Iran has succeeded in producing analog insulin pens, called Basalin. Officials claim that in the near future there will be no shortages in the Iranian pharma market, despite being hit by US sanctions. According to the CEO of Iran’s Diabetes Society, however, Iran’s new insulin is insufficiently tested, and experts are worried that the Iranian government might have sacrificed quality for “self-sufficiency”.
Just as Iranian officials were announcing that Iran has finally become a producer of analog insulin pens, many believed that Novo Nordisk, the first foreign pharmaceutical to set up production in Iran, might finally be starting its production.
But the announcement had nothing to do with Novo Nordisk’s new factory. Officials were talking about a new brand of insulin in Iran, named Basalin.
According to experts and pharmacists, Iran’s newly introduced insulin is not completely an Iranian national product. “The Basalin pen contains biosimilar insulin from China,” according to Amir Kamran Nikousokhan, the CEO of Iran’s Diabetes Society, talking to Danwatch.
An internet search indicates that there is one analogue insulin type with the same brand name produced by a Chinese company, Gan & Lee.
China, the solution
Chinese company Gan & Lee first launched Basalin in 2005. The company specializes in making biosimilar medicines.
Biosimilar insulin is a copy of an original insulin product. In the case of Basalin, it is a biosimilar Glargine Insulin comparable to the insulin brand Lantus produced by Sanofi.
Biosimilar products are comparatively cheaper and reduce the treatment costs for diabetes patients.
Basalin is quite popular in China. In 2017, it ranked second in the Chinese Glargine Insulin market. Sanofi’s Lantus was the top at the time, having more than 50 percent of the market share.
Iranian Pharmaceutical company Pooyesh Darou launched the insulin brand Basalin in Iran June 2020. Officials and media celebrated the news as a step toward independence and an end to shortages of imported insulin pens.
But Iran’s independence stories like this one are usually bound in one way or another to China.
A source from the Iranian pharmaceutical Pooyesh Darou confirmed that the Iranian version of Basalin is a “transfer of technology” from a Chinese company “bought by Sandoz”.
According to information shared on Swiss pharmaceutical Sandoz’s website, in December 2018 the company entered into an agreement with the Chinese company Gan & Lee in order to commercialize and market the insulin that Gan & Lee manufactures.
Sandoz announced that their aim is to develop biosimilar versions of top selling types of insulins in the market.
A threat to foreign providers
The development of a new Iranian insulin pen might be a threat to several foreign pharmaceuticals already providing a similar advanced insulin to hundreds of thousands of Iranian diabetics.
According to data provided by Iran’s Food and Drugs Administration, around 60 percent of the market for long-lasting insulins belongs to the French company Sanofi’s (Lantus), while the Danish company Novo has 35 percent.
The relatively lower price of biosimilars is one of the reasons that Basalin might be a threat to foreign producers of insulin.
The source from Pooyesh Darou claimed that Basalin is produced and sold at much lower prices than the imported insulin.
Our information from the market, however, does not confirm that claim. The market price of one Basalin pen is around 30,000 toman (300,000 Rial), according to a pharmacist in Tehran. This is around the same price as a Lantus pen. Moreover, the same insurance coverage applies to both products.
Although biosimilar Basalin is not less expensive, patients might still shift to this product because it is more accessible.
“This new PEN from Dooyesh Daroo has come to the market when there was a shortage for imported ones,” according to Akbar Abdollahiasl, Professor of Pharmaceutics at the University of Tehran.
The shortage, or prospect of shortages under sanctions, might be a reason for the government’s attempt to find alternative solutions.
When asked if Basalin can replace Lantus or other types of imported insulins in the market, the source in Pooyesh Darou replied: “We really don’t have a plan to replace any of them. We only try to fill the shortages in the market. This is not also our decision; it is a physician’s decision to prescribe or not to prescribe a certain medicine.”
One question, however, is if Iranian diabetics are ready to trust a Chinese biosimilar product.
“Pharmacists believe,” says Akbar Abdollahiasl, “[that] if availability of Novo and Sanofi become normal again nobody would accept to use the domestic one.”
Safe or dangerous; a question
A number of Iranian physicians are worried about prescribing Basalin for their patients, according to Amir Kamran Nikousokhan, CEO of the Iranian Diabetes Society.
When Pooyesh Darou announced the release of Basilin, experts expressed doubts about its safety, he told Danwatch.
The head of the Iranian Diabetes Society is rather suspicious about this new brand of insulin because, he claims, it is not properly tested in Iran:
“Biosimilar insulin is completely different from other types of insulin and the effect or side effects of Basalin has not been tested in Iran,” says Amir Kamran Nikousokhan.
“We have complained about this, as it might cause serious problems for the patients. We don’t know how long it is effective and it might cause allergic reactions in some patients too.”
The head of the Iranian Diabetes Society emphasizes the severity as “we are talking about a lifesaving drug.”
Pooyesh Darou management refused to speak to Danwatch and Zamaneh about the lack of testing. However, a source from Pooyesh Darou said that the Iranian company has researched the product for seven to eight years before launching it.
Nikousokhan, however, says that Pooyesh Darou has only promised to test the product. But testing a product after it has been distributed is a rather unusual and anti-regulatory approach, he says.
“We had a webinar with the company and they have promised to test it soon, but it is already in the pharmacies. How can I and other doctors prescribe it when not tested?
It has been tested in China, but I have not received the results yet,” Nikousokhan says.
For a long time now, Iranian officials have increasingly complained about the high spending on imported insulin.
Mohammad Reza Shanesaz, the head of Iran’s Drug and Food Administration (IFDA) said in June this year that insulin is one of the most expensive pharmaceutical imports for Iran. He announced that Iran’s new insulin pens can in the near future cover 25 percent of the needs of the market, and it would aim for 50 percent coverage in the next step.
The complaints concern the costs of importing medicine.
The Iranian Minister of Health, Saeid Namaki, said last summer that Iran spends 1.3 billion dollars on imported drugs each year. An Iranian expert talking anonymously to Zamaneh estimates that the size of Iran’s imported insulin market is about something between 200 to 300 million dollars.
It is expected that even though the raw materials are being imported, national production of the medicine is less costly for Iran because of the country’s relatively cheap labour.
“Iran says they want to have insulin production from A-Z in Iran. The government has promised that Iran will produce all kinds of insulin within this year,” Nikousokhan says.
The source from within Pooyesh Darou told Danwatch that the company is also about to introduce short-acting and rapid insulin types. They are already in the production phase and only need to finalize pricing, he claims.
Iran subsidizes insulin twice; initially by providing favourable exchange rates to importer companies and later by providing 90 percent insurance coverage to registered diabetes patients.
However, the government recently had problems paying back the importer companies and providing insulin to patients at the insured price (link to the other article on pricing).
Local production would, therefore, be a big advantage for Iran and a possible solution for the Iranian patients who find it hard to locate and pay for imported products.
“Patients might have to go back to human insulin or try Basalin because of the shortage. I have so many patients calling me, asking what to do, because they cannot find analogue insulin,” says the CEO of Iran’s Diabetes Society.