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Overcoming challenges in biosimilar analytical characterization

Drug Patent Watch

Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. link] KBDNA. 2024, May 17). link] Lawless, L.

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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., … Boehringer Ingelheim will lay off an undisclosed number of sales reps due to poor U.S. including Boehringer’s Cyltezo.

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STAT+: Pharmalittle: We’re reading about a key Merck drug trial, cheap Wegovy in China, and more

STAT

Keytruda is a cancer immunotherapy, which stimulates the immune system to attack tumor cells and is the best-selling medicine in the world. patent expires in 2028. The subcutaneous injection could be given in a doctor’s office every six weeks, instead of requiring a 30-minute IV drip at the same interval.

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November-December 2024

Safe Biologics

Michael Reilly in RealClearHealth: Don’t Let a “Lame Duck” Congress Gamble with Patient Health On December 20th, RealClearHealth published an op-ed by ASBM Executive Director Michael Reilly discussing concerns that the Biosimilar Red Tape Elimination Act would lower standards for biosimilar medications.

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IGBA releases first global Intellectual Property and Competition Report

Express Pharma

The International Generic and Biosimilar Medicines Association (IGBA) has released a report titled “Gaming the System An Overview of Originator Companies Evergreening Strategies Used to Hinder Access to Generic and Biosimilar Products.” Practices previously seen in the U.S.

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Sandoz receives US FDA approval for biosimilar Hyrimoz® high-concentration formulation

LifeProNow

March 21, 2023 : “Sandoz, a global leader in generic pharmaceuticals and biosimilars, today announced that the US Food and Drug Administration (FDA) approved a citrate-free high-concentration formulation (HCF) of its biosimilar Hyrimoz ® (adalimumab-adaz) injection. Head of North America. “As Head of North America.

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Stelara biosimilar from Alvotech, Teva approved by FDA

BioPharma Dive

The companies plan to launch their copycat version of the blockbuster immune disease drug early next year, per a legal settlement with J&J.