particular interest for the authors. They reviewed the relevant experiences developed in different high-income countries with advanced healthcare systems. In addition, they investigated barriers to the implementation of these policies in Spain.

YLB113 etanercept biosimilar autoinjector 'safe and effective’

Biosimilars/Research | Posted 05/11/2021

Analysis of the YLB113 etanercept autoinjector, a biosimilar to reference etanercept, finds a high rate of injection success and supports the safe and effective use of YLB113 [1].

Progress for bevacizumab copy biologicals from Henlius and Innovent

Biosimilars/Research | Posted 05/11/2021

Shanghai Henlius Biotech, Inc (Henlius) reports progress in clinical trials of a bevacizumab copy biological for age-related macular degeneration and colorectal cancer, while Innovent Biologics reports positive findings from a trial of their bevacizumab copy biological in hepatocellular carcinoma.

Data support the interchangeability of EU biosimilars

Biosimilars/Research | Posted 29/10/2021

The first study to comprehensively analyse post-marketing surveillance data for biosimilar monoclonal antibodies demonstrates comparable efficacy, safety and immunogenicity with the originator products [1].

Patent litigation insights on barriers to US biosimilar market growth

Biosimilars/Research | Posted 29/10/2021

High prices of biological drugs have placed substantial strain on the US healthcare system. To help address this problem, Congress passed the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) as part of the Affordable Care Act, which created an abbreviated approval pathway for biosimilars – versions of ‘originator’ biological drugs made by different manufacturers. To resolve disputes over whether a biosimilar manufacturer would infringe patents on the originator biological by entering the market, the BPCI Act included a multi-step litigation process, which starts when the biosimilar manufacturer submits its abbreviated biological license application to the US Food and Drug Administration (FDA). However, a decade after its passage, the BPCI Act has spurred only limited competition [1].

Research, development and public production of pharmaceuticals in Argentina

Biosimilars/Research | Posted 22/10/2021

Under the current research and development model, the pharmaceutical industry has switched its focus towards the therapeutic areas that offer the greatest commercial benefit, which are often not aligned with public health needs. Consequently, it has ceased to be the great innovative industry that it had been during the last century.

Delayed biosimilars market entry costs US billions

Biosimilars/Research | Posted 22/10/2021

Delayed adalimumab biosimilar entry to the US market is estimated to have cost Medicare over US$2.19 billion between 2016 and 2019, a study published in Clinical Pharmacology and Therapeutics has revealed.

Demand for similar biotherapeutic products in Latin America

Biosimilars/Research | Posted 02/07/2021

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].

Competition from biosimilars drives price reductions for biologicals in France

Biosimilars/Research | Posted 15/10/2021

The US has experienced a policy debate as to whether competition from biosimilars is the best strategy for achieving price reductions for biologicals or, rather, whether direct price regulation after loss of patent exclusivity would be more effective. In order to investigate this issue, authors from the US and France combined quantitative and case study methods to examine in detail the interaction between market and administrative mechanisms to reduce biologicals’ prices in France. In their article they present comprehensive data on market shares and prices for three major biologicals and their 11 competing biosimilars between 2004 and 2020 [1].