Final answer:
Semglee (insulin glargine-yfgn) was FDA approved as interchangeable for its reference product, Lantus, in July 2021. This marks substantial progress for diabetic patients, allowing for potentially reduced costs and enhanced accessibility to insulin through the use of biotechnology and genetic engineering.
Step-by-step explanation:
The insulin that was FDA approved as interchangeable for its reference product, Lantus, as of July 2021, is Semglee (insulin glargine-yfgn). This approval by the FDA signified a major step forward for patients who rely on insulin for the management of diabetes.
Interchangeability means that this biosimilar product can be expected to produce the same clinical result as the reference product in any given patient. Moreover, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of switching back and forth between the biosimilar and the reference product is not greater than the risk of using the reference product without such switching. This approval is a benefit as it allows for more options at the pharmacy and may reduce medical costs.
The technology that makes the availability of insulin such as Semglee possible is known as biotechnology or genetic engineering. This innovation involves the use of recombinant DNA techniques to produce human insulin in bacteria, which is structurally identical to the insulin produced by the human pancreas.