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Clinical and real-world data for switching to biosimilars

The evidence and issues associated with switching from originator biological disease-modifying antirheumatic drugs (DMARDs) to biosimilars are discussed by authors from French universities and hospitals [1].

Mass spectrometry comparison of Remicade and Remsima

The US entered the era of biosimilars in 2015 with its very first US Food and Drug Administration (FDA) approved filgrastim biosimilar Zarxio (filgrastim-sndz) [1]. Since then, FDA has approved 11 more biosimilars [2]. Nevertheless, one concern with respect to the manufacturing of biosimilars is that every company has its own proprietary manufacturing process, which could potentially lead to differences in drug properties. Consequently, the debate on how ‘similar’ the biosimilar is to the originator still remains controversial. Thus, a comprehensive but rapid characterization platform that can validate any clinically meaningful differences is required. In this regard, Pisupati et al. [3] carried out a study comparing the reference product Remicade (infliximab) with the first US monoclonal antibody (mAb) biosimilar Remsima (Europe)/Inflectra (US) by incorporating state-of-the-art mass spectrometry-based multiple-attribute monitoring (MAM).

Switching to etanercept biosimilar SB4 safe and effective in a hospital setting

Authors of a study carried out at a UK hospital found switching to etanercept biosimilar SB4 to be safe and effective [1].

Expediting FDA approvals for biosimilars

A number of recommendations for the US Food and Drug Administration (FDA) to simplify biosimilar licensing laws, and thus make biosimilars more accessible, are offered in a recent review [1]. Recommendations include allowing smaller batch sizes for testing, encouraging substitution for naïve patients, and removing the requirement for bridging studies.

Phase III trial for subcutaneous Remsima completed

Celltrion Healthcare (Celltrion) announced on 29 August 2018 that it had completed a phase III study with the subcutaneous (SC) version of its infliximab biosimilar Remsima (CT‑P13).

Reasons for switching to biosimilars and immunogenicity

Authors from French universities and hospitals discussed the evidence and issues associated with switching from originator biological to biosimilars [1].

Stakeholder perspectives on biosimilars in oncology

Monoclonal antibody biosimilars represent a novel advance in the field of oncology, and their integration into routine clinical practice present challenges for clinicians, nurses, patients and regulators. Researchers therefore investigated the perspectives stakeholders including a clinician, specialist nurse, patient advocate, regulator and economist on optimizing the uptake of monoclonal antibody biosimilars in the treatment of cancer [1].

Pharmacokinetics of CT-P6 in patients with HER2+ early-stage breast cancer

Researchers from Celltrion presented data that support the pharmacokinetic (PK) similarity between trastuzumab biosimilar CT‑P6 and originator trastuzumab (Herceptin) [1].

Recommendations for biosimilars in rheumatology in the Middle East

The increasing availability of biosimilars in Middle Eastern regions may provide an opportunity to increase the number of rheumatology patients who have access to traditionally more expensive biologicals. However, as well as a lack of real-world data on the use of biosimilars in practice, the availability of ‘intended copies*’ in the region may undermine physician confidence in prescribing legitimate biosimilars. There is a need for regional recommendations for healthcare professionals to ensure that biosimilars can be used safely.

Selection of quality attributes and test methods in biosimilarity assessment

Biosimilar development starts with a detailed characterization of the quality profile of the chosen reference product, to establish targets for cell line and process development, according to author Vandekerckhove and colleagues [1]. This characterization requires a careful determination of the range of variability for all relevant product quality attributes of the reference product, as well as an understanding of their relative importance, to ensure appropriate focus on the most important attributes. Following process development, similarity of the biosimilar candidate with the reference product must be demonstrated in comprehensive analytical studies. This first step in the demonstration of biosimilarity provides the most sensitive measurement of differences; and is instrumental in deciding the direction of further product development. Meticulous design of the analytical similarity programme is therefore critical to the success of biosimilar development.