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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].

Bioequivalence of bevacizumab biosimilar (BEVZ92) versus Avastin in mCRC patients

Researchers from mAbxience presented data that supports the pharmacokinetic (PK) bioequivalence between bevacizumab biosimilar BEVZ92 and originator bevacizumab (Avastin) as first-line treatment in combination with fluorouracil, leucovorin and oxaliplatin (FOLFOX) or fluorouracil, leucovorin, and irinotecan (FOLFIRI).  in patients with metastatic colorectal cancer (mCRC) [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.

Increase in use of biosimilar rituximab for NHL treatment

Researchers from the UK and US reported on how the treatment approach for non-Hodgkin lymphoma (NHL) patients has changed since the first biosimilars of rituximab were approved in the European Union five (EU5: France, Germany, Italy, Spain, UK) [1].

Comparison of biosimilar and originator bevacizumab in NSCLC

A study carried out by international researchers reported results from a comparative clinical study of PF‑06439535, a candidate bevacizumab biosimilar compared to originator bevacizumab, in patients with advanced non-squamous non-small cell lung cancer (NSCLC) [1].