Q: I have a prescription for Budesonide 400mcg/dose/ Formoterol 12mcg/dose dry powder inhaler. We usually supply Symbicort Turbohaler® but our PMR is suggesting a product called Fobumix Easyhaler 320mcg/9mcg Inhalation Powder®. What should I supply?

A: Fobumix Easyhaler is a new dry powder inhaler device containing budesonide and formoterol. It is currently available as 320mcg budesonide /9mcg Formoterol strength:

Fobumix is the second generic budesonide/ formoterol dry powder inhaler available within the UK. It is clinically equivalent to both Symbicort and DuoResp and can be interchanged according to the licensed indication where a prescription is written generically.

Fobumix Easyhaler  budesonide/formoterol

Equivalent Symbicort Turbohaler  budesonide/ formoterol

Equivalent DuoResp Spiromax   budesonide/ formoterol

80mcg / 4.5mcg

100mcg / 6mcg

none

160mcg / 4.5 mcg

200mcg / 6mcg

160mcg /4.5mcg

320mcg / 9mcg

400mcg/ 12mcg

320mcg/ 9mcg

Product equivalence

The Fobumix SPC[1] advises “Fobumix Easyhaler and Symbicort Turbohaler fixed-dose combination of budesonide and formoterol have been shown to be bioequivalent with regard to total systemic exposure and exposure via the lungs” consequently patients would be expected to experience the same benefit from treatment with either inhaler device.

CHMP[2] and EMA[3] assessment reports have demonstrated the equivalence between DuoResp and Symbicort this equivalence can be extrapolated to include Fobumix Easyhaler.

Licensed indication

Neither Fobumix nor DuoResp are licensed for the treatment of children or adolescents under the age of 18 years, whilst Symbicort 100/6 is licensed for the treatment of children from 6 years of age and the 200/6 and 400/12 are licensed for use in children 12 years and over.

Fobumix 80mcg/4.5mcg and Symbicort 100/6 are both licensed only for the treatment of asthma whilst the higher strength inhalers are all licensed for both asthma and COPD.

Product description

The generic description (from Dictionary of Medicines and Devices) is:

  • Budesonide 400 micrograms/dose Formoterol 12 micrograms/ dose dry powder inhaler

The differing strengths of DuoResp, Symbicort and Fobumix inhalers all match this generic description and can be supplied against generic budesonide/ formoterol dry powder inhaler prescriptions.

Metered and delivered doses

The apparent difference in strength of the branded product compared to the generic description is misleading. The branded description states the delivered dose that leaves the mouthpiece whilst the generic description states the equivalent metered dose. The equivalent metered and delivered dose is shown in the table below:

Delivered dose.                                       Budesonide/ Formoterol

Equivalent Metered dose.            Budesonide/ Formoterol

80/4.5

100/6

160/4.5 

200/6

320/9

400/12 

 Pricing

The current Drug Tariff price (March 2021) for budesonide/ formoterol dry powder inhalers is based on Symbicort. Whilst currently pharmacists will not be out of pocket by supplying Symbicort against a generic prescription it would be reasonable to assume that the tariff price will be corrected to reflect the availability of generic inhalers.

Product

List price (March 2022)

Symbicort (all strengths)

£28

DuoResp (all strengths)

£27.97

Fobumix Easyhaler 320/9

£21.50

 Practical advice

Pharmacists should ensure that patients:

  • agree to a switch in their inhaler device
  • are counselled on the correct use of the new device
  • are counselled on potential taste differences

Prescribers should be advised that where they or their patients have a specific preference for one particular inhaler this should be specified on the prescription to ensure correct supply. In the absence of a specific product being prescribed then any of the inhalers discussed could be supplied.

In the interests of consistency and patient adherence to the prescribed treatment the same inhaler type should be supplied each month, i.e. do not swap between Symbicort, DuoResp and Fobumix inhalers. A record should be made on the patient’s PMR of the correct device to supply.

The following table shows the similarities and key differences between Symbicort, DuoResp and Fobumix dry powder inhalers:

Criteria

Fobumix

Symbicort

DuoResp

80/4.5

160/9

320/9

100/6

200/6

400/12

160/4.5

320/9

Licensed for Asthma

P

P

P

P

P

P

P

P

Licensed for COPD

X

P

P

X

P

P

P

P

Licensed Treatment Age (years)

18

18

18

6

12

12

18

18

Pack size (doses)

120

120

60

120

120

60

120

60

Special Storage Requirements

As packaged 2 years,                      After first opening of foil wrapping 4 months

Shelf life 2 years.                           Keep the container tightly closed, in order to protect from moisture

Shelf life 3 years.                Keep the mouthpiece cover closed after removal of the foil wrap


[1] Fobumix 80mcg /4.5mcg Summary of medicinal Product Characteristics: accessed on 18/05/17

[2] CHMP assessment report: DuoResp Spiromax; Committee for Medicinal Products for Human Use (CHMP); EMA/CHMP/175692/2014; 20 February 2014

[3] European Public Assessment Report for DuoResp Spiromax; Summary for the public; European Medicines Agency; EMA/121020/2014; EMEA/H/C/002348