Biosimilars

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.

iBio and GE Healthcare form new global alliance

Biotechnology company iBio, self-professed leader in the plant-made pharmaceutical field, and GE Healthcare, the health business of General Electric, announced on 26 July 2012 a new global alliance to commercialise plant-based technologies for the manufacture of biologicals and vaccines.

FDA urged to exclude plasma protein therapies from biosimilar pathway

FDA is being lobbied by patient and industry groups to exclude plasma protein therapies from its pathway for the approval of biosimilars. FDA has a mandate to create a new abbreviated process for the approval of biosimilars under the Biologics Price Competition and Innovation Act of 2009, which was part of the new healthcare reform law passed in March 2010 [1]. This potentially brings cheaper products to market sooner, and so increases the availability of affordable health care. However, it also means that manufacturers applying for approval for new biosimilars may be able to skip clinical testing if they can demonstrate sufficient similarity with reference products.