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STAT+: Pharmalittle: We’re reading about Boehringer biosimilar frustrations, FTC warnings, and more

STAT

sales of its biosimilar version of AbbVie’s blockbuster arthritis treatment Humira , STAT reports. That led to less uptake of biosimilar versions of Humira in the U.S., IPV is made by only two companies — Sanofi Pasteur and Serum Institute of India, which started its supplies in 2021.

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The US biosimilar market: Predictions for 2021

pharmaphorum

It has been five years since the first biosimilar launched in United States market—marking the first steps in expanding access to innovative biologic-based treatments that help patients manage and treat difficult illnesses such as cancer, rheumatoid arthritis, and other life-altering diseases. million patients.

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ASBM Comments on FDA Draft Guidance Removing Interchangeability Statement from Interchangeable Biosimilars

Safe Biologics

The guidance removed the interchangeability statement from the product label/package insert of interchangeable biosimilars. state law, only interchangeable biosimilars may be substituted by a pharmacist without contacting the prescriber. The agency has approved 44 biosimilar products, including seven interchangeable biosimilars.

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Biosimilar Updates 2021

Med Ed 101

FDA-approved biosimilars have been compared to a biologic and shown to be highly similar in structure and function. At the time this article was written, there are currently 31 FDA-approved biosimilars. The post Biosimilar Updates 2021 appeared first on Med Ed 101.

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Opinion: Shortages of generic drugs can’t be blamed solely on group purchasing organizations

STAT

In 2021 alone, the use of generic and biosimilar drugs saved $373 billion in health expenditures. More than 90% of prescriptions filled that year were for generics or biosimilars, up from just over 18% the year that Hatch-Waxman was passed. Today, however, generic drugs seem to be a victim of their success.

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ASBM Submits Comments Opposing CMS Proposal to Permit Medicare Part D Plans to Substitute Non-Interchangeable Biosimilars

Safe Biologics

In November, the Centers for Medicare and Medicaid Services (CMS) announced a Proposed Rule that would permit Medicare Part D plan sponsors to substitute non-interchangeable biosimilars in place of the biologic medicines now used to treat many chronic conditions such as rheumatoid arthritis, Crohn’s disease and cancer.

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Recent Adalimumab Biosimilar Developments

Big Molecule Watch

FDA grants interchangeable designation to Pfizer’s adaliumumab biosimilar – On October 5, 2023, Pfizer Inc. Food and Drug Administration (FDA) has designated ABRILADA (adalimumab-afzb) as an interchangeable biosimilar to HUMIRA (adalimumab). The post Recent Adalimumab Biosimilar Developments appeared first on Big Molecule Watch.