Europe poised for generic Symbicort
pharmafile | February 24, 2014 | News story | Manufacturing and Production, Sales and Marketing | AstraZeneca, CHMP, COPD, Symbicort, Teva, breo, generics
The CHMP has given Teva Pharmaceutical Industries a lift by recommending that its generic version of AstraZeneca’s lung drug Symbicort should be shown the green light in Europe.
However, the positive opinion will be a concern for AstraZeneca which is now looking at losing a sizeable chunk of revenue, as last year sales of Symbicort rose 10% to $3.5 billion.
The company may be cheered by the fact that the drug is doing well in the US, with net sales up 23% year-on-year in 2013 – but the CHMP’s opinion is unlikely to be changed and should be formalised in the next three months.
Symbicort is also under pressure from competitors such as GlaxoSmithKline’s Breo.
Israel-based IsTeva has received the CHMP nod for a combination of budesonide and formoterol, delivered by its Spiromax multi-dose dry powder inhaler, marketed as DuoResp Spiromax.
It will be used for the regular treatment of asthma, and for the symptomatic treatment of patients with severe COPD. “We have planned for strong growth in respiratory,” said Michael Hayden, Teva’s chief scientific officer.
Teva says its portfolio is “projected to be a multi-billion dollar franchise by the end of the decade” and insists the European application is the first “in a number of major countries worldwide”.
“The Committee’s favourable view of the registration dossier for DuoResp Spiromax marks an important step in Teva’s journey to deliver a valuable new treatment option for the treatment of patients with asthma and COPD,” said Rob Koremans, president of Teva Global Specialty Medicines. “We look forward to receiving the final decision from the European Commission.”
Results are also expected this year from two late-stage trials with DuoResp Spiromax in patients with persistent asthma, although final approval does not rest on these.
COPD affects 23 million people in Europe resulting in 1.1 million hospital admissions each year, while 30 million people are living with asthma, causing an estimated 82,000 admissions.
Adam Hill
Related Content
NICE recommends Benralizumab for Rare Form of Vasculitis
The National Institute for Health and Care Excellence (NICE) has recommended AstraZeneca’s benralizumab (Fasenra) as …
NICE approves AstraZeneca’s dual immunotherapy for advanced liver cancer
AstraZeneca has received a positive recommendation from the National Institute for Health and Care Excellence …
Purpose and people: the enduring power of brand and the evolution of employer identity
Two decades ago, terms like purpose and people were rarely at the forefront of branding …
