News
New Zealand guidelines for biosimilars
2014-09-04 The regulatory body for approval of medicines in New Zealand is the New Zealand Medicines and Medical Devices Safety Authority (Medsafe). The agency is responsible… Read More »
FDA’s labelling proposal will increase cost of generics
2014-08-14 In November 2013 the US Food and Drug Administration (FDA) proposed a new rule which would allow generics makers to change their labelling in the… Read More »
Generics save US 1.2 trillion over last 10 years
2014-07-29 Generics have saved consumers and the US healthcare system US$217 billion in 2012 and have saved the US in excess of US$1.2 trillion between 2003… Read More »
Guiding principles for biosimilars development
2014-07-21 In contrast to chemically synthesized small-molecule drugs, biologicals have complex structures of high molecular weight. Therefore, even small changes in the production processes may lead… Read More »
Confusion exists in Brazil over generics
2014-07-16 Brazilians are confused about generics and are unable to distinguish between a generic drug and a brand-name drug [1]. The Brazilian pharmaceutical market is the… Read More »
Australia to adopt EMA’s monoclonal antibody guideline
2014-07-14 The Therapeutic Goods Administration (TGA), Australia’s regulatory body for therapeutic goods, announced on 14 February 2014 that it was carrying out public consultations on the… Read More »
France to allow biosimilars substitution
2014-07-10 Pharmacists in France will now be allowed to substitute a biosimilar for the prescribed (reference) biological under certain conditions, including only when initiating a course… Read More »
Impact of coupons on adherence to statins
2014-07-08 Once patents expire, in an effort to maintain market share, originator manufacturers often initiate promotional activities such as drug samples and co-pay discount coupons that… Read More »
Use of formularies could increase use of biosimilars
2014-07-04 Whether or not the US Food and Drug Administration (FDA) permits automatic substitution of biosimilars, healthcare systems can still consider using formularies as a way… Read More »
Biosimilars: what physicians need to know
2014-06-03 A biosimilar is a medicinal product that is similar to a biological medicinal product that has already been authorized. Biologicals are comprised of proteins, such… Read More »
