Biosimilars/Research

Strategy for biosimilars in China

Biosimilars/Research | Posted 26/09/2014

China is one of the largest pharmaceutical markets in the world, and has seen rapid growth in the biopharmaceuticals industry in recent years. However, it is still lacking guidance when it comes to biosimilars. Authors Li and Tuan from the Shenyang Pharmaceutical University, China, discuss how this affects biologicals companies in China [1].

Biosimilar etanercept demonstrates equivalent efficacy

Biosimilars/Research | Posted 04/07/2014

A phase III trial comparing Hanwha Chemical Corporation (Hanwha)’s biosimilar etanercept, HD203, with Enbrel (etanercept) has demonstrated equivalent efficacy [1].

Adalimumab biosimilar has comparable pharmacokinetics to Humira

Biosimilars/Research | Posted 05/09/2014

An adalimumab biosimilar (CHS-1420) from fledgling biotech company Coherus Biosciences (Coherus) has shown comparable pharmacokinetics in a pivotal clinical study.

The future of biosimilar use and regulation in Latin America

Biosimilars/Research | Posted 29/08/2014

There is a growing uptake of biosimilars in Latin America, but this has not been accompanied by an increase in pharmacovigilance, training or regulation. To address this, an expert panel was put together to discuss the issues involved. The panel’s perspectives on the current status led to six major recommendations drawn up to enhance the safe use of biosimilars across the region [1].

ECCO survey highlights lack of confidence in biosimilar mAbs

Biosimilars/Research | Posted 22/08/2014

In a presentation at the EuropaBio and the Alliance for Safe Biologic Medicines (ASBM) roundtable on naming, transparency and traceability for biosimilars [1], held on 18 March 2014 in Brussels, Belgium, Dr Alessandro Armuzzi presented results of a survey of European Crohn’s and Colitis Organisation (ECCO) members [2]. The results of the survey highlight the lack of confidence ECCO members have in biosimilars and the need for continued education.

Biosimilars in the treatment of chemotherapy-induced anaemia

Biosimilars/Research | Posted 14/08/2014

A study of the use of epoetin biosimilars in the therapeutic management of anaemia secondary to chemotherapy in haematology and oncology has shown the biosimilars to be effective and well tolerated in the management of chemotherapy-induced anaemia in patients with solid tumours, lymphoma and myeloma [1].

Biosimilar trastuzumab similar to Herceptin in non-clinical study

Biosimilars/Research | Posted 08/08/2014

Comparative non-clinical assessments of the proposed trastuzumab biosimilar PF-05280014 and the originator product (Herceptin) sourced in the US and in Europe showed similar structural properties, tumour cell growth inhibition properties and pharmacokinetic profiles, as well as safety profiles [1].

Phase I studies of infliximab and rituximab biosimilars demonstrate pharmacokinetic similarity

Biosimilars/Research | Posted 01/08/2014

Results of phase I trials of pharma giant Pfizer’s biosimilar infliximab and rituximab candidates have demonstrated similar pharmacokinetic properties compared to the originator products [1, 2].

Biosimilar infliximab comparable to Remicade

Biosimilars/Research | Posted 27/06/2014

Results from a phase III trial have demonstrated the comparability of US-based Epirus Biopharmaceuticals (Epirus) biosimilar (BOW015) to Remicade for the treatment of rheumatoid arthritis.

Can the pursuit of biosimilar interchangeability go too far?

Biosimilars/Research | Posted 20/06/2014

The question of biosimilar interchangeability – whether or not a biosimilar can safely be switched with another biosimilar or with the originator product – is a thorny one. In fact, write Hans C Ebbers and Paul Chamberlain [1], striving for some of the standards suggested to certify interchangeability may not be in a patient’s best interests.