Guidelines
EMA issues draft concept paper on comparing quality in biologicals and biosimilars
On 28 June 2013, the European Medicines Agency (EMA) released a draft concept paper to discuss the issue of how to compare the quality attributes for biological products and biosimilars. The draft concept paper has been released for a three-month consultation period.
Revision of guideline on clinical and non-clinical issues for biosimilars
On 10 June 2013, EMA released a revision of the guideline addressing the clinical and non-clinical issues related to similar biological products (biosimilars) containing biotechnology-derived proteins as the active substance. The draft guideline has been released for a six-month consultation period.
EMA issues draft revision of overarching biosimilar guidelines
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.
FDA issues draft guidance for biosimilar meetings
FDA announced on 1 April 2013 that it had issued draft guidance for biosimilar meetings outlining standardized procedures for requesting, preparing, scheduling, conducting and documenting such formal meetings with FDA.
Guideline update on prevention of febrile neutropenia with G-CSF
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.
EMA releases guidelines on biosimilar interferon beta and r-FSH
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).
Egypt issues draft guidelines for biosimilars
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).
Draft revision of biosimilar low molecular weight heparin guideline
EMA announced on 31 January 2013 that it had released a draft guideline to revise the agency’s current guideline on biosimilars containing low molecular weight heparins (LMWHs). The draft guideline will be released for a six-month public consultation period.
China’s SFDA to fast-track high-priority generics
China’s State Food and Drug Administration (SFDA) has set out a number of proposed changes to the drug registration process, providing encouragement for domestic innovation and allowing the fast-track review of generic drugs which answer an unmet clinical need.
EMA publishes draft guideline for biosimilar human insulin
EMA announced on 14 December 2012 that it had published a draft guideline revising its current guideline on the non-clinical and clinical development of biosimilar human insulin and insulin analogues. The draft guideline will be released for a six-month public consultation period.
