Biosimilars/Research

Generics and off-patent biologicals for cancer treatment in developing countries

Biosimilars/Research | Posted 20/02/2015

The understandable focus on infectious diseases, such as human immunodeficiency virus (HIV), malaria and tuberculosis (TB), has meant that an increasing burden of non-communicable diseases (NCDs), notably cancer, now needs urgent attention across developing countries [1]. Generics and biosimilars offer a lower-cost approach to treatment, but these drugs raise challenges of their own.

Positive phase III data for Amgen adalimumab biosimilar

Biosimilars/Research | Posted 20/02/2015

US biopharmaceutical giant Amgen announced on 3 February 2015 positive results from its phase III clinical trial for a biosimilar version of adalimumab in patients suffering from rheumatoid arthritis.

Biosimilars compared to generics in the European market

Biosimilars/Research | Posted 13/02/2015

Once a patent expires, price competition is possible since any manufacturer can copy the originator product. This circumstance justifies the place in the pharmaceutical market for generics and biosimilars, i.e. off-patent medicines to be sold at lower prices than their originators [1].

Impact of nephrology subsequent entry biologics in Canada

Biosimilars/Research | Posted 06/02/2015

Subsequent entry biologics (SEBs) may soon be a reality in Canadian nephrology practice. Along with opportunities to reduce healthcare costs, these agents pose unique challenges to successful implementation. Understanding the experiences around the globe in both regulatory affairs and implementation will be a valuable guide for Canadian clinicians. This review should assist clinicians and policymakers to navigate this complex subject and to make informed decisions in the best interest of their patients [1].

No relevant difference in ADRs from biosimilars and originators

Biosimilars/Research | Posted 30/01/2015

A study of adverse drug reactions reported in Italy has shown no difference between the number and type of side effects reported for biosimilars and their corresponding originators [1].

Filgrastim biosimilar has similar safety and efficacy to Neupogen

Biosimilars/Research | Posted 23/01/2015

A filgrastim biosimilar (EP2006) from Sandoz, the generics division of Swiss pharma giant Novartis, has shown similar safety and efficacy compared to Amgen’s Neupogen (filgrastim) in a pivotal phase III clinical study.

Improved labelling sought for biosimilar acceptance

Biosimilars/Research | Posted 31/10/2014

The terms of approval for every biosimilar and its reference product must be made clearer, argue the European Biopharmaceutical Enterprises (EBE) [1]. The development of biosimilar regulatory pathways worldwide has been led by the European Medicines Agency (EMA) [2], but EMA’s information-driven stepwise approach is only reflected in a single section of the product labelling for healthcare professionals and patients, which so far has followed a generic approach in Europe.