Roche Korea recently decided to withdraw its Parkinson’s disease treatment Madopar Tab from the Korean market due to the appearance of a generic product and the consequent lowering of its price.
However, the decision triggered patients’ moves calling for the drug’s resupply.
According to the Ministry of Food and Drug Safety, Roche Korea voluntarily withdrew permits for two of its products – Madopar Tab and Madopar Tab 125 – on Feb. 6. Madopar is a treatment that contains levodopa, which directly replenishes dopamine in the brain. It won domestic approval in 1992.
Myung In Pharm won approval for Myungdopar, a generic drug of Madopar, in May 2021, forcing Roche Korea to supply its drug at a loss and decide to discontinue it. The local offshoot of the Swiss-headquartered pharma company ended supply last December.
However, Parkinson's disease patients have filed a public petition to allow the original drug to be supplied in Korea again. The petition, posted on Wednesday, has drawn 1,010 co-petitioners until Friday.
“Parkinson's disease is one of the senile degenerative diseases, which slowly stiffens the body without a complete cure,” a petitioner said. “Madopar tablet has been the most commonly prescribed medications, and the only one on which 140,000 patients, including my mother, have relied.”
The petitioner noted that Roche Korea had supplied the drug to Parkinson's patients at a low cost amid little profitability. However, in the course of registering a generic product for insurance benefits to save insurance finance and improve the system, Madopar withdrew completely from the domestic market to be replaced by the generic drug.
“Generic drugs are also tested for biological equivalence just like original drugs, but it’s just research that proves the stability and effectiveness of the copy drugs. Therefore, the equivalence of the absorption rate and amount of the generic and original drugs is not always reflected in the actual treatment effectiveness,” the petitioner said.
The petitioner also pointed out that an increasing number of Parkinson’s patients complain of side effects from Myundgopar, seeking to buy the original drug directly from abroad.
“Since the original drug company announced the upcoming withdrawal of Madopar in August last year, patients were prescribed generic drugs even without knowing why. Moreover, on the internet café of patients where about 27,000 patients and their families communicate, many have posted messages complaining about the side effects of these generic drugs,” the petitioner said.
Noting that some even try to buy the original drug from abroad directly, the petitioner said, “We ask the healthy authorities and drugmakers to resupply original drugs of Madopar and Sinemet tablets for Parkinson’s disease patients suffering from double troubles of securing original drugs and experiencing side effects” the petitioner said.