The World Health Organisation (WHO) launched its pilot for prequalification of rituximab and trastuzumab, and corresponding similar biotherapeutic products in June this year.
The programme aims to provide United Nations agencies and WHO member states with guidance on the acceptability of rituximab and trastuzumab biosimilars, for eventual procurement.
According to Emer Cooke, the WHO’s head of regulation of medicines and other health technologies, the programme has attracted interest from drugmakers across the globe.
“We haven’t actually received an application, but we are being actively pursued by manufacturers from five countries in four regions,” Cooke told delegates at the DIA Biosimilars Conference in London last month.Once received, applications will be screened, and assessed, and facilities inspected, by regulatory officials nominated from Argentina, Denmark, Italy, Spain, South Korea and the UK.
“If an inspection has already been performed, or if a clinical trial has already been assessed, we will be able to rely on [that data] as well,” Cooke added.
WHO prequalification steps (simplified)
- Screening for completeness of a submitted dossier
- Assessment of product dossiers, including product data and information
- Inspection of manufacturing sites of Drug Substance and Drug products
- Inspection of clinical sites, if applicable
- Rituximab and trastuzumab are amongst the first monoclonal antibody therapies listed in the WHO Model List of Essential Medicines.
A lack of biosimilar confidence
While at the “forefront internationally”, the biosimilar industry could benefit from collaborative work between industry and regulators, according to Cooke.
“There is a bit of a smokescreen around biosimilars,” she said, referring to common ‘mystification and myths’ surrounding their interchangeability with originator biologics. “I think that we’ve learnt since the first biosimilars were authorised in Europe, but the confidence [in switching from an originator to a biosimilar] hasn’t really increased,” Cooked continued.
“I think the regulatory side is pretty good, but we can work more on working together. We need the industry to help us with that, because with the permission of a [biopharma] company, we can do an awful lot. We can save a lot of resources, for both the company and the regulators,” she told delegates.