Biosimilars/News
European biosimilars market to reach almost US$4 billion by 2017
According to researchers at Frost & Sullivan, the European market for biosimilars will experience strong growth in the coming years due to patent expiries of blockbuster biologicals between 2010 and 2017. Cost containment strategies being implemented by governments and healthcare service providers are also given credit for shifting sales towards cheaper biosimilars.
Pfizer and Biocon’s biosimilar insulin deal is off
Pfizer, the world’s largest pharma company, and Indian biosimilars major Biocon announced on 12 March 2012 that they had decided to end their biosimilar insulin deal due to ‘differing priorities’.
Biosimilar alliance between Celerion and Ricerca
Contract research organisations (CROs) Celerion and Ricerca Biosciences announced on 29 February 2012 the formation of an integrated service solution for the development of biosimilar products.
FDA discusses biosimilars guidance
FDA issued its long-awaited guidance for biosimilar applications on 10 February 2012 in the form of three draft guidance documents [1]. In a webinar on 15 February 2012 FDA discussed some of the issues surrounding biosimilar products and expanded on some of the requirements contained within the guidance documents.
Regulation of biosimilars in the US
The US pharmaceutical industry plays a vital role in shaping the face of American health care. With major patent expiries and thin product pipelines, the industry is now considering new directions to maintain growth and stability. Biological drugs, derived from living organisms, represent a growing opportunity for big pharmaceutical firms. They command high prices, will probably have fewer firms making them than generics due to high barriers to entry, and play to the existing strengths of big pharma firms. But will the recent healthcare legislation provide the way for consistent FDA regulation? What is the most likely way in which biologicals will enter the market over the next few years?
Successful completion of biosimilar infliximab programme
South Korean biotechnology company Celltrion announced on 1 February 2012 the successful completion of the company’s clinical programme for its (CT-P13) biosimilar of Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).
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.
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.
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.
