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ECCO survey highlights lack of confidence in biosimilar mAbs

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

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].

Switching and extrapolation of subsequent entry biologics in Canada

The regulatory framework for biosimilars in Canada explains how their substitutability and/or interchangeability are governed in the country. Biosimilars, which are known as subsequent entry biologics (SEBs) in Canada, are regulated in line with guidance from the World Health Organization.

Biosimilar trastuzumab similar to Herceptin in non-clinical study

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

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

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?

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.

Synthon’s SYD985 outperforms Kadcyla in vitro and in vivo

Synthon announced on 2 April 2014 that its antibody-drug conjugate SYD985 had outperformed Roche’s breast cancer blockbuster Kadcyla (trastuzumab emtansine) in a head-to-head comparison.

Biosimilar epoetin shows good safety profile in post-authorization study

US-based generics manufacturer Hospira announced on 28 April 2014 positive results from a post-authorization observational safety study of its biosimilar epoetin product Retacrit/Silapo (epoetin zeta) in patients with renal anaemia [1].

Biosimilars for inflammatory bowel disease in Norway

Europe approved its first biosimilar monoclonal antibody Inflectra/Remsima (infliximab) on 10 September 2013 [1]. The biosimilar is now recommended by the Norwegian Drug Procurement Cooperation (LIS) as the first choice, which carries out the procurement for all medicines financed by public hospitals in Norway. Gastroenterologists, however, are cautious about using the biosimilar ‘until more studies of the new medicine have been completed’ [2].

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