Biosimilars/Research
Is pegfilgrastim superior to filgrastim for the treatment of febrile neutropenia?
A study to compare the cost-efficiency of three different recombinant granulocyte colony-stimulating factors (G-CSFs) for the treatment of chemotherapy-induced febrile neutropenia assumes that they are of comparable efficacy. But how solid is the evidence for this assumption? A study by Professor Matti Aapro and co-authors explores the available evidence regarding efficacy for the three G-CSFs, filgrastim (Neupogen, Amgen), pegfilgrastim (Neulasta, Amgen) and a filgrastim biosimilar (Zarzio, Sandoz/Novartis) and concludes that evidence behind previous claims of superiority for pegfilgrastim is ‘similar’ and ‘open to question’ [1]. Thus, originator and biosimilar filgrastim appear to be holding ground in the efficacy stakes.
Immunogenicity of biologicals
This article discusses the issue of immunogenicity with respect to originator biologicals and biosimilars [1].
Pricing of biosimilars
For small molecule generics, reductions in price of around 80% have been observed after the first six months to a year of generics entry to the market in countries such as Germany, UK and the US [1, 2]. Biosimilars, however, are an entirely different entity.
Factors affecting market access of biosimilars
Growth in the use of biosimilars is being driven by the need to reduce healthcare costs, patent expiries on blockbuster originator biologicals and better-defined regulatory pathways.
Testing for unwanted immunogenicity from biologicals
Immunogenicity caused by biologicals, both originator and biosimilar, is an important issue that was raised by Dr Wadhwa from the National Institute for Biological Standards and Control [1].
Positive results from phase I study with biosimilar insulin glargine
Leading biotech company Biocon announced on 25 July 2012 positive results from a phase I comparative study conducted in Germany of its biosimilar insulin glargine in type 1 diabetes mellitus (T1DM) patients.
Biosimilar infliximab equivalence proven in phase III trial
Results from a phase III trial of biosimilar infliximab have proven the equivalence of South Korean biotechnology company Celltrion’s biosimilar (CT-P13) and the reference product – Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab) in terms of safety and efficacy in patients with active rheumatoid arthritis [1].
Small molecule versus biological drugs
Biological drugs are large and complex, often consisting of heterogeneous mixtures. They are generally made in genetically engineered cells that impose their own variabilities–in post-translation modifications such as glycosylation–on the processes used to make such drugs.
Phase I trial of biosimilar infliximab proves biosimilarity
Results from a phase I trial of biosimilar infliximab have proven the equivalence of South Korean biotechnology company Celltrion’s biosimilar (CT-P13) and the reference product – Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab) in terms of pharmacokinetic parameters, as well as in safety and efficacy in patients with active ankylosing spondylitis [1].
Prescriber caution is likely over biosimilars
The experience with generic medicines is a sign that prescribers are likely to be cautious, and in some cases concerned, about the use of biosimilars as alternatives to brand-name drugs.
