Biosimilars
EMA risk management plans may increase prescriber confidence in biosimilars
In the absence of observational (phase IV) data, EMA’s stipulation that all marketing applications for new generation biosimilars contain individual risk management plans may help to increase prescriber confidence in the compounds [1].
Registration of biosimilars in Europe and the US
Europe is way ahead of the US in terms of biosimilars regulation. A legal framework for approving biosimilars in the EU was established in 2003 and guidelines for an abbreviated registration process were issued in 2006 [1].
Spinnovation enters biosimilar collaboration with Quantum Tessera
Dutch-based bioanalysis specialist Spinnovation Biologics (Spinnovation) announced on 24 January 2012 that it had entered into a collaboration with US-based consulting company Quantum Tessera.
Factors affecting market access of biosimilars
Growth in the use of biosimilars is being driven by the need to reduce healthcare costs, patent expiries on blockbuster originator biologicals and better-defined regulatory pathways.
Production of 24 biogeneric products in Iran by 2012
According to reports on Iran’s English-language television network, Press TV, Iran is making significant advances in biogeneric products and biotechnology drugs and is planning to start the production of 24 additional biogeneric products drugs by the end of 2012.
Amphastar and Watson launch biosimilar enoxaparin
US generics manufacturer Watson Pharmaceuticals announced on 26 January 2012 that Amphastar Pharmaceuticals and Watson had been granted their request for a stay of the preliminary injunction preventing the companies from marketing or selling Amphastar’s enoxaparin sodium injection.
Sandoz starts phase III trials for biosimilar filgrastim and pegfilgrastim
On 19 January 2012, Sandoz, the generic drug division of Swiss drug giant Novartis AG, announced that it had started two phase III clinical trials, one for biosimilar filgrastim (Amgen’s Neupogen) for the US market and the other for its global pegfilgrastim (Amgen’s Neulasta) development programme.
Physician perceptions of generics substitution
How do physicians perceive generics substitution? Many patients do not communicate with their physicians regarding out-of-pocket expenses or medication choices. Therefore, understanding physicians’ perceptions about the quality and efficacy of generics could help to identify potential barriers to increasing the use of generic drugs [1].
Roche encounters manufacturing issues with epoetin-beta
The Spanish regulatory agency has found deviations in the quality of the manufacture of Switzerland-based F. Hoffmann-La Roche’s biological anaemia treatment Mircera (methoxy polyethylene glycol-epoetin beta), a long acting erythropoiesis-stimulating agent; and is recommending patients to change to other epoetins.
Relative effectiveness and cost minimisation for biosimilars
The second of two articles on the use of economic evaluations to guide the use of expensive treatment.
