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Research and Development › Food and Drug Administration (FDA) › Biosimilars

Rothwell, Figg, Ernst & Manbeck, P.C.

Beyond Guinea Pigs: Patent Risks and Opportunities in AI-Enabled Drug Development

Rothwell, Figg, Ernst & Manbeck, P.C. on

On April 10, 2025, the U.S. Food and Drug Administration (FDA) announced a landmark initiative to phase out animal testing in drug development, signaling a major shift toward human-relevant, science-driven alternatives. This...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q1 2024 and Beyond

Goodwin on

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Approves Sandoz Biosimilar for Tysabri®

McDonnell Boehnen Hulbert & Berghoff LLP on

It was not so long ago that many, including members of Congress, were bemoaning the slow approval and introduction into the marketplace of biosimilar alternatives to (generally expensive) biologic drugs.  See "Trump...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Issues Final and Draft Guidances on Biosimilar Development under BPCIA

McDonnell Boehnen Hulbert & Berghoff LLP on

In September, the U.S. Food and Drug Administration issued Final Guidance entitled "Questions and Answers on Biosimilar Development and the BPCI Act: Guidance for Industry," and Draft Guidance entitled "New and Revised Draft...more

Morgan Lewis

FDA COVID-19 Guidance Roundup for Drug and Biologics

Morgan Lewis on

From the beginning of the coronavirus (COVID-19) pandemic, FDA actively provided guidance to members of the drug and biologic industries, including sponsors, investigators, pharmacies, and compounders....more

Hogan Lovells

Life Sciences and Health Care Horizons - 2020

Hogan Lovells on

We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...more

Goodwin

DEAL WATCH: Biosimilars, Biosimilars and More Biosimilars

Goodwin on

It has been a busy week so far for biosimilar developers, with multiple collaboration and commercialization deals announced. First, on November 4, Henlius and Ascentage Pharma announced that they entered into a...more

Hogan Lovells

Four new FDA guidances and proposed rule advance biosimilars policy framework

Hogan Lovells on

Yesterday, FDA released a series of guidances that aim to advance the agency’s biosimilars policy framework, along with a proposed rule on the definition of a “biological product,” which incorporates changes made by the...more

Hogan Lovells

Welcome to the real world: FDA issues long-awaited framework for evaluating the potential use of real-world evidence to support...

Hogan Lovells on

On December 6, the Food and Drug Administration (FDA) published a framework for its Real-World Evidence (RWE) Program to strategically leverage information gathered from real-world data (RWD): data that relates to patient...more

Foley & Lardner LLP

Senate Judiciary Introduces CREATES Act To Expedite Access To Affordable Drugs

Foley & Lardner LLP on

Following months of public outcry and Congressional probes into significant drug price increases, the Senate Judiciary Committee introduced legislation targeting “behavior that blocks competition and delays the creation of...more

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