Guidelines

Patients undergoing chemotherapy for cancer can often become anaemic as their red blood cell counts, and hence iron levels, fall. Besides the traditional approach of offering blood transfusion in order to restore iron levels, physicians can now treat patients with drugs that stimulate red blood cell development – known as erythropoiesis-stimulating agents (ESAs). Both treatments can boost iron-containing haemoglobin (Hb) levels, but they also pose risks to the patients. With transfusions, patients are at risk from serious infections and immune-mediated adverse events, while with ESAs; there is an increased risk of thromboembolism and death from other (but poorly understood) causes [1].

EMA announced on 2 May 2013 the publication of its new draft biosimilars guideline, which will revise the agency’s 2005 overarching guideline on similar biological medicinal products. The draft guideline has been released for a six-month consultation period.

The regulatory body for approval of medicines in Argentina is the Administración Nacional de Medicamentos, Alimentos y Tecnología Médica (National Administration of Drugs, Foods and Medical Devices; ANMAT).

FDA announced on 1 April 2013 that it had issued draft guidance for biosimilar meetings outlining standardized procedures for requesting, preparing, scheduling, conducting and documenting such formal meetings with FDA.

Patients undergoing chemotherapy for cancer are at risk of developing the sometimes fatal condition of febrile neutropenia (FN), involving infection, fever and sepsis due to a loss of neutrophils. Prophylaxis with recombinant granulocyte colony-stimulating factor (G-CSF) has been shown to reduce hospital admissions, antibiotic use and the need for chemotherapy dose reduction. Several forms of recombinant G-CSF are available, including filgrastim and its biosimilars, or the pegylated version of filgrastim. All three are considered to be equivalent in terms of clinical efficacy and safety.

Last update: 10 May 2013

The regulatory body for approval of medicines in the EU is EMA. The agency is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the EU.

Last update: 5 April 2013 

The regulatory body for approval of medicines in the US is FDA.

The Colombian Ministry of Health and Social Protection (Ministerio de Salud y Protección Social de Colombia) announced on 21 January 2013 the release of a new draft guideline for biologicals, including biosimilars, in Colombia.

In March 2013, EMA released two guidelines on how pharmaceutical companies should test biosimilar medicines containing interferon beta and recombinant follicle stimulation hormone (r-FSH).

The Egyptian Drug Authority (EDA) announced on 20 January 2013 that a draft guideline for the registration of biosimilars in Egypt had been released by the Central Administration for Pharmaceutical Affairs (CAPA) in coordination with the National Organization for Research & Control of Biologics (NORCB).