Attitudes and beliefs are powerful influences on generics use

2012-08-20 While generic drugs have the potential to provide significant savings in healthcare costs, and numerous financial incentives are in place, the generics substitution rate in… Read More »

Merck KGaA and Dr Reddy’s to collaborate on biosimilar mAbs

2012-08-17 Pharma major Merck KGaA announced on 6 June 2012 its first steps into the biosimilars market, with an agreement with India-based generics manufacturer Dr Reddy’s… Read More »

Brazilian guidelines for biosimilars

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… Read More »

Prescriber caution is likely over biosimilars

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… Read More »

Amgen welcomes biosimilar monoclonal antibody guideline

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… Read More »

Trials of biosimilar monoclonal antibody prove biosimilarity

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)… Read More »

EMA finalises biosimilar monoclonal antibody guidelines

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… Read More »

Mylan moving ahead

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… Read More »

Immunogenicity of biologicals

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 proteins,… Read More »

FDA’s public hearing on biosimilars draft guidances

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… Read More »

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