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

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

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

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

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

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

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.

Biocomparable has comparable safety and efficacy to originator erythropoietin in haemodialysis patients

A study of the treatment of patients with chronic kidney disease undergoing haemodialysis with ‘biocomparable’ and originator erythropoietin in Mexico has shown comparable efficacy and safety in terms of changes in haemoglobin levels [1].

Extrapolation of indications in biosimilars: infliximab

Physicians may not be well informed about the scientific concept underlying the principle of extrapolating* indications for biosimilars. This in turn may lead them to distrust biosimilars, leading to a lower than expected uptake in Europe, especially in extrapolated indications. Members of the European Medicines Agency’s (EMA) Working Party on Similar Biological (Biosimilar) Medicinal Products (BMWP) address these concerns using extrapolation of indications in biosimilar infliximab as an example [1].

Phase I study shows darbepoetin alfa biosimilar to be well tolerated

Chong Kun Dang Pharmaceutical (CKD Pharma) announced on 18 November 2014 the successful completion of its phase I pharmacokinetics study for its biosimilar darbepoetin alfa product.

Extrapolation of indications in biosimilars: epoetin

Despite a stringent approval process, acceptance of biosimilars in the medical community continues to be low, and especially in extrapolated* indications. Members of the European Medicines Agency's (EMA) Biosimilar Medicinal Products Working Party (BMWP) address these concerns using extrapolation of indications in biosimilar epoetin as an example [1].

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