Sponsored Articles

Front-loading biosimilar development with analytical characterization

Home/Sponsored Articles | Posted 23/09/2022

An online roundtable discussion entitled ‘Front-loading biosimilar development with analytical characterization’ was hosted by BioPharmaSpec. The panellists discussed different regulatory approaches to the clinical trials needed for approval and how this can affect structural and functional characterization; the best way to ‘front-load’ characterization in comparability studies; orthogonality and its role in reducing biosimilar development costs; and how to develop an integrated strategy for structural and functional data assessments.

Quality considerations for analytical methods

Home/Sponsored Articles | Posted 19/05/2022

Author:  Richard L Easton, BSC (Hons), DIC, PhD

Detailed and accurate structural characterization of biopharmaceuticals is of paramount importance for product definition, assessment of impurities and achieving in-depth understanding of manufacturing processes. But how can we have confidence in the data obtained from characterization studies? The expectation from regulatory authorities when assessing methods for product characterization is that there will be some demonstration of their suitability to the task in hand. Here we look at those expectations and what steps can be taken to give confidence to the data produced by these analytical methods.

Keywords: analytical development; mass spectrometry; process related impurities; structural characterization

Increasing regulatory focus on orthogonal analytical characterization for biosimilars

Home/Sponsored Articles | Posted 03/03/2021

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

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

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

Home/Sponsored Articles | 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

Home/Sponsored Articles | Posted 29/05/2015

Author: Michael Cohen, BSc, MBA

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

Home/Sponsored Articles | Posted 29/05/2015

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

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