Biosimilars

Biosimilar comparability debate continues

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].

Teva receives FDA approval for filgrastim in the US

Teva Pharmaceutical Industries (Teva) announced on 30 August 2012 that FDA had granted approval for tbo-filgrastim (XM02 filgrastim), the first new granulocyte colony-stimulating factor (G-CSF) to be approved in the US in more than 10 years.

Dr Reddy’s plans EU launch for biosimilar rituximab

India-based generics drugmaker Dr Reddy’s Laboratories (Dr Reddy’s) is planning to launch its biosimilar monoclonal antibody Reditux (rituximab) in Europe.

EMA responds to questions over biosimilar comparability

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].

‘Similar biologics’ approved and marketed in India

Last update: 15 February 2018

There have been established guidelines for approving generic versions of small molecule chemical drugs in India for some time already. However, no specific guidelines for ‘similar biologics’, as the Indian regulatory authorities call these products, existed in India until 2012. This has been the case despite the fact that the requirements for granting regulatory approval for such ‘similar biologics’ required more data than for a simple generic drug application [1].

Patients and biosimilar interchangeability

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

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?

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.

Testing for unwanted immunogenicity from biologicals

Immunogenicity caused by biologicals, both originator and biosimilar, is an important issue that was raised by Dr Wadhwa from the National Institute for Biological Standards and Control [1].

Asian companies venture into biosimilars for kidney failure

Malaysia-based Chemical Company of Malaysia Berhad (CCM) wholly-owned subsidiary CCM Duopharma Biotech Berhad and Korea-based biotechnology company PanGen Biotech announced on 19 June 2012 that the companies had entered into an agreement to carry out a clinical trial of biosimilar erythropoietin in Malaysia to treat end stage renal failure patients.