Biosimilars
Biologicals boom
Researchers predict that the present list of top 10 blockbuster drugs will change dramatically by 2014. The predictions are that by 2014 biological drugs will topple the present market leaders Pfizer’s Lipitor (atorvastatin) and Sanofi’s Plavix (clopidogrel), both of which are small molecule chemical entities [1].
Biotech firms try to limit biosimilar substitution in US
FDA is still to approve a biosimilar and has yet to issue final guidelines outlining the regulatory requirements for approval of a biosimilar in the US.
Assessment of biosimilarity under the BPCI Act
The Biologics Price Competition and Innovation (BPCI) Act defines a biosimilar as a product that is highly similar to the reference product notwithstanding minor differences in clinically inactive components and without clinically meaningful differences in terms of safety, purity, and potency. Although draft guidances issued by FDA do begin to clarify the issue, little or no discussion regarding how similar is considered highly similar is given in the BPCI Act and no criteria for assessing biosimilarity were mentioned [1].
G-CSF biosimilars – World Marrow Donor Association position
The World Marrow Donor Association (WMDA) has expressed its position on the use of granulocyte colony-stimulating factor (G-CSF) biosimilars in healthy donors in an article published in the journal Haematologica [1].
Mobilization of stem cells in healthy donors by G-CSF biosimilars shows comparable efficacy and safety to Neupogen
Originator human recombinant granulocyte colony-stimulating factor (G-CSF) filgrastim has been widely used for the mobilization of CD34+ stem cells in healthy donors. However, there is limited experience with the use of biosimilar G-CSF for the mobilization of peripheral blood stem cells (PBSCs), especially in healthy donors. A recent study by Professor Schmitt and co-authors has addressed this issue and found that biosimilar G-CSF showed comparable efficacy and safety with reference G-CSF (Neupogen) when used for the mobilization of CD34+ stem cells, as well as CD3+ T-cells and nucleated cells, in healthy donors [1].
Top developments in biosimilars during 2012
Much has happened in the biosimilars’ industry over the last year.
Overview of research on G-CSF biosimilars in 2012
Period: January to August 2012
A life-threatening complication for patients undergoing chemotherapy is febrile neutropenia, involving a loss of neutrophils (white blood cells) and fever [1]. Granulocyte colony-stimulating factors (G-CSFs) are growth factors, which stimulate the bone marrow to produce white blood cells and restore neutrophil production. In oncology and haematology, G-CSF is used with certain cancer patients to accelerate recovery from neutropenia after chemotherapy, allowing higher-intensity treatment regimens.
Biosimilarity and interchangeability under the BPCI Act
In the US, the Biologics Price Competition and Innovation (BPCI) Act was signed into law on 23 March 2010, giving FDA the authority to approve biosimilars. FDA then issued guidelines for biosimilar applications in February 2012 in the form of three draft guidance documents [1]. Despite this, there remain scientific issues regarding the assessment biosimilars and the criteria for establishing biosimilarity and interchangeability of biosimilars [2].
Positive phase I data for infliximab biosimilar
US-based Epirus Biopharmaceuticals (Epirus) announced on 4 January 2013 that its biosimilar infliximab candidate had ‘achieved bioequivalence’ to Remicade (infliximab) in a single dose comparator trial.
ProCognia completes global glycoanalysis centre
Israeli biotech company ProCognia announced on 14 January 2013 the completion of its global centre of excellence for glycoanalytics.
