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Next generation processing of monoclonal antibodies

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.

Biosimilar drug development and the importance of analytical characterization

Author: Fiona M Greer, BSc (Hons), MSc, PhD, Global Director, BioPharma Services Development, SGS Life Science Services

Abstract

The development of a biosimilar requires comprehensive physicochemical characterization at many stages of the development pathway. This article reviews the steps that one must follow during the development process.  

Keywords: biosimilarity, biosimilars, head-to-head comparability, physicochemical characterization

Sourcing innovator products in the age of biosimilar research

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

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