Biosimilars/Research

Positive results from phase I study with biosimilar insulin glargine

Biosimilars/Research | Posted 03/08/2012

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

Biosimilars/Research | Posted 06/07/2012

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

Biosimilars/Research | Posted 29/06/2012

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

Biosimilars/Research | Posted 29/06/2012

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

Biosimilars/Research | Posted 01/06/2012

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.

Biosimilar filgrastim provides cost savings for treating febrile neutropenia

Biosimilars/Research | Posted 11/05/2012

Professor Aapro and co-authors have performed a cost-efficiency analysis for the three most common granulocyte colony-stimulating factors (G-CSF) products used to treat febrile neutropenia: filgrastim (Neupogen, Amgen) and its biosimilar (Zarzio, Sandoz/Novartis) and the pegylated form of filgrastim, pegfilgrastim (Neulasta, Amgen) [1]. Filgrastim is more cost-efficient than pegfilgrastim for up to 12 days of treatment: beyond 12 days, pegfilgrastim becomes the most cost-efficient of the two. But above all, biosimilar filgrastim is the most cost saving compared to both originator filgrastim and pegfilgrastim.

Bioavailability comparison of brand-name and generic acetylcysteine in China

Biosimilars/Research | Posted 04/05/2012

A study comparing brand-name and generic acetylcysteine in China by Liu et al has shown that the generics test formulation was bioequivalent to the originator drug [1].

Oncologists urged to embrace biosimilars to help control spiraling costs of cancer care

Biosimilars/Research | Posted 24/02/2012

Oncologists have been urged to embrace biosimilar drug substitution to help control the spiraling costs of cancer care. However, they have been warned that the optimal realisation of such a programme requires successful educational initiatives and the development of effective working partnerships with pharmacists and patients [1].

The controversies surrounding biosimilars

Biosimilars/Research | Posted 10/11/2011

It is well known that the introduction of similar biological medicinal products, or biosimilars, has caused not a little controversy in the medical world. The aim of healthcare providers/payers, either healthcare authorities or insurance companies, is to reduce the healthcare budget has risen in recent years through the introduction of expensive companion diagnostics, devices, and drugs. At the present moment this can only be achieved in two general ways: either the availability of therapies must be restricted from the patients who would benefit from them, or otherwise the costs of the procedures and drugs must be reduced to within affordable limits so that the majority of patients can benefit from them.

Study of biosimilar enoxaparins in Brazil

Biosimilars/Research | Posted 27/04/2012

Analysis of biosimilar enoxaparins available for clinical use in Brazil by the Laboratório de Tecido Conjuntivo in Brazil have shown that the biosimilar preparations of enoxaprain are similar to the originator drug [1].