News
WHO proposal offers clarity for biosimilar nomenclature
2015-04-15 Following requests from drug regulatory authorities worldwide, the World Health Organization (WHO) has released a draft Biological Qualifier (BQ) proposal on which to base a… Read More »
Biosimilar trastuzumab similar to Herceptin in non-clinical study
2015-04-13 Comparative non-clinical assessments of the proposed trastuzumab biosimilar PF-05280014 and the originator product (Herceptin) sourced in the US and in Europe showed similar structural properties,… Read More »
Use of biosimilars in Europe differs across countries
2015-04-09 In Europe, the use of biosimilars exhibits different rates in different countries. This can lead to inequalities in access to biologicals, for instance, for the… Read More »
Switching and extrapolation of subsequent entry biologics in Canada
2015-04-07 The regulatory framework for biosimilars in Canada explains how their substitutability and/or interchangeability are governed in the country. Biosimilars, which are known as subsequent entry… Read More »
EC expected to dish out more pay-for-delay fines
2015-04-03 The European Commission (EC) is planning to fine French drugmaker Les Laboratoires Servier (Servier) and generics giant Teva Pharmaceutical Industries (Teva) in its latest round of investigations… Read More »
Phase I studies of infliximab and rituximab biosimilars demonstrate pharmacokinetic similarity
2015-04-01 Results of phase I trials of pharma giant Pfizer’s biosimilar infliximab and rituximab candidates have demonstrated similar pharmacokinetic properties compared to the originator products [1,… Read More »
Data protection provisions in CETA
2015-03-30 The trade agreement between the European Union (EU) and Canada has the potential to have a negative affect on the generics industry in Canada [1].… Read More »
Court rules Canadian drug regulators cannot control generics’ prices
2015-03-26 Canada’s Patented Medicine Prices Review Board (PMPRB) has been told that it has no jurisdiction over the pricing of generics. The country’s Federal Court ruled… Read More »
Biosimilar infliximab comparable to Remicade
2015-03-24 Results from a phase III trial have demonstrated the comparability of US-based Epirus Biopharmaceuticals (Epirus) biosimilar (BOW015) to Remicade for the treatment of rheumatoid arthritis.… Read More »
EMA changes transparency plans to increase access to data
2015-03-20 The European Medicines Agency (EMA) has done an about-turn on its data transparency plans after the agency’s draft on the conditions of use for the… Read More »
