Norway has approved biosimilar versions of the biologicals somatropin, epoetin, filgrastim and infliximab. Epoetin and filgrastim are included in a national tender for drugs used in hospitals, in which prices can be reduced by up to 89%. Regional health care is responsible for funding drugs used in hospitals and at home, and it is their responsibility for obtaining the best prices. The H-prescription system in Norway works best to maximize biosimilar competition, as exemplified by the approach taken for infliximab. However, the effect of existing biosimilars on prescriptions has varied .
Since their respective launches, filgrastim, somatropin and infliximab have taken different trajectories. The respective market share for filgrastiim and somatropin are quite high, but it has taken several years to achieve them. Despite the huge discounts on these drugs. However, sales of epoetin and filgrastim are still not comparable to sales of biologicals that do not have biosimilar competition, e.g. pegfilgrastim and darbepoetin, which dominate the market, and which have benefited from successful marketing campaigns.
In 2010, filgrastim was added to a ‘substitution list’, permitting pharmacists to automatically substitute the biological Neulasta with filgrastim, to stimulate price competition for use outside hospitals. Consequently, Amgen, the manufacturer of Neulasta, and the Association of the Pharmaceutical Industry in Norway took the Norwegian State to court. The court ruled that inclusion of filgrastim on the pharmacies’ substitution list was illegal, because the legislation supported only the inclusion of generics, but not biosimilars, on the substitution list. With the case of filgrastim, different levels of discounts have been achieved with and without a tender.
Somatropin is used for home treatment for which the national insurance system pays. Somatropin is not included in any tender, as pharmaceutical tenders in Norway cover only drugs paid for by hospitals. The prices for biosimilar somatropin have been 18‒29% below the average for the originator’s somatropin. The example of somatropin shows the effect of a biosimilar entry with low discounts, little follow-up, and no requirement to use the cheapest product. This has resulted in low market share even after several years on the market and despite intervention by the Norwegian Medicines Agency to recommend the cheapest product .
Biosimilar infliximab was launched in Norway in December 2013 (Remsima [Orion] and Inflectra [Hospira]), and has had a more rapid penetration into the Norwegian market compared to other biosimilars. Orion originally offered a 39% discount on Remsima compared with the Remicade tender price and has offered much higher discounts (72% price reduction) for 2015 .
The ongoing NOR-SWITCH study (results anticipated in 2016) aims to compare the originator drug infliximab (Remicade) with the biosimilar infliximab (Remsima) after switching from Remicade, and will generate safety and efficacy data about treatment with Remsima. It is believed that sales of Remsima may have been inhibited as a result of the study . Nevertheless, experience in hospitals has been positive, and the considerably lower prices for Remsima have already boosted the market share for this drug.
Success post-launch of biosimilars requires a combination of actions. The tender process in Norway makes it easy for biosimilars to enter the healthcare system quickly if their price is sufficiently low, and to become the recommended drug for all approved indications. Close contact between specialists, clinicians, pharmacists, patient organizations and the pharmaceutical industry is an important foundation for success. Knowledge and guidance for use are also needed to generate successful biosimilar uptake.
Conflict of interest The authors of the research paper  declared no conflicts of interest.
Editor’s comment Readers interested to learn more about biosimilars pricing policies in Europe are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
What pricing and reimbursement policies to use for off-patent biologicals? – Results from the EBE 2014 biological medicines policy survey
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