Big firms to discuss introduction of biosimilar substitution in France

Some of the big guns of the biopharmaceutical and generics industries are to take part in a working group set up to determine just how biosimilar substitution is to be implemented in France, following the publication of the 2014 social security financing law (LFSS) allowing pharmacists to substitute a biosimilar for a prescribed biological in certain circumstances.

AbbVie, Amgen, Hospira, MSD, Roche and Sanofi will join representatives of the health and industry ministries, patients, health professionals, and the regulatory body ANSM on the group, which will discuss the content of a decree that is to be drawn up by the health ministry outlining the exact conditions under which substitution is to be carried out, as well as other issues regarding the biosimilars market.

The group's first meeting is set for 7 February. Industry's intention is to ensure that the decree is as clear as possible on contentious points such as the proposed list of biosimilar groups and the need to ensure that substitution is practised only at the initiation of a patient' treatment, says Corinne Blachier, who is director of value, access and policy at Amgen in France and will be attending the meetings of the group.

The French government is keen to promote the use of biosimilars, not least because of their savings potential, but also as a source of inward investment. In a report in July last year on "Health industries and technologies", the Strategic Council on the Healthcare Industries said that France was not producing enough biosimilars, and "like other OECD countries", lacked a clearly defined framework for their use.

As part of a strategy to boost the sector, it was decided to set up a working group in July 2013 to look at how best ensure patient safety, allow healthcare savings and promote the development of the industry. It was noted that a specific framework was needed to allow companies to make biosimilars available and to develop their use by prescribers and patients.

Ms Blachier, who was the industry representative on this group, says it did not really have time to begin its work because in October the government went ahead and introduced the social security financing bill, complete with a provision for biosimilar substitution.

Under this provision, the prescriber can prevent substitution by writing "not substitutable" by hand on the prescription form. Where the biological is being prescribed to a patient for the first time, the doctor must make this clear on the prescription form. When the prescription is renewed, the same medicine should be prescribed and the doctor should write "not substitutable, continuation of treatment".

However, the pharmacist will be able to dispense a biosimilar in place of the product prescribed if the biosimilar belongs to the same "similar biologic group" as the prescribed product, the substitution is made at the initiation of treatment or as continuation of a treatment that started with that same biosimilar, the prescriber has not written "no substitution", and the pharmacist writes the name of the dispensed drug on the prescription form and informs the prescribing doctor.

"Big surprise"

This move came as "a big surprise", Ms Blachier said, particularly as the health authorities had previously insisted the doctor should be in charge of what is given to the patient, and the ANSM had just issued a statement calling for "caution" with regard to substitution. "We had had no signal on this," she told Scrip in an interview. Moreover, she said, "they underestimated the difficulties and didn't think fully about the consequences".

In response to concerns from key stakeholders, who pointed out that France was the first country to go down the route of giving biosimilar substitution a legal basis, the government tried to fine-tune the measure by including safeguards such as allowing doctors to prevent substitution, requiring the pharmacist to inform the prescriber, and so on.

Nonetheless, "we still have a list of concerns", said Ms Blachier, who has been working closely with the industry association Leem in the discussions on the LFSS and the biosimilar provision. One of these concerns relates to the stipulation that a prescribed biological should only be substituted by a biosimilar at the initiation of a patient's treatment, so that the same product is given for the duration of that treatment.

Ms Blachier questioned whether it would be possible for the pharmacist to be sure that the patient was truly initiating treatment – ie, that they had not taken another version of the product for the same condition at some point – before deciding to substitute a biosimilar for the prescribed biological.

Only 30m French patients have electronic health records, which means it is not always possible to say for sure which treatments a patient has had in the past, she observed. While doctors do keep their own records, if a patient moves to another area these records do not necessarily go with them. The authorities have been trying to improve this situation and implement e-records nationwide, but they are not there yet, and so "we lack records for 50% of patients", she said. This could mean that a patient who had taken, say, a G-CSF originator product three years ago and then relapsed could end up being prescribed a different product.

Industry has also flagged up concerns over the plan for the ANSM to draw up a list of product groups containing the reference biological and its biosimilar versions. The plan is to call this a "Répertoire", but this is the same name given to the list of generic product groups, and could lead to confusion between the two, Ms Blachier said.

Moreover, it is not clear what will happen if the biosimilar does not have the same indications, or exactly the same mode of administration, as the reference product. "Can these products be put on this list?" she asked.

Also on the table will be the question of the INN to be given to biosimilars. This is a highly topical issue, with generics firms insisting they should have the same non-proprietary name as the reference product, and many originator firms pushing for biosimilars to have similar, but unique, substance names. In the US, for example, Johnson & Johnson is the latest big company to file a Citizen Petition calling on the FDA not to allow the same INN for biosimilars, citing the possibility of confusion and traceability issues in case of adverse events. The matter is also under discussion at the World Health Organization, which issues INNs.

Starting the talks

Ms Blachier said she planned to meet her counterpart in the health ministry before 7 February – the date of the group's first meeting – to look at the range of topics to be explored, including the decree, market access issues, and last year's recommendations by the strategic council for boosting the biosimilars market. "We must have a broad vision," she declared. Given the sensitivity of the issues involved, "it will be difficult to write this decree", she said.

The ministry will have the final say as to the content of the decree. So how much influence will industry have through the working group? "I hope they take our practical concerns into account," she said. "Sometimes the authorities are very theoretical, but we need to address the practical considerations."

The drafting of the decree has not yet begun, and Ms Blachier could not give an indication of when it might be ready, although she said "I hope that after six months we could deliver something that makes sense."

As for the people who will be carrying out any substitution – the pharmacists – their position remains unclear. "Informally, some pharmacists say they are cautious over issues such as legal responsibility, while others see the possibility of negotiating some financial incentives," Ms Blachier observed.

The pharmacist federation, the FSPF, did not immediately reply to enquiries as to its views on substitution.