Glenmark-Celon Generic Seretide DPI On Its Way In Europe
Executive Summary
Glenmark-Celon’s generic Seretide Accuhaler dry powder inhaler (DPI) appears on course for a debut in Europe, piling up more pressure on GlaxoSmithKline’s respiratory franchise. Substitutability of the generic, however, will be key to driving momentum in uptake.
More competition appears on its way for GlaxoSmithKline PLC ’s Seretide Accuhaler (fluticasone/salmeterol) in Europe, with Glenmark Pharmaceuticals Ltd. and its partner Celon Pharma SA. successfully “closing” the decentralized registration procedure for their generic version in the Nordic region.
The Indo-Polish alliance indicated that national marketing authorizations for the product in Sweden, Finland, Denmark, Norway and Iceland are expected shortly.
Glenmark inked a pact with Celon in 2015 to develop and market a generic version of GSK's Seretide Accuhaler dry powder inhaler (DPI) in Europe. (Also see "Seretide Competition Builds Up But Substitutability Holds Key?" - Scrip, 23 Oct, 2015.) The latest development on the registration front marks the first approval under the duo’s deal and will also represent Glenmark’s first inhaled respiratory product approval in Europe.
Glenmark said that the commercialization of the product would depend on “national approval as well as substitution and pricing approvals”. Celon estimates that the duo should be able to place Salmex (the brand name available for use by Glenmark) on Scandinavian markets in the first half of 2018, a news agency reported.
Glenmark told Scrip that it would apply for interchangeability and the response from the national authorities can be expected “over coming months”. It has also made filings in other markets (including the UK) for the product.
On whether it anticipates additional competition with an identical product since Salmex was essentially developed by Celon, and Glenmark has semi-exclusive marketing and distribution rights for the product across 15 European countries, the Indian company said that it did not anticipate “any other generics over the short term”. Celon has a similar arrangement with Lupin for fluticasone/salmeterol DPI in the US, Canada, Mexico, and other key markets. (Also see "Lupin links with Polish firm to jumpstart Advair generic plans" - Scrip, 19 Feb, 2015.)
Sandoz and Elpen have already launched their generic Seretide DPIs on the Nordic market, while Cipla Ltd. has introduced its Seretide metered dose inhaler in certain European markets. Cipla’s management had recently referred to the product’s “fantastic” launch trajectory in Australia, though the pick-up in the UK appeared to be slow and “playing out” along the lines of the forecasted “long trajectory” for the company there.
Slow Mover?
Analysts, though, appeared to have mixed views on Glenmark-Celon’s generic product and the registration progress; they acknowledged the technological prowess but were cautious about the sales potential, at least early on.
Nimish Mehta, founder of Research Delta Advisors, told Scrip that while the development was certainly a positive from the perspective of validation of Celon/Glenmark’s technology, whether the outcome can be extrapolated to other major markets like the UK and Germany was “anybody’s guess”.
Mehta also believes that in terms of earnings potential (once market authorizations are received), the product could be a “slow mover”, at least initially, and much will depend on the “substitutability” aspect.
Some industry watchers reflected similar views, and noted that the company appeared to have quietly edged past some prominent Indian peers with the generic Seretide DPI version. This more so since it is estimated that DPIs account for bulk of the European market for fluticasone/salmeterol by value. In the Nordic region, they are estimated to account for around 75% of the market by value.
They, however, maintained that moving patients to generic versions of inhaled corticosteroid/long-acting beta 2 agonist (ICS/LABA) combinations was unlikely to be easy.
Informa’s Datamonitor Healthcare had previously reported key opinion leaders as saying that patient switching to generic ICS/LABA inhalers will not be widespread or rapid due to the risk of decreased patient adherence for already stable patients. KOLs also noted that it is difficult to switch patients from one type of device to another, Datamonitor Healthcare said in a report on COPD Pricing, Reimbursement, and Access last year.
Seretide, though, has been losing steam owing to generic competition. At the time of its third quarter results, GSK said that Seretide sales in Europe were down 16% AER [actual exchange rates], 18% CER (constant exchange rates] to £164m (12% volume decline and a 6% negative impact of price), reflecting continued competition from generics and the transition of its respiratory portfolio to newer products. Seretide is, however, among the top three pharmaceutical brands in Europe with sales of $1.1bn as per IMS data.