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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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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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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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Alvotech and Dr. Reddy’s partner for Keytruda biosimilar

Pharmaceutical Business Review

The alliance leverages both companies’ experience in the field of biosimilars. This agreement demonstrates Alvotech’s ability to leverage its dedicated R&D and manufacturing platform for biosimilars, accelerating the expansion of our pipeline by pursuing growing global markets.

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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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Biocon Biologics gains market access coverage for Yesintek in the US

Express Pharma

Biocon Biologics has secured multiple market access agreements for Yesintek (ustekinumab-kfce), its biosimilar to Stelara (ustekinumab). Yesintek is a monoclonal antibody that disrupts IL-12 and IL-23 mediated signaling associated immune mediated diseases. The available presentations are 45 mg/0.5 mL PFS, 90 mg/mL PFS, 45 mg/0.5

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Expanding Pneumococcal Vaccinations to Healthy Adults Aged 50 to 64 Years Offers Significant Health, Economic Benefits

Pharmacy Times

Prior to October 2024, the Advisory Committee on Immunization Practices (ACIP) recommended use of a PCV only for all adults aged 65 years and older, including those aged 19 to 64 years with risk conditions for pneumococcal disease.