Europe is emerging as an attractive route to global market access for Chinese sponsors. Early consideration of EMA requirements can help avoid costly delays and improve approval success. Read the article: https://ow.ly...
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The Next Wave of Biosimilars: Why Hematology Is a High-Stakes Opportunity
A confluence of patent expiries and rising healthcare costs are accelerating both interest and investment in biosimilars across the world. In this article on Citeline we discuss how this relates to one of the major impacted areas, hematology.
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Biosimilar Success in an Evolving Landscape: Development Considerations for Staying Competitive
Regulatory pathways for biosimilars are changing, with reduced clinical requirements placing greater emphasis on analytical comparability and manufacturing excellence. Understanding how to respond to these shifts can make the difference between speed to market and costly delays. Explore the key considerations shaping today’s biosimilars landscape in ICON's latest article.
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Faster Doesn’t Mean Easier: Development Impacts of a New Biosimilar Regulatory Landscape
Regulatory authorities have made it clear that streamlining biosimilar development is a priority, following the example of the EMA and FDA in reducing the requirements for comparative efficacy studies. Read this article to understand the recent changes and their impact.
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Overcoming Formulation Challenges for Biosimilars
Media article discussing how high-concentration formulations and patient centricity are challenges to the formulation of biosimilars, which already face patent protection barriers.
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Preparing For The Biosimilar Era Of ADCs And BsAbs In Oncology
In a recent interview with Citeline, the head of ICON's Centre for Biosimilar Drug Development discussed the upcoming patent expirations in oncology biologics, the opportunities, regulatory pathways and challenges this presents for developers and greater treatment access for patients.
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What sets oncology biosimilars apart: Anticipating key challenges in the development landscape
Advancements in biologic therapies have greatly improved our ability to treat cancer over the last few decades — but are typically very costly. With patent expirations encompassing numerous notable oncology biologics, opportunities for oncology biosimilar development are abundant.
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The Evolving Cost-Benefit Landscape of Biosimilar Drug Development
The patent cliff for biologic medicines presents an opportunity for developers of biosimilars, but historically there are challenges too. The landscape however is changing, supporting easier paths to market.
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Biosimilars in Asia: A strategic approach to regulatory requirements
With the impending patent cliff, the opportunities for companies to create biosimilars is expanding. Read our article in Scrip Asia 100 2025 to learn about the regulatory environment, requirements and challenges in an Asian context.
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The U.S. biosimilars market: Shaking the “laggard” label
An article by Katya Svoboda and Bob Swann which explores the fundamental differences in the regulatory processes and the market dynamics of the US and the EU which account for much of the discrepancy in the uptake of biosimilars.
