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Is a biosimilar forever or just for Christmas? Posted 24/11/2017

Dr Elena Wolff-Holz discussed the need for clinical studies and the evolution of biosimilars over time. During her keynote address at the biosimilar medicines conference in London, UK, Dr Wolff-Holz highlighted that the ‘need for clinical studies may depend on the size and complexity of the biological and the clinical indications sought. Some examples of this include:

Monoclonal antibody (mAb): Truxima: Single dose pharmacokinetics (PKs) in one therapeutic area plus one comparative phase III trial in other therapeutic area (150 kDa, complex 4 chains, glycosylated polypeptide)

mAb: Remsima/Inflectra: Single dose PK plus one comparative phase III trial in representative indication (150 kDa, complex 4 chains, glycosylated polypeptide)

Epoetin: Single dose plus multiple dose PK/pharmacodynamics (PDs) with safety and immunogenicity in healthy volunteers and patients plus one phase III trial in representative patient population (165 kDa, single chain glycosylated polypeptide)

Filgrastim: Single dose plus multiple dose PK/PD with safety and immunogenicity in healthy volunteers and patients (20 kDa, single chain non-glycosylated polypeptide)

Insulin: Single dose PK/PD data with safety and immunogenicity in healthy volunteers (6 kDa, two-chain non-glycosylated polypeptide)

Teriparatide: Single dose bioequivalence study with safety and immunogenicity in healthy volunteers (3,7 kDA, non-glycosylated 34 amino acid fragment)

Another issue highlighted by Dr Wolff-Holz was that product evolution may lead to drift. This can be in the form of a trend or a shift in attributes. When the drift of an originator and its biosimilar are in opposite directions this can lead to divergence between the two products. This leads to the question: Is the biosimilar just biosimilar at the time of approval or for its lifetime?

Take, for example, an originator that has more presentations/strengths or clinical indications than the biosimilar applicant wishes to pursue at the time of approval. Later, if the biosimilar manufacturer wishes to add any of these extra presentations/strengths or clinical indications, is it:

  • Lost chance = Treat as any other medicinal product → Type II variation??

or

  • Tie back to reference product = automatically grant additional presentations/ strengths/indication as desired at a later time point??

This presents a challenge for regulators. According to EMA’s overarching guideline (CHMP/437/04 Rev. 1) [2], ‘There is no regulatory requirement to repeat the demonstration of biosimilarity against the reference product, e.g. in the context of a change in the manufacturing process, once the Marketing Authorisation has been granted.’

However, according to the agency’s guideline for biosimilars covering quality issues (EMA/CHMP/BWP/247713/2012) [2], ‘It is acknowledged that the biosimilar will have its own lifecycle.’

*Dr Wolff-Holz works at the Paul Ehrlich Institut, Federal Agency for Vaccines and Biomedicines, and is Chair of the Biosimilar Medicinal Products Working Party of the European Medicines Agency’s Committee for Medicinal Products for Human Use.

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References
1. Wolff-Holz E. Welcome Keynote Address. 15th Biosimilar Medicines Conference: Biosimilar Medicines; A game changer for healthcare sustainability; 23−24 March 2017; London, UK.
2. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 24]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars

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