Biosimilars/Research

Overview of research on safety and immunogenicity of biosimilars in 2012

Biosimilars/Research | Posted 05/10/2012

Period: January to August 2012

Biosimilars or ‘biosimilar medicinal products’ are medicinal products that are similar (but not identical) in terms of quality, safety and efficacy to an authorised biological reference medicine. Manufacturing of biologicals is complex, and the quality of the resulting biological is dependent on careful control of manufacturing processes and conditions. Unlike traditional small molecule (chemical) drugs, the development of biologicals is different and variable with respect to the manufacturing process and environmental factors, such as light and temperature. The complexity and heterogeneity of the molecular structure, complicated manufacturing processes, different analytical methods and possibility of immunogenicity reactions make quantitative evaluation of biosimilars a challenge to both the scientific community and regulatory agencies.

Boehringer Ingelheim starts biosimilar rituximab trial

Biosimilars/Research | Posted 21/09/2012

Germany-based Boehringer Ingelheim Pharmaceuticals (Boehringer Ingelheim) is starting a Phase III trial for a biosimilar version of rituximab.

Biosimilar comparability debate continues

Biosimilars/Research | Posted 14/09/2012

Authors Schellekens and Moors comment on the response from EMA’s Biosimilar Medicinal Products Working Party to questions that they raised regarding EMA’s comprehensive biosimilar regulatory pathway [1]. While the authors express their appreciation of the openness of EMA in the way it has pioneered the biosimilars pathway in Europe, they still argue that EMA has failed to show the scientific need for biosimilar comparability [2].

EMA responds to questions over biosimilar comparability

Biosimilars/Research | Posted 07/09/2012

EMA has responded to questions regarding its comprehensive biosimilar regulatory pathway. The pathway, which includes the need for new clinical trials and comparability studies that demonstrate quality, efficacy, and safety, has been accused of proving to be a barrier for the development of clinically superior compounds [1].

Patients and biosimilar interchangeability

Biosimilars/Research | Posted 07/09/2012

Biopharmaceuticals or biologicals are complex medicines produced by living cells. Copies of approved biologicals have been introduced recently. Because of their intrinsic complexity such copies are similar but not identical to the reference medicine and are therefore called ‘biosimilars’. Approval of biosimilars requires a full quality analysis including a detailed comparison to the reference whereas non-clinical and clinical evaluations are less extensive.

Investigating G-CSF biosimilars approved in Europe

Biosimilars/Research | Posted 24/08/2012

A life-threatening complication for patients undergoing chemotherapy is febrile neutropenia, involving a loss of neutrophils (white blood cells) and fever. Granulocyte colony-stimulating factors (G-CSFs) are growth factors which are used to restore neutrophil production.

Is pegfilgrastim superior to filgrastim for the treatment of febrile neutropenia?

Biosimilars/Research | Posted 17/08/2012

A study to compare the cost-efficiency of three different recombinant granulocyte colony-stimulating factors (G-CSFs) for the treatment of chemotherapy-induced febrile neutropenia assumes that they are of comparable efficacy. But how solid is the evidence for this assumption? A study by Professor Matti Aapro and co-authors explores the available evidence regarding efficacy for the three G-CSFs, filgrastim (Neupogen, Amgen), pegfilgrastim (Neulasta, Amgen) and a filgrastim biosimilar (Zarzio, Sandoz/Novartis) and concludes that evidence behind previous claims of superiority for pegfilgrastim is ‘similar’ and ‘open to question’ [1]. Thus, originator and biosimilar filgrastim appear to be holding ground in the efficacy stakes.

Immunogenicity of biologicals

Biosimilars/Research | Posted 25/05/2012

This article discusses the issue of immunogenicity with respect to originator biologicals and biosimilars [1].

Pricing of biosimilars

Biosimilars/Research | Posted 23/03/2012

For small molecule generics, reductions in price of around 80% have been observed after the first six months to a year of generics entry to the market in countries such as Germany, UK and the US [1, 2]. Biosimilars, however, are an entirely different entity.

Factors affecting market access of biosimilars

Biosimilars/Research | Posted 03/02/2012

Growth in the use of biosimilars is being driven by the need to reduce healthcare costs, patent expiries on blockbuster originator biologicals and better-defined regulatory pathways.