Biosimilars: Insulin Glargine Look-Alikes and Knock-Offs

There's been recent media attention to another term that physicians and pharmacists dealing with diabetes will need to become more familiar with -- "biosimilars."

What is a biosimilar? It's a biologic product that has proven to the regulatory authorities such as the FDA that it is very close to identical to the imitated biologic product, and has the same clinical results, while being safe. It's apparently a difficult and expensive process to recreate biologic products, because biologics are complex proteins are derived from living organisms that are genetically modified. But if a company can create a me-too biologic, and if they can successfully run it through the regulatory and patent processes, they can market a biosimilar in competition with an existing biologic product.

I really hadn't paid much attention to the concept of biosimilars for diabetes until recently -- but there's lots of attention recently to a biosimilar (AKA a knock-off) being developed to compete with Lantus. Lantus is a brand name of a drug that's created using biologic processes; the other name that you have probably heard for Lantus is "insulin glargine" -- for some crazy reason I never understood, lots of insulin products seem to have the word "insulin" before the other part of the name -- such as "insulin lispro" (brand name Humalog), "insulin aspart" (brand names Novolog and NovoRapid), and "insulin detemir" (brand name Levemir).

I had a hazy understanding that there were companies making and selling glargine in countries such as India and China which don't have the stringent rules (regulatory and/or patent) that protect products in other countries. So, for instance, in the United States, manufacture and sale of insulin glargine is currently protected from competitors -- it can only be purchased under the brand name "Lantus." But if you were in India, you apparently can purchase insulin glargine sold by Biocon under the brand name Basalog or Glaritus, sold by Wockhardt Ltd.

I really hadn't paid attention to issues relating to biosimilars for diabetes until recently -- but there's lots of attention recently to another biosimilar knock-off being developed to compete with Lantus. I found a nice discussion of the issues of biosimilar insulins available on-line: The Emergence of Biosimilar Insulin Preparations-A Cause for Concern?

Turns out that Merck, partnering with other companies, is developing a biosimilar they designate as MK-1293. Like Lantus, it provides long-acting insulin activity. Based on the titles of their studies, it's obvious that Merck plans to have MK-1293 go head-to-head against Lantus (no surprise, there!): in the two Phase 3 studies that are listed at ClinicalTrials.gov, the titles of the studies are The Safety and Efficacy of MK-1293 Versus Lantus™ in Participants With Type 2 Diabetes Mellitus and A Study of the Safety and Efficacy of MK-1293 Compared to Lantus™ in Participants With Type 1 Diabetes Mellitus.

Why bother developing a Lantus look-alike? Well, for one, Lantus sales grew 20% last year [in 2013] to bring in about $7.8 billion for its manufacturer, Sanofi. So if a major pharmaceutical company like Merck can get regulatory approval for its version of insulin glargine, Sanofi could have some heavy-duty competition. (Lilly also has tried to get a glargine generic, but Sanofi sued them for patent infringement, so there will be a delay in Lilly's efforts to invade the Lantus market.)

Should the average consumer be concerned about biosimilars? Well, if you or your insurance company are price-conscious, sure: competition between Lantus and MK-1293 might result in decreased cost for either the original or the biosimilar. Or if you purchase insulin in India or elsewhere where biosimilar versions of insulin glargine are already on the market, yes, you should be concerned: are the biosimilars sold in India equally safe as Lantus? And do they replicate Lantus's duration of action?

Until some company like Merck or Lilly decides to spend the big bucks to do the studies to prove to the FDA and EU and other well-respected regulatory authorities that they have an Lantus Look-Alike that is just as good in its action and just as safe in its safety profile, we just won't know.

But it appears that we'll soon find out.