FDA allows automatic ‘generic’ swap for brand-name insulin



U.S. regulators took motion Wednesday that can make it simpler to get a less expensive, near-copy of a brand-name insulin on the drugstore.

Docs now need to particularly prescribe what’s referred to as a biosimilar or OK substituting it for a costlier brand-name insulin.

Wednesday’s transfer by the Meals and Drug Administration will permit pharmacists to robotically substitute the cheaper model, simply as they do with generic capsules for different kinds of medicine.

It’s the FDA’s first approval of an “interchangeable” biosimilar, a near-copy of an injected biologic drugs that’s manufactured inside residing cells. It might save diabetics and well being plans thousands and thousands of {dollars} yearly and encourage different drugmakers to create extra biosimilar medicines. Well being information agency IQVIA initiatives U.S. financial savings from rising use of biosimilars from 2020 by means of 2024 will prime $100 billion.

The FDA agreed that Viatris Inc.’s Semglee was interchangeable with broadly used Lantus, a fast-acting insulin.

Approval of a second such interchangeable biosimilar of a long-acting insulin seems imminent from the identical builders, Pittsburgh-based generic large Viatris and its companion, India’s Biocon.

Mylan N.V., one in all two corporations that merged to create Viatris final December, launched Semglee within the U.S. final summer time.


Pink tape, prolonged patents and pushback from brand-name drugmakers have restricted U.S. gross sales of biosimilars to far beneath ranges in Europe.

“These merchandise are extremely related however far more inexpensive,” mentioned Sean McGowan, head of biosimilars at AmerisourceBergen, a prime drug wholesaler.

Solely 20 of 29 FDA-approved biosimilars — for most cancers and immune issues like rheumatoid arthritis — are bought within the U.S. up to now, he mentioned.

Relying on the pharmacy, Semglee injector pens value about $150 to $190 with out insurance coverage for a typical month’s provide, in comparison with $340 to $520 for a similar provide of brand-name Lantus.


Comply with Linda A. Johnson on Twitter: @LindaJ_on Pharma


The Related Press Well being and Science Division receives help from the Howard Hughes Medical Institute’s Division of Science Schooling. The AP is solely accountable for all content material.


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