Biological Products
This article was originally published in SRA
Executive Summary
Industry debates naming of biosimilars at WHO meeting
Industry debates naming of biosimilars at WHO meeting
Representatives of the biotechnology and generics industry presented their views on the naming of biological products, including biosimilars, at a meeting organised by the World Health Organization (WHO) in Geneva on 13 November 2006. The meeting was called to look at whether the INN system needs to be changed to accommodate developments in the field of biotechnology and biological products, including future products such as gene therapy and cell-based therapies.
The main topic of the meeting was whether biologicals produced by different manufacturers (ie, biosimilars) should have a different INN (international non-proprietary name) from the originator product. The innovator industry supports this option, saying that having a distinct INN would allow the clear identification and safe prescribing and dispensing of biosimilars, and make it easier to trace products that caused adverse events.
The US Biotechnology Industry Organization (BIO) said in its presentation: “Unlike traditional generic drugs, follow-on biologics are not interchangeable with the reference product.”1 In its opinion, giving biosimilars the same INN could lead to “inadvertent substitution of one version of a medicine for another” with “negative clinical consequences”. If an adverse event occurred with a biological medicine, it declared, it was “critical that it be traced promptly to the correct manufacturer. This tracing would be greatly facilitated if all biological medicines had a distinct INN.”
But the generics industry is of an altogether different view. The European Generic medicines Association (EGA) said that if a biosimilar product is approved for marketing by a regulatory agency on the basis of a comparability exercise with the reference drug, it should have the same INN. If, on the other hand, the company fails to show comparability, it will need to ask the WHO for a separate INN2.
Moreover, if biosimilars were to have their own INNs, then the same rule would have to apply to originator biologicals, which have to carry out a comparability exercise whenever there is a change in manufacturing process or cell line, in order to demonstrate that the product's safety and efficacy remains the same, the EGA argued. If a biosimilar has the same INN as the reference drug, it will not lead to traceability or pharmacovigilance problems because whenever a drug is dispensed, the INN plus the brand and/or company name must be recorded, it said. It also noted that having the same INN does not necessarily imply that one product can be substituted for the other - this is a decision to be taken by national governments.
As well as industry, the meeting was attended by representatives of the WHO's INN expert group, the European Commission, the European Medicines Agency (EMEA), the US Food and Drug Administration (FDA), the World Customs Organisation, the World Intellectual Property Organization and the WHO secretariat.
Next steps
According to the European Biopharmaceutical Enterprises (EBE), which is part of the European pharmaceutical industry federation, Efpia, the conclusions at the meeting were that the current INN system is useful and efficient, but that there are some inconsistencies in naming conventions for a few biotechnology products, leading to possible confusion3. As science has evolved, it is time for the INN system to be updated so that the nomenclature for biologicals reflects this evolution, it said.
At a seminar organised in London on 5 December 2006 by the UK BioIndustry Association (BIA), Professor Derek Calam, chairman of the WHO's INN expert group, said that following the November meeting and an earlier one with global regulators, the group has recommended to the WHO secretariat that a review of the nomenclature for biologicals should be carried out.
Current INN policies are generally satisfactory for biologicals, but the WHO needs to anticipate developments in this area and to see what will be coming up over the next few years. For example, the system may need to be changed to address questions relating to products such as monoclonal antibodies, he said. The review will be carried out in the first half of 2007, and will involve consultation with the WHO's expert committee on biological standardisation. Later in the year, the INN expert group will make some recommendations, which Professor Calam said “could have some implications for biosimilars”, although he did not elaborate.
References
1. BIO presentation, 13 November 2006, www.bio.org/news/newsitem.asp?id= 2006_1113_01
2. Personal communication, EGA, 15 November 2006, and EGA presentation
3. EBE press release, 16 November 2006, www.ebe-efpia.org/docs/doc/ PR_BiosimilarsNaming.doc