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Biosimilar policies in Spain Posted 16/11/2012

Spain is Europe’s fifth largest pharmaceutical market [1], however, in 2009, biosimilars accounted for less than 5% of the total biologicals market [2].

The Spanish Agency for Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios, AEMPS) is the national authority responsible for regulation of drugs, including biosimilars, in Spain [3].

Substitution and interchangeability
Although Spain supports the early entry of biosimilars, automatic substitution in community pharmacies is not allowed.

Biosimilars are classified in Spain as HOM (hospital only medicine), meaning that they are only dispensed to outpatients attending hospitals, which could offer one explanation for the low uptake of biosimilars in Spain. However, the trend is that a patient, who has received a certain biosimilar in the inpatient phase of their treatment, will continue with the same biosimilar in the outpatient phase.

Pharmacotherapeutic committees decide which biologicals are included in the hospital pharmaceutical formulary and, in general, biosimilars are welcome. The acquisitions are made through, for example, tendering, direct purchase. In case of a lack of supply, it is the job of the pharmacotherapeutic committee to evaluate the substitution of one biological by another.

One problem in Spain is that ‘patents of use’ can protect certain therapeutic indications of the reference biological medicine, meaning that a biosimilar may not include one or more therapeutic indications. In other words, the biosimilar may not include the whole original therapeutic indications, which may represent an inconvenient or legal problem for biosimilars in tenders, for instance.

Pricing and reimbursement
Biosimilars in Spain are priced 30% below the reference biological medicine price, according to an agreement with the Interministerial Commission for Pricing. Conventional generics, on the other hand, are priced 40% below the reference original medicine price.

A Ministerial Order is ongoing, which will set the price of biosimilars by law at 30% below the price of the reference biological [article 93.7 of Act 29/2006 for Guarantees and the Rational Use of Medicines (Medicines Act)].

Biosimilar launches
There are no plans in Spain for early identification of biosimilar launches. One way is to look at the date of the patent expiry for the original product and seek whether the biosimilar has already been authorised by EMA. Then, the marketing authorisation holder in Spain has a three-year period to make it available on the Spanish market.

Finally, there are no existing or ongoing studies with the intent of forecasting the market evolution of biological drugs and the impact of biosimilars. There are also no initiatives in Spain currently ongoing to stimulate/promote the uptake of biosimilars, e.g. through doctors.

Related articles

Biosimilars policies in Italy

Biosimilar substitution in the EU

References

1.  AESEG. La investigación del sector farmacéutico europeo: el caso de España[Spanish] [Investigation of the European pharmaceutical industry: case study of Spain]. February 2009. Available from: http://www.aeseg.es/informeDEF2.pdf

2.  Rovira J, et al. The impact of biosimilars’ entry in the EU market. January 2011.

3.  Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). Misión y Visión de la Agencia Española de Medicamentos y Productos Sanitarios Marzo de 2009 [Spanish] [Mission and vision of the Spanish agency for medicines and health products March 2009] [monograph on the Internet] Spain: AEMPS [cited 2012 Nov 16]. Available from: www.aemps.es/en/actividad/nosotros/mision/home.htm

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