More Articles

Will the EU biosimilars pathway be applicable to monoclonal antibodies? Biosimilars/Research | Posted 08/03/2010

To what extent is the existing framework for biosimilars in Europe likely to be applicable to monoclonal antibodies (mAbs)? This question was verified in a paper by Dr Christian Schneider –member o...

A follow-on biologic drug is not a ‘biogeneric’: Lessons from Omnitrope and Valtropin Biosimilars/Research | Posted 08/03/2010

In an article by Dr Robert Roth and Dr Nicholas Fleischer of the Weinberg Group published in Journal of Generic Medicines of May 2009, it is stated that a follow-on biologic drug is not a ‘biogener...

FirstWord report: Branded versus generic drugs in Latin America Reports | Posted 08/03/2010

In the FirstWord report Branded vs. Generic Drugs in Latin America published in February 2010, it is stated that on every border, across every frontier of Latin America, a revolution is underway. P...

PhRMA, Amgen correct NEJM article on biologics exclusivity Biosimilars/Research | Posted 05/03/2010

In a NEJM Letter to the Editor of 18 February 2010, Mr David Wheadon, Senior Vice President of the Scientific & Regulatory Affairs team of the Pharmaceutical Research and Manufacturers of Ameri...

FDA approves Amgen’s and Johnson & Johnson's the risk evaluation and mitigation strategy (REMS) for erythropoiesis-stimulating agents (ESAs) Biosimilars/News | Posted 05/03/2010

Amgen and Johnson & Johnson (J&J) announced on 16 February 2010 that the US FDA approved the companies' risk management strategy for patients with chemotherapy-induced anaemia who are recei...

Improving effector functions of MAbs for cancer treatment: Enhancing antibody-dependent cell-mediated cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) Biosimilars/Research | Posted 04/03/2010

Mr Akito Natsume et al. of Kyowa Hakko Kirin, Machida-shi, Tokyo, Japan, have shown to improve effector functions of monoclonal antibodies (MAbs) for cancer treatment by enhancing ADCC and CDC, as...

Aglycosylated IgG mAbs can be engineered to display unique FcγR selectivity that mediate antibody dependent cell-mediated cytotoxicity Biosimilars/News | Posted 04/03/2010

Until recently, bacterially derived monoclonal antibodies (mAbs) were unable to recruit innate immune cells and were thus ineffective at raising an attack against tumour cells. However, Mr George G...

Pharmacokinetics, bioequivalence of cyclobenzaprine tablets Conferences | Posted 04/03/2010

Cyclobenzaprine is a muscle relaxant, structurally related to first-generation tricyclic antidepressants. At the 2008 World Congress of Pharmacy and Pharmaceutical Sciences held 29 August – 4 Septe...