Biosimilars/Research
Use of G-CSF biosimilars for stem cell mobilization in autologous transplantation
The first biosimilar granulocyte colony-stimulating factor (G-CSF) was licensed by EMA in 2008, and there are currently six biosimilar G-CSF products licensed for use in the EU [1]. All of these biosimilars are also approved for haematopoietic stem cell transplantation.
Biopharmaceutical products in Iran
Iran will become a leader in biotechnology products (especially copied biopharmaceuticals [1]) in Asia over the next three years, according to a review by Mahboudi et al. [2].
Use of G-CSF biosimilars for stem cell mobilization in healthy donors
Granulocyte colony-stimulating factor (G-CSF) can be used to mobilize peripheral blood stem cells (PBSCs) in healthy donors. Over the last 10 years, the procedure has become the preferred option for donors compared to the donation of bone marrow.
Saving money in the European healthcare system with biosimilars
Biotechnology-derived medicines are increasingly popular for treating a range of conditions from cancer to autoimmunity, and yet they are among the most expensive healthcare products owing to their manufacture using live cell cultures. As healthcare providers become increasingly concerned about rising costs, interest is turning to the idea of substituting reference biological drugs with cheaper but similar biological products, or biosimilars, after patents expire on reference products. The use of biosimilars has the potential to reduce healthcare expenditure, particularly for long-term treatments, which incur high annual treatment costs.
Development of biosimilars for rheumatology
In 2012, worldwide sales for the top three selling tumour necrosis factor (TNF) inhibitors reached US$20 billion. These biological treatments for arthritis are costing patients between US$10,000–US$30,000 per year making the need for lower cost biosimilars clear [1].
Research on clinical trial issues for biosimilars
Period: September to December 2012
In order to demonstrate comparability between a biosimilar and its reference product, EMA recommends that the clinical trial should make it possible to detect a difference between the biosimilar and reference product. In most cases, this means that a two-arm clinical trial design (reference biological and biosimilar) in a small group of homogenous patients may be used. If the two arms of the trial produce similar results, then the biosimilar can be approved.
Quality, similarity and safety of biosimilars
An abbreviated pathway for the approval of biosimilars was implemented in the EU in 2005. Despite biosimilars being available in Europe for more than seven years, physicians still have concerns about the use of biosimilars. Members and experts of the Working Party on Similar Biologic Medicinal Products of the European Medicines Agency (EMA) highlight what physicians need to know to make informed and appropriate treatment choices for their patients [1].
Phase I/IIb trial of CT-P6 shows comparability to trastuzumab
Results of a phase I/IIb trial for South Korean biotechnology company Celltrion’s biosimilar candidate CT‑P6 were presented at the 13th St Gallen International Breast Cancer Conference held in St Gallen, Switzerland, on 13–16 March 2013. The results demonstrated the comparable pharmacokinetics and safety of CT-P6 to the reference drug.
Research on biosimilars in anaemia and diabetes
Period: September to December 2012
The use of biological medicines has been life-changing for many patients suffering with anaemia and diabetes. With the expiration of patents on these biologicals the possibility of patients gaining access to lower cost biosimilar alternatives to these extremely effective, but costly, medicines becomes a real possibility.
Biosimilars in rheumatology
Patents on key biological medicines used in rheumatology will expire soon. The European Medicines Agency’s (EMA’s) finalized guidelines on biosimilar monoclonal antibodies (mAbs) came into effect on 1 December 2012. Both of these facts mean that rheumatologists can expect to be exposed to biosimilars of the medicines they routinely use in the near future.
