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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).

Adalimumab copy biological shown to be safe and effective

Chinese biopharmaceutical firm Innovent Biologics’ adalimumab copy biological has shown comparable safety and efficacy to the originator drug, Humira (adalimumab), in patients with ankylosing spondylitis.

Biosimilars applications reviewed in the EU

The European Union (EU) was the first to establish a legal framework for biosimilars back in 2003 [1]. Since the European Medicines Agency (EMA) approved its first biosimilars in 2006, the agency has issued new guidelines and updated its existing guidelines based on new evidence and rapid advances in analytical sciences [2].

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