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Biologicals and biosimilar use in Asian patients with IBD

The increasing incidence of inflammatory bowel diseases (IBD) has become a major challenge for gastroenterologists in some Asian countries, particularly China, Japan and Korea. This subject was discussed in the August 2019 issue of the Journal of Gastroenterology and Hepatology [1].

Samsung reveals positive trial results for bevacizumab biosimilar, but admits to failure with rituximab

A phase III trial of Samsung Bioepis’ bevacizumab biosimilar has shown equivalence to reference drug Avastin (bevacizumab). However, the company has admitted to failures in its attempt to develop a rituximab biosimilar at a recent trial in the Seoul Central District Court.

Clinical data requirements for biosimilars in the EU: immunogenicity comparability

The totality of evidence approach for biosimilars in the European Union (EU) was discussed in a review paper [1] using case studies to illustrate biosimilars for which differences were observed in different parts of the comparability exercise and the justification for why these differences did not preclude regulatory approval.

Biosimilars regulation in Canada: state of play

A paper recently published in GaBI Journal provides an update on the regulation and reimbursement of biosimilars in Canada, including changes to the regulation on switching and processes for private plan reimbursement [1].

Clinical data requirements for biosimilars in the EU: efficacy comparability

The European Medicines Agency (EMA) uses a totality of evidence approach in its regulatory review process for biosimilar approval. As part of this, the biosimilar should demonstrate that it does not have clinically meaningful differences from the originator biological, based on comparative clinical studies.

Clinical data requirements for biosimilars in the EU: PK and PD comparability

In their article [1], authors from the Paul-Ehrlich-Institut, the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM), discussed the totality of evidence approach for biosimilars in the European Union (EU) using case studies to illustrate biosimilars for which differences were observed in different parts of the comparability exercise and on the justification for why these differences did not preclude regulatory approval.

Positive real-world data for etanercept biosimilar Benepali

Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) announced on 9 October 2019 that it had presented positive real-world data from its etanercept biosimilar Benepali at the 2019 European Academy of Dermatology and Venereology (EADV) Congress [1].

Clinical data requirements for biosimilars in the EU: analytical comparability

For biosimilars, the regulatory review process is based on the totality of evidence generated in support of biosimilarity.

Trial of bevacizumab copy biological with novel antibody targeting PD-1

China-based Shanghai Henlius Biotech (Henlius) is recruiting patients for a study that will investigate a proposed bevacizumab copy biological in combination with a novel antibody targeting PD-1.

Clinical data requirements for biosimilars in the EU

In their article [1], authors from the Paul-Ehrlich-Institut, the European Medicines Agency (EMA) and the Federal Institute for Drugs and Medical Devices (BfArM) discussed the clinical data requirements for biosimilars in the European Union (EU).

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