Johnson and Johnson scientist testifies for Help committee

A spokesman for Johnson & Johnson has unveiled his principles for the approval of follow-on biologics to a US governmental hearing.

Speaking to a senate health, education, labour and pensions (Help) committee, Dr Jay Siegel outlined five key elements to be taken into account when considering regulatory issues regarding products which are similar but not identical to approved biologics.

The group president of research and development at the biotechnology technology division of the US-based healthcare company commented that a follow-on biologic treatment should not be seen as “interchangeable” with its reference drug.

“Patient safety and welfare are important concerns that we all share and that must guide us as we develop a statutory pathway for follow-on biologics,” remarked the expert.

Dr Siegel added that Johnson & Johnson is looking for a legislative solution to the issue which would provide an appropriate framework for the development of follow-on products but would also encourage innovative research in new areas.

The Help committee is aiming to improve people’s access to follow-on treatments while at the same time protecting patient safety.

Also speaking at the hearing was a representative from the European Commission’s pharmaceuticals unit and the vice-president and head of biopharmaceutical development at the US arm of Novartis.