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New biosimilar pathways – key takeaways from the EMA’s draft reflection paper

European Pharmaceutical Review

The European Medicines Agency (EMA) has published a draft reflection paper that signals a potential evolution in the regulatory landscape for biosimilar development within the EU. 1,2 The reflection paper also highlights the limitations and diminishing value of CES in many biosimilar development programmes.

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Megablockbusters are the holy grail. Here’s how drugmakers are getting there.

PharmaVoice

Voices Q&A Profiles Biotech Spotlight First 90 Days Opinions Topics Biotech Commercialization Leadership Manufacturing Patient Pharma Policy & Regulation Research & Development Library Events Press Releases PharmaVoice 100 Nominate 2024 PV100 2023 PV100 Sign up Search Sign up Search An article from Megablockbusters are the holy grail.

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Bayer’s Eylea market grip set to slip as Alvotech biosimilar closes in

Pharmaceutical Technology

Alvotech has moved one step closer to entering the Eylea (aflibercept 2 mg) biosimilar market, after a European Medicines Agency (EMA) panel recommended approval of its copycat biologic. Go deeper with GlobalData Reports LOA and PTSR Model - Aflibercept Biosimilar in Age Related Macular. CucuMberStudio via Shutterstock.

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Pharmapack Europe to launch two new zones in 2024

European Pharmaceutical Review

In 2024, Pharmapack Europe, the two-day exhibition and conference for pharma’s drug delivery and packaging industry will introduce two brand new zones to the flagship event. Bio packaging zone . Pharmapack’s bio packaging zone builds on its long history of being at the forefront of innovations in biological drug delivery.

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European Commission authorises one of first ustekinumab biosimilars in Europe

European Pharmaceutical Review

“approval [of Pyzchiva ® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva ® (biosimilar ustekinumab ).

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AI-driven drug discovery, precision medicine, and sustainable manufacturing can redefine the pharma industry

Express Pharma

What are the top 3 trends that defined pharma manufacturing in India and globally in 2024? In 2024, the pharmaceutical manufacturing landscape underwent transformative changes, driven by technological innovations, regulatory adaptations, and evolving global demands. Regulatory bodies in the U.S. and Europe. and Europe.

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November 2023 Newsletter

Safe Biologics

ASBM and GaBI Webinar Examines Policy Challenges to Interchangeable Biosimilars On November 30, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted I nterchangeable Designation for Biosimilars- Ensuring Continuity of Patient Care: Upholding Interchangeability Status for Biosimilars.