Biosimilar Insulin Will Be Available Soon: What It Is and Why It May Help
If you haven’t already, it’s time to add the word “biosimilar” to your diabetes vocabulary.
The FDA has approved a December 2016 launch for the biosimilar insulin glargine, trade name Basaglar.
In the world of pharmaceuticals, biosimilar drugs are a bit like designer knock-offs. They are copies of a biological molecule earlier approved for medical use. The biosimilar Basaglar, for instance, is a copy of the previously approved insulin glargine, popularly known as Lantus.
The patent protecting Sanofi’s Lantus expired last year, leaving other companies free to make their own versions, such as Basaglar, which offers a similar glucose reducing effect for people with type 1 or type 2 diabetes.
However, the making of biosimilars such as Basaglar is a highly sensitive process involving unpredictable living organisms, so the copies are never identical to the original. They carry the same primary amino acid sequence, but differ in more subtle molecular attributes.
Production variations also affect biosimilar products. An original drug’s patent holder does not have to divulge the protocols, techniques, and reagents used in their manufacturing process. Biosimilar makers must substitute their own systems and materials to produce a copy of the prototype.
Since they are not exact facsimiles, biosimilars cannot be automatically substituted for the original medication by a pharmacist, but they should - as generics do - reduce our drug costs.
Biosimilar price reductions are predicted to be modest owing to the expense of developing, manufacturing, and marketing them. Savings of 15 to 20 percent are expected for Basaglar, reflecting the cost reductions reported by countries where this biosimilar was already launched. Generic drugs, in comparison, save consumers 50 to 80 percent over the patented originals.
Still Some Questions
Though the medical community has been eagerly anticipating the release of biosimilars they are not without controversy. It’s unknown whether they will actually improve patient care, or how well they will fare in the marketplace.
When surveyed, diabetes doctors and educators reassuringly expressed the desire for strong evidence that a biosimilar is “equivalent” to its original in every respect. This includes storage, stability, its expiration once in use, and reliability of results.
Insurance companies have also conveyed concern about the safety and effectiveness of biosimilars, wanting clinical confirmation of their interchangeability with the original product—before reimbursing users. However, the FDA stamp of approval on biosimilars such as Basaglar may ease payors' skepticism.
Basaglar is a Lilly/BI product, and other companies are creating insulin glargine biosimilars as well. A biosimilar of the rapid-acting insulin Humalog is also in the works. As more patents expire, we consumers will likely notice a surge in biosimilar pharmaceutical options.