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Brazilian guidelines for biosimilars

Published on 2012/08/15

The regulatory body for approval of medicines in Brazil is the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, Anvisa), which was created by Law 9782, enacted in 199...

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Prescriber caution is likely over biosimilars

Published on 2012/08/13

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-named drugs. Generic med...

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Amgen welcomes biosimilar monoclonal antibody guideline

Published on 2012/08/09

In a statement issued on 18 June 2012, biologicals major Amgen announced that the company broadly supports the scientific principles behind the guideline on non-clinical and clinical aspects for biosi...

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Trials of biosimilar monoclonal antibody prove biosimilarity

Published on 2012/07/06

South Korean biotechnology company Celltrion presented the PLANET clinical studies results of phase I and phase III trials for its first monoclonal antibody biosimilar (CT-P13) of Johnson & Johnso...

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EMA finalises biosimilar monoclonal antibody guidelines

Published on 2012/07/04

EMA announced on 15 June 2012 that it had finalised two guidance documents describing how pharmaceutical companies should develop biosimilar monoclonal antibodies. The guidelines set out how developer...

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Mylan moving ahead

Published on 2012/07/02

Three announcements in three days, in four different countries―Mylan is continuing to make progress in generics. Launch of generic lamivudine in Italy and UKOn 6 June 2012, Mylan announced that its...

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Immunogenicity of biologicals

Published on 2012/06/29

This article discusses the issue of immunogenicity with respect to originator biologicals and biosimilars. Biotechnology derived products such as coagulation factors, cytokines, enzymes, fusion prote...

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FDA’s public hearing on biosimilars draft guidances

Published on 2012/06/27

On 11 May 2012, FDA held a public hearing to gain input on their draft guidances relating to the development of biosimilar products and it seems that the guidances were generally well accepted. FDA i...

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Biosimilars approved and marketed in Belgium

Published on 2012/06/25

The Federal Agency for Medicines and Health Products (FAMHP), formerly the Directorate-General for Medicinal Products of the Federal Public Service (FPS) Public Health, created in January 2007, is the...

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Biosimilars marketed in Europe

Published on 2012/06/22

Europe was the first region to approve and introduce biosimilars into the market back in 2006, and now in 2012 the continent is the largest biosimilars market in the world, with 14 biosimilars approve...

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Biosimilar filgrastim provides cost savings for treating febrile neutropenia

Published on 2012/06/20

Dr 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 (Neupo...

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Comparison of brand-name and biosimilar etanercept in Korea

Published on 2012/06/18

A study comparing pharmacokinetics and tolerability of branded etanercept (25 mg) and its biosimilar (25 mg) in Korea reported by Gu et al has shown that the reference drug and the test biosimilar met...

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