Biosimilars/Research

Pricing of biosimilars

Biosimilars/Research | Posted 23/03/2012

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

Biosimilars/Research | Posted 03/02/2012

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

Biosimilars/Research | Posted 10/08/2012

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

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].