WHO urged to change biologic drug naming policy

By Kirsty Barnes

- Last updated on GMT

Related tags: Food and drug administration, Fda

The Biotechnology Industry Organization (BIO) urged the World
Health Organization (WHO) to change its International
Nonproprietary Names (INN) policy for biological products at a
meeting last week in Geneva.

The organisation is the latest to weigh into the biosimilar debate as those in the industry argue over whether the WHO needs to update its international naming system to account for the increasingly complex issue of biological products.

BIO, who represents more than 1,100 global biotechnology companies, academic institutions and other related organisations, wants the WHO to assign a unique INN to each distinct biological product, including biosimilars.

Under the current system, traditional generic versions of drugs based on chemical compounds are identical to the reference product and all generic versions of a branded drug are given the same INN - in many EU countries, the branded version can be substituted for a generic version by the pharmacist without consultation with the prescribing doctor.

Serious problems are now arising in regards to biosimilar medicines, however, which unlike drugs based on chemical compounds, are unique products, not generics or identical copies of innovative biological products.

BIO argues that because biological products are different from traditional drugs in their complexity, development and production processes, and each biological product is unique, patients could respond in very different ways to any biosimilar versions than they do to the innovative product.

"Inadvertent substitution of one version of a medicine for another could have negative clinical consequences,"​ said a statement released by BIO president and CEO Jim Greenwood.

"One of our concerns is that current requirements for naming and labelling may lead to inappropriate assumptions about sameness and interchangeability of biological medicines."

Furthermore, BIO points out that if an adverse event occurs with a biological medicine, it is critical that it be traced promptly to the correct manufacturer.

"This tracing would be greatly facilitated if all biological medicines had a distinct INN,"​ said Greenwood.

In unison with BIO, five other trade associations - the European Biopharmaceutical Enterprises, the European Federation of Pharmaceutical Industries and Associations, EuropaBio, the International Federation of Pharmaceutical Manufacturers and the Pharmaceutical Research and Manufacturers of America - also lobbyed the WHO last week on this issue.

A statement released by the European industry body EuropaBio said: "It is necessary to ensure that with the arrival of biosimilar medicines, the traceability, substitution and pharmacovigilance of biosimilar and biological products are harmonised and guaranteed throughout all regions of the world."

EuropaBio said it also "supports the initiative that physicians and healthcare professionals are provided with specific information following the European Medicines Agency (EMEA) guidelines about biosimilar medicines in order to make an informed decision regarding their use."

Indeed, the EMEA has not yet issued its position on the INN matter, although it did recently state that 'due to the complexity of biological/biotechnology-derived products the generic approach is scientifically not appropriate for these products.'

An EMEA spokesperson told In-PharmaTechnologist.com that the organisation is currently "contributing to the process with the WHO" but whether or not it issues a position statement will depend on the outcome of the WHO meeting last week.However, its counterpart across the pond, the US Food and Drug Administration (FDA) has already come out strongly against the proposed INN changes, outlining its objections in a position paper issued on September 1.

The FDA argues that changes to the current INN system are unnecessary and the only way to establish pharmacologic interchangeability is through scientific data, and nomenclature - INNs should not be used as a way to imply such when there are not credible supporting data.

"At this time the FDA does not consider the proposed change to the INN policy for naming biosimilars to be necessary to prevent inappropriate substitution in the US,"​ said the statement.

"The issue of interchangeability is not an issue of nomenclature but a scientific question that needs to be decided on its own merit."

Meanwhile, the generics industry strongly support the FDA's stance and have branded the biotech industry's complaints as commercially motivated and designed to hinder attempts to get biosimilar drugs on the market.

"There is no scientific justification to giving them (biosimilars) a different INN,"​ said the European Generics medicines Association (EGA).

Echoing this, the GphA, the generics industry body in the US said: "This is a political and business tactic carried out by special interests to secure additional market protections."

Related topics: Markets & Regulations

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