For the latest installment in what’s become somewhat of a routine, European drug regulators are cracking down on data manipulation originating in India’s biopharma industry. This time, it’s Mumbai’s Alkem Laboratories feeling the heat with the news that the EMA is recommending suspension of an ALS drug from the company and is requesting more data on a painkiller that underwent testing there.
During a March 2015 inspection of Alkem’s Taloja site, officials with German and Dutch drug agencies discovered a “misrepresentation of data” during past trials that “cast doubts” on Alkem’s overall quality management. As such, EMA says it is calling for the suspension of not-yet-marketed riluzole by Alkem to treat ALS and demanding more data on Orion's ibuprofen. The generic painkiller underwent testing at Alkem and is currently under EMA evaluation.
In a statement posted on its website, Alkem said it is “considering to provide the alternate studies from other sources to support authorization” in both instances. Alkem maintained there is no documented “harm or lack of effectiveness” tied to the complaints, adding that it "takes quality issues very seriously." European sales were less than 1% of Alkem's total haul last year, according to its statement.
EMA also raised concerns with cefuroxime, an antibiotic offered by Alkem and Krka, but said alternate studies were provided to "support a positive benefit-risk balance." It's allowing those products to stay on the market. Ingen Pharma's cefuroxime, currently under evaluation, was called into question but EMA said alternative studies have been provided in that case as well.
Alkem has 16 manufacturing sites, 5 of which are FDA-approved, according to the company.
While the generics maker is in the spotlight this time around, the development follows a familiar sequence of events for numerous cases involving leading Indian pharma players in recent months and years. In a development that sent shockwaves around the industry last August, EMA suspended 700 drugs tested at Indian CRO GVK Biosciences on data issues, leading to a trade rift and an estimated $1 billion hit to the country's pharma sector.
And it’s not Alkem’s first time getting unwanted attention. Back in 2014, the FDA ordered U.S. Marshals to seize $11 million worth of drugs from an Alkem subsidiary, Ascend Laboratories, claiming the company sold them without going through the steps to get them approved.
- here's the EMA release
- and Alkem's statement
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