Are Basaglar and Lantus the same?
Basaglar and Lantus are considered by some countries to be biosimilar biomedical products, and often called biosimilar by online writers – although they are not considered biosimilar by the US FDA. What exactly does this mean? Will they function the same for you?
Basaglar is often called a generic version of Lantus – but is not. What is a generic medicine? Why is Basaglar not a generic?
The responses to these questions can be subtle, and requires the use of very specific vocabulary in the context of medical drugs: “biological”, “generic”, “biosimilar” and “interchangeable.”
Biological vs conventional drugs
A biological drug is different from a conventional drug. A conventional drug has a specific, simpler chemical composition that is exactly the same across all examples of this drug, and that is clearly defined. it is typically (although not always) produced as the result of a chemical reaction. The FDA writes: “Conventional drugs are made of pure chemical substances and their structures can be identified.”
On the other hand, to quote the FDA: "Biological products are made from living organisms […] Biological products are manufactured through biotechnology, derived from natural sources or, in some cases, produced synthetically.
“Most biological products are more complex in structure and have larger molecules or mixtures of molecules than conventional drugs (also called small molecule drugs). […] Most biologics, however, are complex mixtures that are more difficult to identify or characterize.”
Similarly, the UK NHS writes (PDF): “Biological medicines are derived from living cells or organisms and consist of large, highly complex molecular entities which may be difficult to characterize. Due to the variability of the biological system and the manufacturing process, biological medicines may show a certain degree of variation, even between batches of the same product.”
A generic drug is an exact chemical copy of a conventional (small molecule) drug that, in general, used to be patent-protected, but whose patent protection has run out. The approval of a generic drug approval by a regulatory agency means hat its manufacturing process is reliable enough to provide a high certainty of the quality of each of its batches.
Biosimilar biological drugs
There are no “generic” biological drugs. The closest equivalent concept is “biosimilar.” This is how the US FDA defines “biosimilar”:
“A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product. Only minor differences in clinically inactive components are allowable in biosimilar products.”
The UK NHS explains (PDF): “A biosimilar medicine is a biological medicine which is highly similar to another biological medicine already licensed for use. It is a biological medicine which has been shown not to have any clinically meaningful differences from the originator biological medicine in terms of quality, safety and efficacy. Biosimilar medicines are not considered generic equivalents to their originator biological medicine because the two products are similar but not identical. However, they will have met regulatory requirements in terms of comparative quality, safety and efficacy.”
Therefore, biosimilar drugs are biological products that have the active part of their chemical composition largely identical to that of a reference product, but which are possibly or likely, as a whole, chemically different, and which have been shown by clinical studies to be statistically equivalent to the reference product for most patients.
Interchangeable biogical drugs
This does not mean, however, that biosimilar drugs have been shown to be functioning similarly for all patients. For that, there is another word, “interchangeable.” Again, the US FDA writes:
“An interchangeable biological product, in addition to meeting the biosimilarity standard, is expected to produce the same clinical result as the reference product in any given patient.”
Basaglar vs Lantus
Lilly, which produces Basaglar, states that “BASAGLAR is a long-acting insulin with an identical amino acid sequence to Lantus®”, which means, at the very least, that the active part of the drug has the same chemical sequence as Lantus (although it may not be, for instance, geometrically the same, and therefore could have difference properties). The UK National Institute for Health and Care Excellence (NICE) calls Basaglar (Abasaglar in the UK) a biosimilar to Lantus, and has documented clinical study results that prove it: “In 2 randomised controlled trials (RCTs) insulin glargine biosimilar (Abasaglar) was as effective as insulin glargine (Lantus) at reducing HbA1c levels in people with type 1 and type 2 diabetes. The safety profile of Abasaglar is comparable to that of Lantus.”
The US FDA does not call Basaglar a biosimilar to Lantus for regulatory reasons, because Lantus was not introduced under the Affordable Care Act (a requirement for the reference product if the follow-up product is to be called biosimilar for the US FDA). But it is likely that it is considered as such: “The applicant demonstrated that Basaglar was sufficiently similar to Lantus to scientifically justify reliance, and also provided Basaglar-specific data to establish the drug’s safety and efficacy for its approved uses. […] Basaglar is not approved as a biosimilar product. No insulin glargine products are currently licensed under the Public Health Service Act, so there is no “reference product” for a proposed biosimilar product.”
However, there is no evidence that Basaglar would be an interchangeable product to Lantus.
So, our conclusion should be that:
Basaglar is chemically close to Lantus but may not be the same
Statistically, Basaglar behaves in the same manner as Lantus for groups of people. So it is likely that it would behave the same for you.
It may not behave the same for individuals. So there is a possibility that you could be an exception to the statistics.
US FDA on biosimilars (1): https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241718.htm
US FDA on biosimilars (2): https://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/
UK NHS on biosimilars (PDF): https://www.england.nhs.uk/wp-content/uploads/2015/09/biosimilar-guide.pdf
Lilly Basaglar introduction: https://investor.lilly.com/releaseDetail.cfm?ReleaseID=947336
FDA Basaglar temporary approval announcement: https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm477734.htm
UK NICE Abasaglar Evidence Summary: https://www.nice.org.uk/advice/esnm64/chapter/key-points-from-the-evidence
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