Lupin gets UK nod to launch generic asthma inhaler drug Fostair

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Lupin's UK subsidiary, Lupin Healthcare (UK), has received the drug regulator Medicines and Healthcare products Regulatory Agency's approval to market Luforbec, the first branded generic of asthma inhalation drug Fostair, the drug maker said on June 14.

Fostair is a combination of beclometasone dipropionate and formoterol fumarate dihydrate of 100/6 µg pressurized metered dose inhaler (pMDI). Fostair is marketed in the US by Italian drug maker Chiesi Farmacehtici.

“We are truly delighted to receive the first marketing authorisation for generic Fostair in the UK. This is an important milestone for our respiratory franchise as we expand our product offering across the globe,” Lupin CEO Vinita Gupta said.

Luforbec 100/6 µg pMDI is indicated for regular treatment of asthma and for the symptomatic treatment of patients with severe chronic obstructive pulmonary disease (COPD), Lupin said in a statement to stock exchanges.

The launch of branded generic version would result in significant savings for the UK government, it said.

"In the twelve months to February 2021, the NHS spent over £179 million on Fostair 100/6µg pMDI and the availability of Luforbec offers significant savings potential for the NHS upon launch," Lupin said.

Respiratory diseases affect one in five people. It is the third biggest cause of death in the UK and is a clinical priority for the NHS.

In the UK, around 5.4 million people are receiving treatment for asthma, which is one in every 12 adults. An estimated 1.2 million people are also living with COPD and this number is only set to increase.

Asthma and COPD place a heavy cost burden on the NHS, estimated at £3 billion and £1.9 billion per year, respectively.