Biosimilars in Belgium: a proposal for a more competitive market

Figures & data

Table 1. Reimbursed biosimilars in Belgium, classified by treatment setting for use in non-hospitalised patients (as of January 2020) [3]. Marketing authorization dates for the European Union are indicated between brackets [2]. Molecules are sorted from oldest (on top) to newest biosimilar marketing authorization for the European Union. Please note that marketing authorization is not equal to access to treatment, since reimbursement and product launch usually occur later

Hospital setting (ambulant patients)		Retail setting
INN	Brand name	INN	Brand name
Epoetin	Binocrit® (27/08/2007)	Somatropin	Omnitrope® (11/04/2006)
	Retacrit® (17/12/2007)
Infliximab	Inflectra® (08/09/2013)	Filgrastim	Tevagrastim® (14/09/2008)
	Remsima® (09/09/2013)		Nivestim® (06/06/2010)
	Flixabi® (25/05/2016)		Accofil® (16/09/2014)
	Zessly® (17/05/2018)
Follitropin alfa	Bemfola® (25/03/2014)	Follitropin alfa	Ovaleap® (26/09/2013)
Rituximab	Truxima® (16/02/2017)	Insulin glargine	Abasaglar® (08/09/2014)
	Rixathon® (14/06/2017)
Trastuzumab	Ontruzant® (14/11/2017)	Etanercept	Benepali® (12/01/2016)
	Herzuma® (07/02/2018)
	Kanjinti® (15/05/2018)
	Trazimera® (25/07/2018)
	Ogivri® (11/12/2018)
Pegfilgrastim	Pelgraz® (20/09/2018)	Enoxaparin sodium	-
	Pelmeg® (19/11/2018)
	Ziextenzo® (21/11/2018)
		Teriparatide	-
		Insulin lispro	-
		Adalimumab	Amgevita® (20/03/2017)
			Imraldi® (23/08/2017)
			Hyrimoz® (25/07/2018)
			Hulio® (15/09/2018)
			Idacio® (1/04/2019)

INN: International non-proprietary name

Figure 1. Biosimilar market shares in Belgium, based on volume (defined daily doses) versus the reference product, for the years 2015 to 2019. Data for 2019 are partly extrapolated (EP) based on 6 months of hospital data and 9 months of data for the retail setting. Data were provided by the Belgian reimbursement agency RIZIV/INAMI/NIHDI (Farmanet and DOC PH databases)

Table 2. Implemented policy measures related to biosimilars to enhance competition in the Belgian off-patent biologicals market

Year	Type of measure	Details
2009	Position statement	In 2009, the Belgian competent authority first published information on biosimilars on their website and takes a position on switching and substitution of biological products. This information is regularly updated [13,14].
2016	Prescription target	The Pact of the future that was signed in July 2015 has led in January 2016 to the establishment of a covenant between the government, the pharmaceutical industry and the medical sector, in which they stimulate physicians to prescribe at least 20% biosimilars for treatment-naive patients [15]. They also state that switching from the originator to the biosimilar product is acceptable.
2016	Working group	With the establishment of the covenant, a working group on biosimilars was composed that included representatives from the Belgian reimbursement agency, the competent authority, industry associations, and academia.
2016	Monitoring	In the context of the covenant, biosimilar uptake is monitored and assessed every three months, at least up to June 2017, and compliance of hospitals with the law on public procurement was raised as a point of interest [8]. In December 2018, the Belgian reimbursement agency shared few data on the use of biosimilars since the establishment of the covenant on their website [16]. Reports on biosimilar uptake are shared yearly with members of the working group on biosimilars, but are not made publically available.
2016	Circular letter on tendering	In January 2016, a circular letter from the Minister of Social Affairs and Health addressed hospital administrators, the pharmaceutical and therapeutic committees of hospitals, and hospital pharmacists to conform to the law on public procurement of 15 June 2006, enacted since 1 July 2013, and to include biosimilars in the same lot as their reference product [17]. In addition, the Minister emphasizes that the award criteria must be related to the subject of the contract, and also urges to include a clause that allows hospitals to terminate a contract earlier and open a new tender in case new alternatives are available.
2018	Education	In February 2018, the Belgian competent authority organised a symposium on biological medicines in Belgium, which focused on the use of biosimilars in Belgium, experiences from patient organisations, physicians and other healthcare professionals, and learnings from Norway and the Netherlands [18].
2018	Education	In December 2018, a joint media campaign between the competent authority and the reimbursement agency was set up to provide information on biological medicines, including biosimilars, to patients and healthcare professionals [19,20]. In the context of this campaign, a website was launched with definitions of a biological medicine and of a biosimilar [21]. Also radio spots, posters, patient brochures and banners on websites and social media were used to communicate to the general public.
2018	Reimbursement	From 1 July 2018, the reimbursement procedure for biosimilars has been simplified and shortened from 180 days to 90 days [22].
2019	Financial incentive	For the year 2019, the use of a financial incentive was piloted to increase prescription of biosimilar adalimumab and etanercept in the retail setting [23]. When an annual target of 5%, 10% or 20% of prescribed adalimumab and etanercept biosimilars is reached, €750, €1000 or €1500 will be paid, respectively, to the individual physician to compensate for their efforts to communicate with patients.
2019	Champion	In 2019, a ‘programme manager biological and biosimilar medicines’ was assigned by the Belgian reimbursement agency to study the Belgian biosimilars landscape and come up with solutions to create a dynamic biologicals market [16,24].
2019	Research	For 2019, the reimbursement agency planned to set up a study to map the rationale of physicians behind prescribing a biosimilar or originator product, concerns of physicians and patients, and how much time is spent to communicate with patients on biosimilars [16]. This study is commissioned to a university research group and planned for 2020.
2019	Circular letter on tendering	In June 2019, the competent authority addressed via a circular letter the hospitals, pharmaceutical companies and wholesalers to correctly apply the law on public procurement from 17 June 2016 and the law on medicines from 25 March 1964 [25]. This was done in response of a communication in March of the same year by the Public Procurement Service of the Federal Public Service Chancellery of the Prime Minister, who studied at the request of the Minister of Social Affairs and Health whether the use of additional benefits as an award criterion is conform with relevant legislation [26].
2019	Working group	In November 2019, the Federal Council of Ministers, in the context of determining the healthcare budget for 2020, decided that new measures are needed to increase biosimilar uptake [27]. A new working group is established to give advice by the beginning of March 2020 on how to improve competition in the biologicals market.

Table 3. Price differences between biosimilar and reference product in the retail setting (as of January 2020) [36]

Product	Price difference between biosimilar and reference (%)
Adalimumab 2 units of 40 mg	8%
Adalimumab 6 units of 40 mg	2%
Etanercept 4 units of 50 mg/ml	20%
Etanercept 12 units of 50 mg/ml	17%
Etanercept 4 units of 25 mg/0.5 ml	19%
Filgrastim 5 units of 0.3 mg/0.5 ml	0-3%
Filgrastim 5 units of 0.48 mg/0.5 ml	0-2%
Insuline glargine 5 × 3 ml 100 E/ml	3%

BCFI | Startpagina: Belgisch Centrum voor Farmacotherapeutische Informatie; [ cited 2020 Jan]. Available from: https://www.bcfi.be/nl/start.

 Google Scholar

Download medicine data | European Medicines Agency: European Medicines Agency; [cited 2020 Feb]. Available from: https://www.ema.europa.eu/en/medicines/download-medicine-data.

 Google Scholar

Biosimilars: FAGG/AFMPS/FAMHP; 2009; [cited 2019 Nov]. Available from: https://www.famhp.be/en/human_use/medicines/medicines/MA_procedures/types/Biosimilars.

 Google Scholar

Switch and substitution of biological medicinal products: FAGG/AFMPS/FAMHP; 2009; [cited 2019 Nov]. Available from: https://www.famhp.be/en/switch_and_substitution_of_biological_medicinal_products.

 Google Scholar

Convenant “Doorstart voor biosimilaire geneesmiddelen in België” (Convenant on the use of biosimilar medicines in Belgium): RIZIV/INAMI/NIHDI; 2018; [cited 2019 Nov]. Available from: https://www.inami.fgov.be/nl/themas/kost-terugbetaling/door-ziekenfonds/geneesmiddel-gezondheidsproduct/geneesmiddel-voorschrijven/Paginas/biosimilaire-geneesmiddelen.aspx.

 Google Scholar

Omzendbrief actieplan biosimilars (Circular letter action plan biosimilars): RIZIV/INAMI/NIHDI; 2016; [cited 2019 Nov]. Available from: https://www.inami.fgov.be/SiteCollectionDocuments/omzendbrief_actieplan_biosimilar.pdf.

 Google Scholar

Biosimilaire geneesmiddelen: aanzienlijke besparingen voor het gezondheidszorgsysteem (Biosimilar medicines: significant savings for the healthcare system): RIZIV/INAMI/NIHDI; 2018; [ cited 2020 Jan]. Available from: https://www.inami.fgov.be/nl/themas/kost-terugbetaling/door-ziekenfonds/geneesmiddel-gezondheidsproduct/geneesmiddel-voorschrijven/Paginas/biosimilaire-geneesmiddelen-belangrijk-besparingen.aspx.

 Google Scholar

Omzendbrief Opname van biosimilaire geneesmiddelen in het therapeutisch formularium (TF) door het Medisch-Farmaceutisch Comite (MFC) in uitvoering van de wetgeving op de overheidsopdrachten (Circular letter on the use of biosimilars in the therapeutic protocol of the Medical-Pharmaceutical Committee for the implementation of the law on public procurement): RIZIV/INAMI/NIHDI; 2016; [cited 2019 Nov]. Available from: https://www.inami.fgov.be/SiteCollectionDocuments/omzendbrief_biosimilaire_geneesmiddelen_ziekenhuis.pdf.

 Google Scholar

Archief presentaties (Archived presentations): FAGG/AFMPS/FAMHP; 2018; [cited 2019 Nov]. Available from: https://www.fagg.be/nl/2018_archief_presentaties.

 Google Scholar

Nieuwe campagne om patiënten te informeren over biologische geneesmiddelen en om het voorschrijven van biosimilaire geneesmiddelen aan te moedigen. (New campaign to inform patients about biological medicines and encourage the prescription of biosimilars.): FAGG/AFMPS/FAMHP; 2018; [cited 2019 Nov]. Available from: https://www.fagg.be/nl/news/nieuwe_campagne_om_patienten_te_informeren_over_biologische_geneesmiddelen_en_om_het.

 Google Scholar

Informatiecampagne om patiënten te informeren over biologische geneesmiddelen en om het voorschrijven van biosimilaire geneesmiddelen aan te moedigen. (Information campaign to inform patients about biological medicines and to encourage the prescription of biosimilars.): RIZIV/INAMI/NIHDI; 2018; [cited 2019 Nov]. Available from: https://www.riziv.fgov.be/nl/pers/Paginas/biosimilaire-geneesmiddelen.aspx.

 Google Scholar

Biologische en biosimilaire geneesmiddelen (Biological and biosimilar medicines): FAGG/AFMPS/FAMHP; 2018; [cited 2019 Nov]. Available from: https://www.faggcampagnes.be/nl/biologische-en-biosimilaire-geneesmiddelen.

 Google Scholar

Koninklijk besluit tot vaststelling van de procedures, termijnen en voorwaarden inzake de tegemoetkoming van de verplichte verzekering voor geneeskundige verzorging en uitkeringen in de kosten van farmaceutische specialiteiten (Royal Decree laying down the procedures, terms and conditions for the reimbursement of the mandatory insurance for medical care and in the costs of pharmaceutical specialties): Belgisch Staatsblad; 2018; [cited 2019 Nov]. Available from: http://www.ejustice.just.fgov.be/cgi_loi/change_lg.pl?language=nl&la=N&cn=2018020122&table_name=wet.

 Google Scholar

Biosimilaire geneesmiddelen: incentive voor het voorschrijven van biosimilaire geneesmiddelen buiten het ziekenhuis (Biosimilars: incentive to prescribe biosimilars in the outpatient setting): RIZIV/INAMI/NIHDI; 2019; [cited 2019 Nov]. Available from: https://www.inami.fgov.be/nl/themas/kost-terugbetaling/door-ziekenfonds/geneesmiddel-gezondheidsproduct/geneesmiddel-voorschrijven/Paginas/biosimilaire-geneesmiddelen-buiten-ziekenhuis.aspx.

 Google Scholar

Biosimilars newsletter September 2019: Medaxes; 2019; [cited 2019 Nov]. Available from: https://www.medaxes.be/nl/actualiteit/biosimilars-newsletter.

 Google Scholar

Omzendbrief nr. 646: FAGG/AFMPS/FAMHP; 2019; [cited 2019 Nov]. Available from: https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&ved=2ahUKEwiIotPep43mAhUQblAKHYC2DH0QFjAAegQIBRAC&url=https%3A%2F%2Fwww.fagg.be%2Fsites%2Fdefault%2Ffiles%2Fcontent%2FDC-CT%2F20190625151700.pdf&usg=AOvVaw3vQ8Lp4w3QZCWtvAmVFHNq.

 Google Scholar

Advies van de commissie voor de overheidsopdrachten betreft verenigbaarheid van premies of voordelen als gunningscriterium (Advice of the commission for public procurement concerning compatibility of premiums or benefits as an award criterion): Publicprocurement.be; 2019; [cited 2019 Nov]. Available from: https://www.publicprocurement.be/nl/documenten/verenigbaarheid-van-premies-voordelen-als-gunningscriterium.

 Google Scholar

De begroting van de verzekering voor geneeskundige verzorging in 2020 (The budget for the insurance of medical care in 2020): RIZIV/INAMI/NIHDI; 2019; [cited 2020 Jan]. Available from: https://www.riziv.fgov.be/nl/nieuws/Paginas/begroting-geneeskundige-verzorging-20191122.aspx.

 Google Scholar

BCFI - start: Belgisch Centrum voor Farmacotherapeutische Informatie (BCFI); 2020; [cited 2020 Jan]. Available from: https://www.bcfi.be/nl/start.

 Google Scholar