Acceptable changes in quality for glycosylated biologicals

Biosimilars/Research | Posted 06/05/2011

Research carried out by Sandoz into three glycosylated protein biotechnology drugs currently on the market showed quality changes over the period studied. Since all three drugs remained on the market with unchanged labels, this would indicate that the changes were accepted by the health authorities [1].

Etanercept and quality attributes changes

Biosimilars/Research | Posted 27/05/2011

Quality changes in commercially available etanercept (Enbrel) were found by Sandoz researchers over a period of time. Since the drug remained on the market with an unchanged label, this would indicate that the changes were accepted by the health authorities [1].

Comparison of US and European biosimilar regulatory pathways

Biosimilars/Research | Posted 15/04/2011

The EU and the US have some differences in the way they approach biosimilars. Some of these differences were outlined in an article by Mr David Rosen and Mr Larry Lian published on 2 March 2011.

Pharmacodynamic response of biosimilar filgrastim

Biosimilars/Research | Posted 22/04/2011

Research published online on 10 March 2011 on the pharmacodynamic response of recombinant human granulocyte colony-stimulating factor (G-CSF) filgrastim has shown that there is no difference between biosimilar and originator G-CSF.

Biosimilar low molecular weight heparins in Brazil

Biosimilars/Research | Posted 15/04/2011

In Brazil, the registration of new drugs is carried out only when the regulatory agency (Agência Nacional de Vigilância Sanitária, Anvisa) is fully satisfied with their quality, efficacy and safety. Likewise for biosimilars it is necessary that the biosimilar be equally effective and safe and without contaminants in relation to the originator medicine.

Ongoing monitoring of biosimilar G-CSF (filgrastim)

Biosimilars/Research | Posted 25/03/2011

Sandoz is carrying out ongoing studies to ensure the safety of its biosimilar recombinant human granulocyte colony-stimulating factor (filgrastim G-CSF). The MONITOR-GCSF study will recruit at least 1,000 patients from a minimum of 75 centres and follow them for a maximum of six cycles of chemotherapy.

Biosimilar substitution in the EU

Biosimilars/Research | Posted 04/03/2011

Although many things—including regulations for licensing of biosimilars—are harmonised within the EU, the attitude towards biosimilars and their substitution within the different countries of the EU varies widely.

The case for health economic studies on biopharmaceuticals

Biosimilars/Research | Posted 26/11/2010

In the not too distant future, patents will expire on some major biopharmaceuticals, such as interferons, insulins and granulocyte-colony stimulating factors [1]. This is likely to lead to the market entry of a number of biosimilars. A health economic approach to market access for biopharmaceuticals and biosimilars serves to aid researchers and decision makers in pharmaceutical companies and government to identify those products in the development process that are likely to be safe, effective and cost-effective. This approach should also guide the rationale for registration, pricing and reimbursement decisions.

Biopharmaceuticals: the start of personalised medicine

Biosimilars/Research | Posted 26/11/2010

Biopharmaceuticals typically bind to their biological target, e.g. a protein linked to a disease [1]. Therefore, a biopharmaceutical is likely to be particularly efficacious in a specific subgroup of the patient population. For instance, trastuzumab is a monoclonal antibody that binds to the human epidermal growth factor receptor 2 (HER2) protein and has been shown to be efficacious in the treatment of patients with metastatic breast cancer whose tumours over-express HER2 [2]. This has implications for the clinical development of biopharmaceuticals in that it highlights the need to select the most responsive target population, to collect information on relevant patient characteristics, and to identify suitable biomarkers for responders [3]. It could be argued that, in this respect, biopharmaceuticals involve a paradigm shift towards personalised medicine.

Health economic challenges for biosimilars

Biosimilars/Research | Posted 26/11/2010

Biopharmaceuticals represent a fast-growing segment of the pharmaceutical market, making up one third of products in the development pipeline and accounting for 9% of pharmaceutical expenditure [1]. Whereas the first generation of biopharmaceuticals tended to consist of first-in-class products addressing unmet clinical needs in small populations, e.g. bevacizumab for metastatic colorectal cancer, the current wave of products targets larger populations, e.g. insulins for type 2 diabetes mellitus [2].