Biosimilars/Research

Clinical data requirements for biosimilars in the EU: efficacy comparability

Biosimilars/Research | Posted 08/11/2019

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

Biosimilars/Research | Posted 25/10/2019

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

Biosimilars/Research | Posted 25/10/2019

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

Biosimilars/Research | Posted 18/10/2019

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

Biosimilars/Research | Posted 18/10/2019

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

Biosimilars/Research | Posted 11/10/2019

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

Biosimilars/Research | Posted 04/10/2019

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

Biosimilars/Research | Posted 04/10/2019

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

Biosimilars/Research | Posted 27/09/2019

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.

Screening protein surface biosimilarity of rituximab using aptamers

Biosimilars/Research | Posted 20/09/2019

Among the many features needed to prove sufficient biosimilarity to a licensed drug produced in living organisms, is coherency of the three-dimensional structure. The integrity thereof is vital for the efficacy and safety of a biopharmaceutical, and even small and local structural changes may result in loss of function or cause undesired side effects for the patients. Reliable assessment of the detailed three-dimensional structure, however, requires laborious analytical methods like Nuclear Magnetic Resonance (NMR) or X-ray crystallography. Another option, epitope characterization using antibodies specific for the target biologicals, is restricted by the availability of appropriate, well-characterized antibody panels and typically involves animal experiments.