Biosimilar (Generic) Insulin

You may not have heard of biosimilar insulin, but it could end up being very important in your life, especially if you're a diabetic, or if you're suffering from respiratory distress syndrome or deep vein thrombosis. Biosimilar drugs are those which are interchangeable with the pre-existing standard drugs already in use, but which are more generic while being structurally similar.

The use of biosimilar drugs is a transitional approach which was first enacted by the FDA in the Biologics Price Competition and Innovation Act of 2009. At that time, Congress implemented a 10-year timeline wherein stakeholders could prepare for a transition to using biosimilar products which could be shown to be equally effective as their established counterparts. The FDA is already accepting applications from companies manufacturing biosimilar insulin and other drugs, which they would like to bring to market.

Advantage to consumers

As you might guess from the name of the 2009 Act itself, the whole point of this transition of regulatory control is to allow for price competition from generic drug manufacturers. It has been shown historically that the introduction of even one competitor in a market which was previously closed, can have the immediate impact of lowering the cost of such drugs between 15% and 30%.

For users of insulin and other drugs, this could actually be a lifesaver, since many patients lack the health insurance coverage to purchase expensive insulin drugs on their own. With theoretically many more choices available, there is little doubt that the pricing for such drugs will be driven downward, and will be much more affordable for patients who need them.

Immediate impact of the Act

In the wake of this transitional period, the FDA has had to step in to discourage anti-competitive business practices, so that a more competitive marketplace can be obtained for biosimilar drugs. It has also had to issue a more definitive explanation of the entire process, and to provide guidance for industry hopefuls who wish to enter the marketplace.

In addition, it is been necessary to provide formation for healthcare providers as well as patients, to explain exactly what this transitional period means to them, and what they can expect from an expanded marketplace. As applications are made for approval on new biosimilar drugs, the database maintained by the FDA for licensed biological products will be expanded to include applicants whose products are approved.

The FDA is also working closely with companies intending to produce biosimilar, interchangeable products, so that product development can proceed efficiently, with an increased expectation of approval.

A new era

With the age of biosimilar insulin and other drugs now upon us, there will definitely be a far more competitive market in place for transitioning products that are interchangeable. This will empower patients by lowering the prices of high-quality drugs, providing them with potentially many more choices than they've ever had before. With a much more vibrant marketplace in existence, patients will have greater opportunity to secure the medications they need, and at significantly lower cost to themselves.

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