With many of the biologics facing patent expiry the introduction of biosimilars is increasing. Biosimilars are also receiving attention from payers as it is an opportunity for cost-savings. Understanding the market access drivers and barriers of biosimilars are of the outmost importance for payers and pharmaceutical companies, both for producers of biosimilars as well as the reference products. In order to better understand the market access landscape for biosimilars in Sweden a mapping study was conducted.

A list of biosimilars approved on the Swedish market was identified based on approved biosimilars published by the European Medicines Agency (EMA). The substances were categorised according to use (inpatient/outpatient) and reimbursement status. List price vs. reference product was calculated as well as any tender discount vs. the TLV list price based on in the three largest regions (Stockholm, Västra Götaland, and Skåne).

At the point of the investigation 14 substances had approved biosimilar products in Sweden. All substances except one were included in the national reimbursement scheme. National net price agreements were only used for anti-TNF products. For products considered to be mainly outpatient the price erosion was small (7-22%). For products with the main usage in hospital or the tender market the (net) price erosion is substantial for some products up to 90% of list price.

There is no national strategy for the use of biosimilars in Sweden and the uptake varies between regions. Many products have both TLV reimbursement and participate in regional tender processes but only one category of biosimilars have a national net price agreement. Products with an exclusively outpatient profile are less likely to participate in tenders and price erosion is thus small. For products with the main usage in hospital price erosion is substantial and treatment choice appears to be driven entirely by cost.