Some Canadian pharmacists are already stocking their shelves with generic versions of semaglutide, more commonly known by the brand name Ozempic. But will these generics be just as good, and how much will the cost come down?
Three weeks ago, Dr. Reddy’s Laboratories and Apotex Inc. received Health Canada approval to start producing generic semaglutide, a type of glucagon-like peptide-1 (GLP-1). That’s the main ingredient in Novo Nordisk’s Ozempic products, which are prescribed for people with Type 2 diabetes and obesity.
Generics were able to get the green light after Novo Nordisk’s regulatory exclusivity, which protected it from generic competition, ended in January.
In an email to CBC News, a spokesperson for Dr. Reddy’s said its generic version launched in Canada last week and is now available in select pharmacies to patients with a valid perscription, with “broader distribution anticipated nationwide in the coming days.”
While the drugs have already skyrocketed in popularity, specifically for people struggling to shed weight, huge cost savings with generics are expected to lower the barrier even more.
“I think [generics are] a big game changer,” said Brian Rodrigues, a professor in the department of pharmaceutical sciences at the University of British Columbia.
Health Canada approves generic Ozempic
It means more people will likely get on the medication, which has shown to come with a whole host of benefits, including impacts on inflammation, arthritis and lowering the risk of major cardiac events, stroke and early death.
“It’s just fantastic that they now have this generic,” said Rodrigues. “It’s going to make a big play in reducing the incidences of obesity and therefore diabetes and therefore the long-term complications associated with this condition.”
Despite this, there’s still questions around whether generics will stack up to Novo Nordisk’s brand name version.
While both the brand name version and the generics use the same active ingredient — semaglutide — in a once-weekly injection, they are made differently.
According to Rodrigues, Ozempic is made using a more complex process involving both bio-technological and chemical processes.
Generally, Ozempic is made by taking a GLP-1 gene and putting it into yeast, said Rodrigues. The yeast, which rapidly reproduces, will then make the gene in “excess amounts.”
The GLP-1 molecule is then isolated and purified, says Rodrigues. Once that is done, the company needs to modify the molecule
“It’s a long, laborious process that makes it really expensive,” he said.
But with advances in technology and general understanding, generics are now being made using a more streamlined chemical process, says Rodrigues.
“What happens with the generics, all they do is they take these amino acids and they physically build [them] up like a Lego set, so it’s the same molecule eventually, but it’s just made differently,” he said.
Since generics are exactly the same type of drug as the brand name version, they will work the same way in the body, said Rodrigues.
That means common side effects like nausea, vomiting, diarrhea and constipation, would be the same, he said. And more serious, but rare, side effects will also be the same — that includes pancreatitis, bowel obstruction or gallstone attacks.
In an email to CBC News, Health Canada said it “authorized the drug after a thorough review of evidence provided by the company demonstrating that the drug meets Health Canada’s criteria for safety, effectiveness and quality for generic drugs.”
It continued to say that generic semaglutide drug submissions are complicated, and the manufacturer must show that any differences do not affect the drug.
In order to ensure everything is up to code, Health Canada will even do site visits, according to Mina Tadrous, an associate professor at the University of Toronto who researches drug policy.
“Health Canada reviews that process to ensure it’s aligned with good manufacturing practices,” he said.
“The real thing that they’re worried about in the end, is the end product. Does that end product have any byproducts that have never been administered to a human before? Is the molecule the same?”
Indian drugmaker Dr. Reddy’s has facilities in India, the United Kingdom and Mexico.
Meanwhile, Canadian manufacturer Apotex has five facilities in the country.
Despite this, a spokesperson for Apotex told CBC News in an email that because its semaglutide injectors “require a sterile injectable facility,” they will be manufactured in India by one of their partners.
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According to Tadrous, it’s common for drugs to be produced elsewhere.
“The vast majority of drugs we get in the country are in some way made in another country,” he said.
“Even the major producers like China and India have some components coming from other countries. It’s a global market and this is the way that the drug supply chain works.”
He added that India, in particular, is a large producer and so it’s no surprise that that’s where Apotex is sourcing from.
At this time, there are no confirmed prices for the generics from Dr. Reddy’s or Apotex. When asked, Dr. Reddy’s told CBC News it would be “competitive” pricing.
But based on how Canada’s drug pricing system usually works, experts are making some estimates.
Ozempic pens can cost roughly $300 to $400 a month. Typically, the first generic will be around 75 to 85 per cent of the brand price, says Tadrous.
With three or more products on the market, prices will likely drop to around 35 per cent of the brand price, he says.
“Depending on the … strength you are on, that can mean that for some patients, the cost of the drug before dispensing fees and markup could be around $100 a month,” said Tadrous.
Health Canada has said it is still reviewing other versions of generic Ozempic, with several other submissions pending approval on its website.
