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FDA permits automated ‘generic’ swap for brand-name insulin



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

Medical doctors now must particularly prescribe what’s known as a biosimilar or OK substituting it for a costlier brand-name insulin.

Wednesday’s transfer by the Meals and Drug Administration will enable pharmacists to mechanically substitute the cheaper model, simply as they do with generic drugs for different kinds of medication.

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

The FDA agreed that Viatris Inc.’s Semglee was interchangeable with extensively 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 big Viatris and its associate, India’s Biocon.

Mylan N.V., one in every of two firms that merged to create Viatris final December, launched Semglee within the U.S. final summer season.

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

“These merchandise are extremely related however rather more reasonably priced,” stated Sean McGowan, head of biosimilars at AmerisourceBergen, a high drug wholesaler.

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

Relying on the pharmacy, Semglee injector pens price 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.


Observe Linda A. Johnson on Twitter: @LindaJ_on Pharma


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


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