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Pivotal clinical trials for adalimumab biosimilars

Biosimilars of AbbVie’s Humira (adalimumab), a human monoclonal antibody, are currently under development.

Clinical programmes for oncology biosimilars

Biosimilars for oncology drugs are currently under development. These include biosimilars of blockbusters such as Roche’s Avastin (bevacizumab), MabThera/Rituxan (rituximab) and Herceptin (trastuzumab).

Doctors’ survey reveals lack of confidence in biosimilars

Online physician’s platform and community QuantiaMD survey of 300 primary care physicians and specialists in the US has found a lack of confidence concerning biosimilars. 

Clinical programmes for anti-TNF biosimilars

Biosimilars for anti-tumour necrosis factor (anti-TNF) drugs are currently under development. These include biosimilars of blockbusters such as AbbVie’s Humira (adalimumab), Amgen’s Enbrel (etanercept) and Johnson & Johnson’s Remicade (infliximab).

Cost reductions due to biosimilars in Europe

Biosimilars have been approved in the European Union since 2006 in the classes of erythropoietin (EPO), human growth hormone (HGH), granulocyte colony-stimulating factor (G-CSF) and anti-tumour necrosis factor (anti-TNF).  Despite the fact that they have been in use since 2006, the prices for EPO, HGH and G-CSF classes of drugs in some countries have not reduced by as much as some might have expected. There is also a significant variation between different countries in Europe [1].

Biosimilars penetration in Europe varies widely

The penetration of biosimilars in Europe varies widely between countries and therapy areas [1].

Generics prices in US decrease again in 2013

In 2013, retail prices for 280 widely used generics fell by an average of 4.0%, compared to the US inflation rate, which was 1.5% over the same period.

Biosimilar events from 2013 to 2015

During the period of 2013 to 2015, biosimilars has been increasingly on the agenda around the world.  Biosimilars are making steady progress, as can be seen by the increasing number of events, including approvals for biosimilars around the world [1].

UK patient groups say pharma needs to reduce cost of medicines

A report produced by patient research organization PatientView has found that UK patient groups think that the pharma industry could be doing a lot more for patients.

FDA making progress but still needs to conduct more inspections

A report from the US Office of the Inspector General (OIG) published in May 2015 has found that although the US Food and Drug Administration (FDA) has made progress on the oversight and inspection of manufacturers of generics, it still needs to conduct outstanding pre-approval inspections of generics makers, which could lead to more timely approval of these drugs.

Generics News Research General


Biosimilars News Research General