Amgen Exec Backs WHO’s ‘Biological Qualifier’, Says First Ones Could Be Issued By End Of 2017

The World Health Organization’s “biological qualifier” proposal for tracking biologic products on the market has come in for both praise and criticism, with proponents claiming it offers a global approach to ensuring traceability and patient safety and its detractors saying that the BQ would introduce unnecessary complications and that current systems are adequate.

Generic/biosimilar trade bodies have been its most outspoken critics, saying it is not clear how the BQ would add value to existing traceability systems and that it could clash with other naming and coding systems.

Medicines for Europe, which represents the interests of European generic and biosimilar firms, said recently that the EU Falsified Medicines Directive already provides for a future “unique identifier” for biologics and that the new ISO IDMP system being implemented in Europe and other regions will allow sufficient exchange of information.

But many originator biopharmaceutical companies disagree, viewing the BQ as a way of ensuring product-specific traceability in health records and pharmacovigilance reporting.

Amgen Inc. is a case in point. Its executive director of global operations, Gino Grampp, says his company supports policies that ensure biologicals, both originators and biosimilars, are appropriately prescribed, dispensed and monitored. “We are very concerned about a tendency to move towards INN-based prescribing and dispensing by INN, and towards INNs being used in adverse event reports” for biologicals, as is the case for off-patent chemical medicines.

In an interview, Grampp told the Pink Sheet he felt that individual manufacturers should remain responsible for the use of their products, and that clear identification and traceability was “a good way of achieving this. So we support measures to promote product-specific traceability in health records and pharmacovigilance reports, and we believe that identifiers like the BQ or the [US] FDA’s four-letter suffix will help.”

As well as biosimilar companies, the European Medicines Agency and the European Commission don’t see much need for the BQ, which would consist of a randomly generated four-consonant code with an optional two-digit checksum assigned to all biological substances. The system would be voluntary and would be used together with, but not as part of, the INN.

Europe prefers to retain the use of brand names and batch numbers as a means of identification and traceability. But Grampp says this probably isn’t enough. “We are not against the policy in Europe of using unique trade names, but we want more than that. Our preference is that the qualifier will be memorable, and somehow meaningfully linked to the identification of the individual manufacturer.”

He said there was “no need for the EMA to adopt the BQ at the moment, but other WHO member states like Canada, Australia and the US are concerned that this is not good enough and that there are gaps in the system.”

For example, he said, more than 40% of pharmacovigilance reports for filgrastim products received by the Australian Therapeutic Goods Administration were “ambiguous, they said just ‘filgrastim’ with no trade name, so I think there is a need for an option for the member states.”

Interoperability

One question that has been raised by critics of the BQ proposal is how it would work alongside other traceability systems, such as the approach being taken by the US Food and Drug Administration, which involves a four-letter suffix – not randomly generated but suggested by the company and probably having some sort of indication of the company name – attached to the INN by means of a hyphen.

Grampp says this should pose no real problem. “I think they can certainly work alongside each other. The main thing is an alignment of the actual code itself, and this is a jurisdictional issue. Neither the FDA nor the WHO view the code as part of the INN or the active ingredient name. Other countries that have said they are interested in the BQ, like Canada or Australia, may have a different way of using the code together with the INN, but this should still be able to work.”

He added that he was “not too worried about downstream effects of these codes being formatted differently, I’m worried about the code being captured in the first place.”

But he would like to see some form of harmonization of the codes being proposed, suggesting a four-letter code that is upward compatible from the FDA system to the WHO or vice-versa, for example. As to how the code should be generated – randomly or with some sort of indication of the company – he said it seemed the FDA was looking at ways of aligning approaches so that countries like the US, Canada and Australia didn’t end up with different kinds of code.

Moving Ahead

The WHO announced recently that it was moving ahead with a pilot of the BQ initiative, with a three-year impact assessment to be conducted simultaneously. Medicines for Europe told an INN open session on Oct. 18 that questions on issues like interoperability and the format of the suffix needed answering before the pilot went ahead. (Also see "WHO To Pilot ‘Biological Qualifier’ Scheme Despite Protests From Biosimilars Industry" - Pink Sheet, 28 Oct, 2016.)

“The WHO needs to make the option available so that countries interested in the pilot can work out details at their level” – Amgen’s Gino Grampp

But Grampp, who also spoke at the INN session, is all for pressing on. “As Amgen we hope the WHO can move forward now with the pilot. We disagree with some of the objections raised, such as waiting for IDMP and other issues. The WHO needs to make the option available so that countries interested in the pilot can work out details at their level.”

He suggested it would be a good idea to wait for the results of the pilot and then make some decisions based on experience. “This is the WHO’s posture, to see if it works. It is voluntary, and I don’t believe it will be disruptive. The FDA have already started their version of this kind of pilot, let’s look at the data in a few years.”

He does, though, have some reservations about what he sees as the short timeframe of the impact assessment, based on Amgen’s experience with safety databases in Europe, the US and Australia.

“What we have seen is a considerable lag between when a biosimilar enters the market and when you can accumulate enough data – a track record, if you will – in the national pharmacovigilance database in order to draw any kind of conclusions,” he said.

“What I am getting at is that after three years you just start to get a picture of how nomenclature is being used, so the WHO three-year pilot is maybe good enough to look at some aspects of the program but I don’t think it’s quite enough to get an idea of effectiveness in terms of use in the medical system.”

And when might the first BQs be made issued? Grampp thinks the WHO wants to move forward quickly, and says that in theory, based on comments from the INN consultation in April, a BQ could be issued by the WHO within two months of getting the go-ahead for the pilot.

In practice, though, allowing for factors such as applying for the BQ, receiving the suffix, conducting labeling discussions with the health authority, and getting an approval letter, it could take a while longer. “If the WHO took a decision now to make this available you could see it rolling out by the end of next year,” he suggested.

Amgen And Its Biosimilars

Amgen, of course, has a foot in both camps where biologics are concerned. As well as being a pioneering biotech company, it has assembled a biosimilar portfolio that currently consists of Amjevita (adalimumab-atto) – a version of AbbVie Inc.’s Humira that was approved by the FDA on Sept. 23 – and eight pipeline drugs, four of them in oncology. (Also see "Amgen's Amjevita Approved As First Biosimilar To AbbVie's Humira" - Scrip, 24 Sep, 2016.)

And on Nov. 16, Amgen and Allergan announced that they had filed a US Biologics License Application for one of these pipeline products: ABP 215, a biosimilar version of Roche/Genentech Inc.’s Avastin (bevacizumab), which the company believes is the first US submission for a biosimilar bevacizumab.

From the editors of Scrip Regulatory Affairs.