The European Medicines Agency’s (EMA) recent updates to its biosimilar guidelines will build confidence amongst clinicians and patients, say trade groups representing the EU’s biopharma sector.
In May and June, the EMA released two draft guidelines updating its position on biosimilar copies of biologic drugs. The latter on clinical and non-clinical considerations is currently in the midst of a public consultation period, and the agency convened a workshop on October 31 to discuss amendments to its proposals.
Trade organisations the European Biopharmaceutical Enterprises (EBE) and EuropaBio believe the planned revisions “offer important developments to further strengthen the biosimilars pathway in Europe”, according to Eugene Corretge, strategic unit regulatory head at Sanofi who spoke at the conference.
In particular, the industry is welcoming the increased flexibility a biosimilar developer has in choosing a comparator drug, as well as guidance on deciding whether a biosimilar’s efficacy and safety in one indication can be extrapolated to another.
The EMA’s position is that the primary comparator drug has to be authorised in the European Economic Area (EEA) – something that EBE and EuropaBio agree with entirely.
However, they also welcome the suggestion that non-EEA drugs may be used as comparators for “certain non-clinical and clinical studies”, provided testing shows comparability between the biosimilar, the EEA and the non-EEA versions of the drug.
The issue of extrapolation is critical when the reference drug has more than one therapeutic use, and the biosimilar has to decide whether it needs to carry out studies in multiple indications. The EMA’s guidance indicates that this may be necessary in some but not all instances.
“Data for extrapolation of indications in sensitive population could be required pre-approval,” commented Richard Markus, clinical development lead for biosimilars at Amgen, but he insisted industry is happy with this situation.
“We encourage regulators not to hesitate to ask for more data where it is needed,” said Markus. “This approach may increase regulatory assurance and help build confidence in biosimilars amongst clinicians and patients.”
The guidelines also introduce a risk-based design for non-clinical studies, encourage the use of pharmacodynamic markers to show clinical comparability between original drugs and their biosimilars, and new principles for immunogenicity studies.
The update to the EMA’s 2006 guidance on biosimilars comes at a time when momentum is building in the sector, with the approval earlier this year of Celltrion and Hospira’s copies of Johnson & Johnson’s arthritis and Crohn’s disease treatment Remicade (infliximab) – the first biosimilar versions of a monoclonal antibody to be registered in the EU.
The global market for biosimilars is predicted to reach $2.45bn this year, accounting for around 2 per cent of the total pharmaceutical market, according to Visiongain, which says the roll out of mAb biosimilars will drive growth out to 2023.