Biosimilars/Research
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).
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].
Switching from originator to biosimilar epoetins appears to be effective and safe
Switching between biological drugs during pharmacological treatment leads prescribers and patients to ask themselves the question: ‘Will it be safe?’. In particular, when switching from an originator to a biosimilar, the belief that this choice is shaped by economic reasons feeds suspicions and controversies.
Switching from originator infliximab to CT-P13: real-world data with 24 months of follow up
A prospective observational study with moderate-to-severe Crohn’s disease (CD) and ulcerative colitis (UC) patients switched from infliximab to CT-P13 treatment was carried out at Hospital Universitario Virgen Macarena, Seville, Spain, and reviewed up to 24 months. The primary endpoint was to analyse the loss of response to infliximab after switching. A loss of response was considered as the Harvey–Bradshaw (HB) index >4 for CD, partial Mayo score (PMS) >2 for UC, steroid use or surgery related to the activity of the disease and/or infliximab dose increase during the follow up.
