Patients and biosimilar interchangeability

Generics and biosimilars Initiative

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Patients and biosimilar interchangeability

Biosimilares/Investigación | Posted 07/09/2012 0 Post your comment

Biopharmaceuticals or biologicals are complex medicines produced by living cells. Copies of approved biologicals have been introduced recently. Because of their intrinsic complexity such copies are similar but not identical to the reference medicine and are therefore called ‘biosimilars’. Approval of biosimilars requires a full quality analysis including a detailed comparison to the reference whereas non-clinical and clinical evaluations are less extensive.

For small molecule generics the issue of substitution is easy, since they are considered identical to the originator molecule. This, however, is not the case for biosimilars, which are large complex molecules prone to heterogeneity. It is therefore important to keep in mind that inherently related to the complex nature of biologicals, similarity is not equal to interchangeability.

In the US, the BPCI Act gives FDA the authority to designate a biosimilar as interchangeable with its reference product. This means that the biosimilar may be substituted for the originator product by the pharmacist without reference to the prescribing physician [1]. This is not the case, however, in the EU, where decisions on interchangeability are not made by EMA, but at the national level.

Some physicians therefore believe that switching between biosimilars and originator biologicals in a patient should be prevented. However, although biosimilars may differ noticeably from each other and from originator biologicals, this does not make them inferior, just different.

Others believe that public policies on biologicals and biosimilars should take into account the ‘biologicals experience’, the variety of support services and programmes provided by originator manufacturers to support patient and prescriber use of existing biologicals. Patients should expect that evaluation of interchangeability and pharmacy-level substitution policies focus not only on minimising costs but also on ensuring optimal health outcomes.

No matter what physicians, patients or indeed payers think, with increasing pressure on healthcare budgets to reduce costs it seems that biosimilars are set to become an important part of the future medicines market.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Interchangeability of biosimilars in the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2012 Sep 7]. Available from: www.gabionline.net/Biosimilars/News/Interchangeability-of-biosimilars-in-the-US

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Source: GaBI Journal