Artículos patrocinados

Increasing regulatory focus on orthogonal analytical characterization for biosimilars

INICIO/Artículos patrocinados | Posted 03/03/2021

Author: Fiona M Greer, BSc (Hons), MSc, PhD, Independent Consultant

Abstract
Debate continues on the requirement for different types of data to demonstrate biosimilarity, with some regulators expressing expectations of a future without large expensive comparative efficacy studies. Proposed changes of regulatory emphasis reinforce the importance of choosing orthogonal analytical techniques to interrogate quality attributes (QA) when assessing biosimilarity.

Keywords: Biosimilar testing, biosimilarity, characterization techniques, orthogonality, regulatory requirements

Introduction
Evolution of biosimilar guidelines
For some time now, a hot topic of discussion has concerned the types of data, non-clinical and clinical, required for demonstration of biosimilarity and the ability of analytical characterization to provide an accurate understanding of originator and biosimilar molecules, in turn arguably reducing the need for large phase III clinical trials.

Next generation processing of monoclonal antibodies

INICIO/Artículos patrocinados | Posted 24/02/2017

Author: Jennifer Campbell; Christopher Gillespie, PhD; Michael Phillips, PhD

The biosimilars market continues to expand, with forecasts for significant market penetration, as already evidenced in regions where biosimilars have been on the market for years [1]. The premise of biosimilars is affordable health care, with the hope of expanding accessibility to populations previously not served by biological medicines [2]. In this endeavour, developers of biosimilars are targeting dramatically reduced costs of goods (CoGs). They must compete with originators who manufacture drugs in large stainless steel facilities, with the benefit of economies of scale. Most biosimilar molecules will be manufactured at scales at or below 2,000 L and primarily leverage single-use platforms [3]. This presents a conundrum for cost reduction as the cost of goods for the 2,000 L single-use solution is often considerably higher than the 10,000 stainless steel solution. In order for biosimilars to effectively compete on economics, they will need to take advantage of new technologies that offer both performance and cost advantages.

Sourcing innovator products in the age of biosimilar research

INICIO/Artículos patrocinados | Posted 29/05/2015

Author: Michael Cohen, BSc, MBA

Abstract
Sourcing innovator drugs is a critical and complex component of biosimilar research. Understanding the challenges and conducting thorough upfront planning are crucial in ensuring success.

Keywords: Innovator drug sourcing challenges

Legislations on biosimilar interchangeability in the US and EU – developments far from visibility

INICIO/Artículos patrocinados | Posted 29/05/2015

Author: Phani Kishore Thimmaraju, BPharm; R Rakshambikai, PhD; Raheem Farista, MPharm; Karthaveerya Juluru, MPharm

Abstract
With the rising healthcare expenditure, biosimilars are projected as a cost-effective solution yet retaining clinical properties as the originator drugs. However, the true potential of biosimilars would be realized only when it attains the status of interchangeability, wherein, the two drug forms may be substituted with one another at the level of the pharmacy. The legislations that govern such substitutions are non-uniform, with only a few countries currently working towards such guidelines. Various stakeholders influence the drivers and barriers that entangle this space. The article critically evaluates different parameters and their influence on biosimilars uptake. 

Keywords: Biosimilars, interchangeability, legal issues, legislations, patient accessibility, regulations