Biosimilars
FDA approves pegfilgrastim biosimilar Ziextenzo
Sandoz, the generics division of Novartis, announced on 5 November 2019 that it had received approval from the US Food and Drug Administration (FDA) for its pegfilgrastim biosimilar Ziextenzo (LA-EP2006).
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.
Tanvex BioPharma’s filgrastim biosimilar comes under fire
Taiwan-based biosimilars developer Tanvex BioPharma (Tanvex) is having a rough time lately. In July 2019, Amgen filed an infringement lawsuit against the company regarding its filgrastim biosimilar, TX01. Then in September 2019, US Food and Drug Administration (FDA) rejected Tanvex’s application for approval of TX01.
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.
Bevacizumab ‘similar biologic’ Versavo launched in India
India-based generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) announced on 19 August 2019 that it had launched its bevacizumab ‘similar biologic’, Versavo (DRZ_BZ) in India.
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.
EMA approval for Pegfilgrastim Mundipharma
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 18 October 2019 that it had recommended granting of a marketing authorization for the pegfilgrastim biosimilar Pegfilgrastim Mundipharma.
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.
