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Analyzing biosimilar market dynamics in different patient populations

Drug Patent Watch

Biosimilars have emerged as a game-changing force, promising to revolutionize patient access to life-saving biologics while simultaneously reducing healthcare costs. ”[1] The global biosimilars market is experiencing exponential growth, with projections indicating it will reach $69.4 billion by 2025, growing at a CAGR of 34.2%

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How GPCR-targeting therapies are advancing the fight against inflammatory disease

Drug Target Review

In this article, Stephan Schann, Chief Scientific Officer at Domain Therapeutics , explains why this class of drug target is so useful despite the challenges they present. Despite this, the therapeutic potential of targeting most GPCRs remains untapped, as only 10 percent of GPCRs have been drugged.

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Déjà Vu: OPDP Again Targets Provider Branded Website of Accelerated Approval Drug in Second Untitled Letter of 2025

FDA Law Blog: Biosimilars

According to the Untitled Letter, the FDA previously pointed out concerns about Taihos marketing messages, particularly regarding the selective presentation of efficacy data. The Untitled Letter states that a randomized controlled trial would be needed to assess delay in time to disease progression.

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Every Claim You Make, Every Step You Take…CVM Will Be Watching You

FDA Law Blog: Biosimilars

Further, information presented on the adverse reaction data was inconsistent with the PI. With respect to Altren, the webpage fails to contain any risk information, and a Product Sheet presents benefits and effectiveness information in a large, bulleted format while the risk information is in a smaller font on the second page.

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FDA Inspections: Lesson 1 – Interviewing Employees

FDA Law Blog: Biosimilars

If FDA asks for an interview of a non-designated employee, companies can still be cooperative with the request but insist that designated personnel are present during those interviews and that FDA limit its questions to those that are directly within the employees job description and responsibilities.

FDA
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HPM and Riparian to Co-Host Webinar on CMS Misclassification Penalties Rule

FDA Law Blog: Biosimilars

Date: Wednesday, December 11, 2024 Time: 12:00 PM to 1:15 PM EST Presenters: Alan Kirschenbaum , Director, HPM Jennifer Lospinoso, Managing Director, Riparian LLC Lynn Buhl, Managing Director, Riparian LLC Please click here to register. Once you register, youll receive instructions by email on how to access the webinar.

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ACI’s 23rd Advanced Summit on Life Sciences Patents

FDA Law Blog: Biosimilars

Karst will speak at a session, titled Hitting the Books: Examining Orange and Purple Book Delisting from a Patent Prosecutorial Perspective, along with co-presenters Kim Braslow (Senior Director, IP and Government Affairs, AstraZeneca) and Nicole Woods (Associate Vice President, Assistant General Patent Counsel, Eli Lilly and Company).