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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].

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.

Screening protein surface biosimilarity of rituximab using aptamers

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.

More positive phase III results for rituximab biosimilar ABP 798

Biotech giant Amgen, and its partner Allergan, announced on 22 August 2019 positive data from a ‘top-line’ phase III study of its rituximab biosimilar (ABP 798) compared to Rituxan (rituximab) in non-Hodgkin's lymphoma (NHL) patients.

Clinical comparability between rituximab biosimilar RTXM83 and rituximab in diffuse large B-cell lymphoma patients

The arrival of biosimilars represents more affordable alternatives for patients in several countries, increasing their access to costly biological treatments [1]. The positive impact of biosimilars on the financial sustainability of healthcare systems has been recognized by several haemato-oncological societies.