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Regulatory Requirements Prescription Drugs European Medicines Agency (EMA)

Goodwin

Alteogen’s Aflibercept Biosimilar Receives Positive CHMP Opinion

Goodwin on

​​​​​​​We previously reported that South Korean biopharmaceutical company Alteogen submitted its Marketing Authorization Application to the European Medicines Agency (“EMA”) for ALT-L9, what has since been named EYLUXVI. ...more

Goodwin

EMA Adopts Positive Opinions for Multiple Biosimilars

Goodwin on

In its June 2025 meeting, the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) adopted positive opinions for six biosimilar medicines. ...more

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

How the U.S. Compares to Europe on Biosimilar Approvals and Products In the Pipeline – Updated January 13, 2025

Biosimilars, once a niche segment in the pharmaceutical industry, are now making a significant impact on global healthcare. These products are highly similar to an already-approved reference product, offering a more...more

Goodwin

A Look Ahead in Life Sciences: What We Are Tracking in Q4 2023 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

American Conference Institute (ACI)

[Event] Global Legal and Regulatory Summit On Biosimilars - December 3rd-4th, Munich, Germany

Legal, Regulatory and Commercial Perspectives on the International Biosimilars Marketplace - The Global Biosimilars market is expected to grow robustly. Market watchers anticipate that Europe in particular will experience...more

Hogan Lovells

The EMA has published a Concept paper for a Guideline for the development of medicinal products containing allergens to treat rare...

Hogan Lovells on

On 13 December 2018, the EMA published a “Concept paper on a Guideline for allergen products development in moderate to low-sized study populations”. Four EMA guidelines concerning medicinal products containing allergens are...more

Hogan Lovells

EMA publishes draft guideline on the quality of water for pharmaceutical use

Hogan Lovells on

The EMA has published a draft Guideline on the quality of water for pharmaceutical use. The draft is intended to provide guidance to the industry. It concerns the pharmaceutical use of different grades of water in the...more

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