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The role of biosimilars in reducing out-of-pocket costs for patients

Drug Patent Watch

Breaking Down Barriers to Affordable Healthcare: The Power of Biosimilars As we navigate the complex landscape of modern healthcare, one thing is clear: the cost of prescription medications is a significant burden for many patients. So, how do biosimilars work? But the benefits of biosimilars extend far beyond individual patients.

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Market Analysis: The Impact of Biosimilars on the Generic Drug Industry in Europe

Drug Patent Watch

The Biosimilar Revolution: How Europe's Generic Drug Industry is Evolving As we navigate the ever-changing landscape of the pharmaceutical industry, one trend is clear: biosimilars are here to stay. In Europe, the generic drug industry is undergoing a significant transformation, driven by the increasing adoption of biosimilars.

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Regulatory considerations for biosimilar clinical efficacy trials

Drug Patent Watch

Unlocking the Potential of Biosimilars: Navigating Regulatory Considerations for Clinical Efficacy Trials As the pharmaceutical industry continues to evolve, biosimilars have emerged as a game-changer in the fight against high healthcare costs. Should the trial compare the biosimilar to the reference product, or to a placebo?

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What to Expect When you are Expecting…a Government Shutdown

FDA Law Blog: Biosimilars

The answers below are based on my experience as a reviewer and compliance officer at FDA during the 5-week 2018/2019 government shutdown. Submissions to FDA that have an associated user-fee will not be accepted during a government shutdown as they do not have the ability to process the payments (PMAs, 510(k)s, PFUDA Program Fees).

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Inside the Russian Pharma Industry: Key Players and Innovations

Drug Patent Watch

The Russian pharma market has experienced significant growth in recent years, driven by a combination of factors, including government support, increasing healthcare spending, and a focus on domestic production. One area that's gaining attention is the development of biosimilars. billion by 2025, with a CAGR of 10.5%.

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Draft Guidance on Biosimilars and Interchangeables Tries to Smooth Path for Post-Approval Changes

FDA Law Blog: Biosimilars

In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy. The top line from FDA for any cGMP-governed industry like these is always going to be that quality matters.

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Sandoz confirms late-stage clinical development plans for proposed biosimilar aflibercept, a key ophthalmology medicine

The Pharma Data

Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept.