Commentary
Biosimilar monoclonal antibodies approved for use in the EU
Author(s): Meenu Wadhwa, PhD, Robin Thorpe, PhD, FRCPath
Page: 9-10
Abstract: Two biosimilar TNF-alfa monoclonal antibody (mAb) products were approved for clinical use in the European Union on 10 September 2013, following a positive opinion by the Committee for Medicinal… Read More »
Maximizing quality in the manufacture of biologicals
Author(s): Gustavo Grampp, PhD, Sundar Ramanan, PhD
Page: 170-2
Abstract: Biological product quality is susceptible to unexpected manufacturing issues, and the resulting variation may impact the safety or efficacy of these medicines and increase risks to patients. These risks… Read More »
Ongoing initiatives in the Republic of Srpska to enhance prescribing efficiency; influence and future directions
Abstract: Dr Brian Godman reviews the paper by Markovic-Pekovic et al. regarding recent reforms in the Republic of Srpska. These include prescribing restrictions where concerns with the value of products… Read More »
Biosimilar monoclonal antibodies—challenges and opportunities in Europe
Abstract: New regulations for the development of biosimilars have been introduced in Europe and a new class of biosimilars – monoclonal antibodies – is expected on the market soon, which… Read More »
Commentary on the recommendations of the European Society for Organ Transplantation Advisory Committee on generic substitution of immunosuppressive drugs
Author(s): Professor Teun van Gelder, MD, PhD
Page: 108-9
Abstract: In 2010, the Council of the European Society for Organ Transplantation formed an Advisory Committee to formulate recommendations on the use of generic drugs in solid organ transplant recipients.… Read More »
The case for biosimilars–a payer’s perspective
Abstract: Biosimilars have the potential for making savings in healthcare costs, and with resource allocation, if competition is permitted at the level of treatment induction. Submitted: 24 August 2012; Revised: 17 January 2013; Accepted: 4… Read More »
Pharmacovigilance of biosimilars: challenges and possible solutions
Author(s): Sabine MJM Straus, MD, PhD, Thijs J Giezen, PharmD, PhD, MSc
Page: 118-9
Author byline as per print journal: Thijs J Giezen, PharmD, PhD; Sabine MJM Straus, MD, PhD Abstract: Post-marketing surveillance is essential to detect, assess and prevent adverse reactions of chemically synthesized small… Read More »
Statin generics: no differences in efficacy after switching
Abstract: A study presented at the 2010 Congress of the European Society of Cardiology, had created a considerable stir. Its abstract allegedly showed that the originator drug Lipitor was more… Read More »
Innovator companies should focus on innovations
Abstract: Despite biopharmaceuticals having an enormous potential value for our health, they have also become a serious threat to our healthcare systems. Submitted: 22 June 2011; Revised manuscript received: 6… Read More »
The biosimilar name debate: what’s at stake for public health
Author(s): Emily A Alexander, JD
Page: 10-2
Abstract: As the number of innovator biologics and biosimilars increases worldwide, a growing debate has focused on how these products should be named. The simple concept of a name can… Read More »