The Price and Market Share Evolution of the Original Biologics and Their Biosimilars in Finland

Background Biological drugs are generally expensive and produce a continuously growing share of drug costs. Yet they are essential in the treatment of many chronic diseases. Biosimilars, clinically equivalent to biological originator products, are expected to restrain drug costs in the biological market. Objective This study aimed to examine the impact of the biosimilar market entry on the prices of the reference products in outpatient care in Finland, investigate the impact of biosimilar market entries on price competition among biological medicinal products, and examine how the prices and market shares of outpatient biosimilars have developed in Finland during 2009-2020. Methods This retrospective register study applied data from IQVIA covering national community pharmacy wholesale data between 1 January, 2009, and 31 August, 2020, for somatropin, epoetin, filgrastim, follitropin, insulin glargine, insulin lispro, etanercept, pegfilgrastim, adalimumab, teriparatide, and enoxaparin biosimilars and their reference products, in addition to two relevant insulin products. We determined the monthly wholesale amounts in defined daily doses and wholesale weighted average prices (excluding value-added tax) per defined daily dose for each product. We analyzed the evolution of the price and market shares. We performed a linear segmented regression analysis to examine the impact of the market entry of biosimilars on the prices of reference products. Results The prices of the reference products mainly decreased after the biosimilar entered the market. If the reference product price was not reduced, it was no longer reimbursable after evaluation under the Health Insurance Act, leading to marginal market shares. The changes in the prices of biosimilars were not as remarkable as the changes in the prices of reference products after the biosimilar market entry. For most active substances, biosimilar prices were stable or decreased. The utilization of biosimilars varied widely between different active substances at the end of the observation period. Conclusions Changes in pricing policy and the public reimbursement scheme related to the market entry of biosimilars were the main reasons for the decrease in the prices of reference products. Therefore, biosimilars did not generate genuine price competition between biological products. In many of the drug groups examined, the market shares of biosimilars have growth potential in the future.Peer reviewe

Biosimilaarin kauppaantulon vaikutus viitevalmisteen hintaan sekä biosimilaarien hinta- ja markkinakehitys Suomessa

Lääkekustannukset ovat kasvaneet vuosittain maailmanlaajuisesti. Merkittävän osan lääkekustannuksista aiheuttavat biologiset lääkkeet, jotka ovat usein hyvin kalliita, mutta välttämättömiä monien kroonisten sairauksien hoidossa. Biologisten alkuperäisvalmisteiden kanssa kliinisesti samanarvoisten biosimilaarien oletetaan tuovan helpotusta lääkekustannusten nousuun. Biosimilaarien kehitysprosessissa ei tarvitse toistaa kaikkia alkuperäisvalmisteen kehitysprosessin vaiheita, jolloin biosimilaari voi tulla markkinoille alkuperäisvalmistetta alhaisemmalla hinnalla alkuperäisvalmisteen patentin rauettua ja markkinointia koskevan suoja-ajan päätyttyä. Tämän tutkimuksen tavoitteena oli selvittää, millainen vaikutus biosimilaarien kauppaantulolla on viitevalmisteiden hintoihin avohoidossa Suomessa, ja tutkia saavatko biosimilaarit aikaan hintakilpailua biologisille lääkkeille. Lisäksi tutkimuksessa tarkasteltiin, miten avohoidon biosimilaarien hinnat ja markkinaosuudet ovat kehittyneet Suomessa. Tutkimuksessa tarkasteltiin adalimumabin, etanerseptin, glargininsuliinin, lisproinsuliinin, enoksapariinin, filgrastiimin, pegfilgrastiimin, somatropiinin, follitropiini alfan, teriparatidin ja epoetiinin biosimilaareja ja niiden viitevalmisteita. Tutkimusaineistona käytettiin IQVIA:lta saatuja tietoja tutkimuksen kohteina olevien valmisteiden apteekkitukkumyynnistä ajanjaksolta 1.1.2009–31.8.2020. Aineistosta määritettiin kullekin valmisteelle tukkumyynnillä painotettu keskihinta sekä tukkumyynti kuukausittain, ja näiden pohjalta analysoitiin valmisteiden hinta- ja markkinakehitystä. Lisäksi toteutettiin lineaarinen segmentoitu regressioanalyysi, jolla tutkittiin biosimilaarien kauppaantulon vaikutuksia viitevalmisteiden hintoihin. Tutkimuksessa havaittiin, että viitevalmisteiden hinnat pääosin laskivat biosimilaarin kauppaantulon jälkeen. Jos viitevalmisteen hinta ei laskenut, se menetti sairausvakuutuslain mukaisen korvattavuuden. Viitevalmisteiden markkinaosuudet olivat marginaalisia korvattavuuden menettämisen jälkeen. Biosimilaarien hinnoissa ei pääosin tapahtunut yhtä suuria muutoksia kuin viitevalmisteiden hinnoissa, ja suurimmalla osalla lääkeaineista biosimilaarien hinnat pysyivät tasaisina tai laskivat. Biosimilaarien käyttö vaihteli paljon eri lääkeaineiden välillä. Tutkimuksessa viitevalmisteiden hintojen havaittiin laskevan lähinnä erilaisten lääkepoliittisten muutosten seurauksena. Tästä syystä biosimilaarien ei nähty synnyttävän aitoa hintakilpailua biologisten valmisteiden välille. Monissa tarkastelluissa lääkeaineryhmissä biosimilaarien markkinaosuuksilla nähtiin kasvupotentiaalia tulevaisuudessa.Pharmaceutical costs have been rising globally every year. A significant portion of drug costs is caused by biological drugs, which are often very expensive, yet essential in the treatment of many chronic diseases. Biosimilars are clinically equivalent to biological originator products and are expected to alleviate the increase in drug costs. The biosimilar development process does not need to repeat the complete development process of the originator product, allowing the biosimilar to enter the market at a lower price than the originator after the patent and data protection period for the originator ends. The aim of this study was to find out what impact the market entry of biosimilars has on the prices of the reference products in outpatient care in Finland, and to investigate whether biosimilars create price competition for biological drugs. In addition, the study examined how the prices and market shares of outpatient biosimilars have developed in Finland. The study examined the development of price and market shares for adalimumab, etanercept, insulin glargine, insulin lispro, enoxaparin, filgrastim, pegfilgrastim, somatropin, follitropin alfa, teriparatide and epoetin biosimilars and their reference products. The data for the study was acquired from IQVIA and it covered pharmacy wholesale data between 1.1.2009–31.8.2020 for products under investigation. The weighted average wholesale price and monthly wholesale amounts were determined for each product, and the development of the price and market shares were analyzed. In addition, a linear segmented regression analysis was performed to examine the impacts of market entry of biosimilars on the prices of the reference products. According to the study, the prices of the reference products mainly decreased after the biosimilar entered the market. If the price of the reference product did not fall, it lost its reimbursement under the Health Insurance Act. The market shares of the reference products were marginal when they were no longer reimbursed. The prices of biosimilars did not change as much as the prices of reference products, and for most active substances biosimilar prices remained stable or decreased. The use of biosimilars varies widely between different biologics. The study found that prices of reference products were decreasing mainly as a result of various changes in drug policies. Therefore, biosimilars were not seen to generate genuine price competition between biological products. In many of the drug groups examined, the market shares of biosimilars had future growth potential