Scientific and legal viability of follow-on protein drugs

Biosimilars/Research | Posted 05/08/2009 post-comment0 Post your comment

Since recombinant human insulin (Humulin) became the first recombinant-protein drug approved by the FDA 25 years ago, nearly 100 recombinant-protein therapeutics including other hormones and monoclonal antibodies, have become part of clinical practice. Though small-molecule drugs are more common than recombinant-protein drugs – only one of the top 200 prescribed drugs of 2006 (on the basis of prescription volume) was a recombinant protein – protein-based therapeutics have been used to treat diabetes and anaemia, as well as relatively rarer conditions, such as rheumatoid arthritis, Gaucher's disease, and multiple sclerosis.

In a paper by David M Dudzinski of the Massachusetts General Hospital in Boston, MA, USA, and Aaron S Kesselheim of the Brigham and Women’s Hospital in Boston, MA, USA, in the New England Journal of Medicine, it was concluded that despite the failures of the four bills introduced in US Congress with the goal of creating a viable abbreviated approval scheme for follow-on protein products (sponsored by Waxman, Inslee, Gregg, and Kennedy) to reach floor votes, these bills collectively represent important first steps that should help to stimulate further discourse on salient scientific issues and signal an end to the de facto permanent patent that a recombinant-protein therapeutic currently enjoys, unless substantial clinical trial data are accrued. Anticipating that the legal issues in the United States will soon be resolved, the world-wide generics industry is preparing for product launches of follow-on types of insulin, growth hormone, interferon, erythropoietin, and colony-stimulating factor, with up to 10 companies working on generic versions in each category.

While the FDA waits for its congressional mandate on the follow-on issue, the EMEA continues to work on product-specific guidelines and approves new biosimilars (up till now to erythropoietin, human growth hormone and granulocyte colony-stimulating factor).

Meanwhile, the medical community, in part through collective efforts of professional societies, can help identify and address the scientific issues of follow-on protein products relevant to their specialties. The role of physicians is critical, because in the near future physicians will be tasked by governments, hospitals, and health-management enterprises to support the use of follow-on protein products. It will be essential that physicians feel confident about their safety and efficacy. Physicians will also be intimately involved in long-term pharmacovigilance programmes. To complete these tasks, physicians must be aware of the salient scientific and legal issues underlying the approval of follow-on protein products to ensure that their patients’ interests in safety and efficacy are adequately represented in a system that promotes lower cost and expanded access to protein therapeutics.

Source: N Engl J Med. 2008;358(8):843-9.

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