In its letter the Foundation stated ‘the psoriasis and psoriatic arthritis community is cautiously optimistic regarding the potential of biosimilars: eager for expanded access to effective and affordable therapies, provided a robust safety and monitoring process is in place. The process of approving biosimilars must be transparent at every stage, so that doctors and patients know where the drugs stand, and how they are followed and tracked. Setting and achieving stringent requirements for the approval of biosimilars is vital so that these new treatment options can be prescribed and administered with patient and provider confidence in their safety and efficacy.’

The BPCI Act is seeking to establish an approval pathway for biological products that are demonstrated to be highly similar to products already licensed by FDA. The agency held a public hearing in October 2010 and requested comments from the public on the implementation of the BPCI Act [2]. The National Psoriasis Foundation submitted comments to FDA on 30 December 2010, after in-depth discussions with psoriasis and psoriatic arthritis patients, people who are close to those with psoriatic disease and medical providers who treat psoriasis—dermatologists and rheumatologists [3].

Over the next decade, psoriasis and psoriatic arthritis patients are amongst those most likely to receive biosimilars, with biosimilar versions of Enbrel (etanercept), Humira (adalimumab) and Remicade (infliximab) due to become available. As a representative of these patients, the Foundation also made a number of individual recommendations covering the two main biosimilar topics: safety and efficacy, along with giving recommendations on the patient perspective and pharmacovigilance and robust surveillance

With regard to safety, efficacy and the patient perspective, the Foundation called for appropriate standards for each class, based on the differing levels of complexity and risk, clinical trials that demonstrate no measureable difference in safety or efficacy when switching between reference and biosimilar products, i.e. interchangeability, and substitutions of biosimilars for a prescribed reference product being made by the provider and patient, not by the pharmacist. It also asked for an opportunity for patients and consumer representatives to participate in advisory committees or working groups and the opportunity for providers and patients to select the appropriate treatment modality for psoriasis and psoriatic arthritis [1].

With regard to pharmacovigilance and robust surveillance, the Foundation called for labels for biosimilars that provided accurate, specific and comprehensive information about the actual product and that did not rely on the reference product label. They also requested a strengthening of the tracking, reporting and surveillance of adverse events of both biologicals and biosimilars [1].

Editor’s comment

Evidence is building to suggest that physicians, healthcare providers and patients would use biosimilars more readily if their efficacy and safety data were published.

GaBI Journal would be happy to peer review any such trial data, with a view to publication. If you are interested in contributing a research article to the GaBI Journal, please send us your submission.

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References

1. National Psoriasis Foundation. Letter to FDA; [cited 2011 December 02]. Available from: http://www.psoriasis.org/Document.Doc?id=1394

2. GaBI Online - Generics and Biosimilars Initiative. FDA hearing on biosimilars: focus on characterisation and clinical trials [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 December 02]. Available from: www.gabionline.net/Guidelines/FDA-hearing-on-biosimilars-focus-on-characterisation-and-clinical-trials

3. National Psoriasis Foundation. Background Information on Biosimilars; [cited 2011 December 02]. Available from: http://www.psoriasis.org/document.doc?id=1395