Provide names of other journalists involved.
none
List date(s) this work was published or aired.
Jul-11
Provide a brief synopsis of the story or stories, including any significant findings.
There is broad public enthusiasm for the development of “similar” versions of biotech drugs, which many payers and providers expect to be less costly than many high-priced brand-name therapies. The article describes the many technical and regulatory hurdles facing biosimilar developers, which will make these products more costly to produce and to obtain. The aim is to inform executives at pharmaceutical, biotech and generic drug companies of the complexities of the new policy and issues to consider in tackling this field.
Explain types of documents, data or Internet resources used. Were FOI or public records act requests required? How did this affect the work?
The article is based on presentations at conferences on this topic over several months last year, as well as review of legal and regulatory documents.
Explain types of human sources used.
Interviews with FDA officials, patent and reimbursement experts, legislative staff, industry executives.
Results:
none
Follow-up (if any). Have you run a correction or clarification on the report or has anyone come forward to challenge its accuracy? If so, please explain.
no
Advice to other journalists planning a similar story or project.
look beyond projections for great savings and quick product development into the real complexities of the biosimilar R&D process and the looming uncertainty about patent challenges and pricing.