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Last reviewed dd mmm yyyy. Last edited dd mmm yyyy

Authoring team

Key messages:

  • Biological medicines are medicines that are made or derived from a biological source and as such are complex, with inherent variability in their structure
    • derived from living cells or organisms and consist of large, highly complex molecular entities which may be difficult to characterise
    • due to the variability of the biological system and the manufacturing process, biological medicines may show a certain degree of variation, even between batches of the same product

  • A biosimilar medicine is a biological medicine which has been shown not to have any clinically meaningful differences from the reference medicine in terms of quality, biological activity, safety, efficacy and immunogenicity
    • are well established in clinical practice and offer effective and in many cases vital medicines for acute and chronic conditions including neutropenia, different types of cancers, diabetes, a wide range of inflammatory and autoimmune diseases such as arthritis, psoriasis, as well as enzyme or hormone deficiencies
    • Biosimilar medicines have been used in clinical practice as treatments for growth hormone replacement, neutropenia and anaemia related to chronic renal failure or cancer. Since 2013, the European Commission, on the advice of the European Medicines Agency, has authorised biosimilar medicines for infliximab, etanercept, rituximab, adalimumab, trastuzumab, bevacizumab, enoxaparin, insulin glargine, insulin lispro, teriparatide, follitropin alfa and pegfilgrastim, to add to those already approved; somatropin, filgrastim and epoetin alfa

  • A biosimilar medicine is not the same as a generic medicine, which contains simpler molecular structures. Generic medicines contain active ingredients that are identical to the originator medicine
    • A biosimilar contains a version of an active substance of an already approved biological medicine, which is referred to as the 'reference medicine'. Similarity to the reference medicine must be established based on a comprehensive biosimilar comparability exercise, such that they do not have any clinically meaningful differences from the reference medicine in terms of quality, biological activity, safety, efficacy and immunogenicity. Comparability is a well-established concept, used to evaluate manufacturing changes in biological medicines

  • for a biosimilar medicine to be approved, regulatory requirements include comprehensive comparability studies with the reference biological medicine. If a biosimilar is highly similar to a reference medicine and has comparable safety and efficacy in one indication, safety and efficacy data may be extrapolated to other indications already approved for the reference medicine, if scientifically justified. This avoids the unnecessary repetition of clinical trials.

  • where NICE has already recommended the reference biological medicine, the same guidance will normally apply to a biosimilar of the reference medicine

  • Biosimilar medicines are considered to be highly similar and therapeutically equivalent to the reference biological medicine. As a result, the prescriber can switch a patient from the reference biological medicine to its biosimilar

  • the decision to prescribe a biological medicine for an individual patient, whether a reference or biosimilar medicine (or to change between the two), rests with the responsible prescriber in consultation with the patient; in line with the principles of shared decision making. This should be in accordance with the approved indications on the summary of product characteristics (SmPC) and ideally be part of a biological medicines review.

  • Biological medicines, including biosimilars, should be prescribed by their brand name and not by the international non-proprietary name (INN), in line with MHRA guidelines and to support ongoing pharmacovigilance


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