Biosimilars
Comparability studies and substitution of biosimilars
In order to demonstrate similarity between the biosimilar and the biological reference product, both products must be compared to satisfy quality, safety and efficacy requirements [1].
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.
WHO definitions of biosimilars
Confusion often surrounds terms used in the global field of generics and biosimilars [1].
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FDA issued its long-awaited guidance for biosimilar applications on 10 February 2012 in the form of three draft guidance documents [1].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.
Biosimilars interchangeability, increased costs and burden for FDA
Biosimilars manufacturers in the US are faced with many hurdles, including untested regulatory pathways, patent challenges and manufacturing issues associated with making such complicated molecules. On top of this drugmakers also need to take into account the higher marketing costs that may be associated with biosimilars.
Oncologists urged to embrace biosimilars to help control spiraling costs of cancer care
Oncologists have been urged to embrace biosimilar drug substitution to help control the spiraling costs of cancer care. However, they have been warned that the optimal realisation of such a programme requires successful educational initiatives and the development of effective working partnerships with pharmacists and patients [1].
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?
Biosimilars: demonstrating ‘similarity’
Most biological drugs are mixtures of closely related compounds, some of which are probably more active than others. Today, the state-of-the-art manufacturing struggles to deliver material that is similar to the prior batch from the same facility and team [1]. Identical is currently not possible, therefore ‘similar’ is the route that authorities in Europe and the US are going down.
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).
Quality by design in biomanufacturing
In January 2011, FDA published its long-awaited guidance for industry on Process Validation: General Principles and Practices [1].This replaces the previous 1987 version (updated 2004) and it is understandably a big change for some whose whole career has been dominated by the previous approach. The question is: why was a change needed and how drastic is it?
