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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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Sandoz breaks ground on new European biosimilar plant

European Pharmaceutical Review

Sandoz has begun construction of a new biosimilars production facility in Brnik, Slovenia. The new high-tech facility will produce both existing and upcoming biosimilar medicines in Sandoz’s portfolio. Ensuring a reliable supply of biosimilars in Europe “… With a commitment of over $1.1

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

Express Pharma

and Europe held manufacturers accountable for their environmental impact, leading to an increase in partnerships with tech companies focused on sustainable packaging and production solutions. Similarly, Dr. Reddy’s and Cipla are exploring the biosimilar and complex generics space, focusing on areas like respiratory and oncology drugs.

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Educating Patients about Generic Drugs: Strategies for Success

Drug Patent Watch

When educating elderly patients: Be patient and take extra time to explain concepts Use larger print materials for easier reading Address concerns about changes in pill appearance or packaging Communicating with Young Adults Younger patients may be more open to generic drugs but might lack knowledge about how they work. ” FDA.gov, 2021.

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

PharmaVoice

But Stelara, which became a megablockbuster in 2023, will leave a revenue gap that J&J has yet to fill as biosimilar competition heats up. In 2024, Johnson & Johnson became the first pharma with two megablockbusters: its immunology drug Stelara and an oncology therapy Darzalex. Here’s how drugmakers are getting there.

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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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Pharmaceutical Technology Excellence Awards 2025: i3 Membrane

Pharmaceutical Technology

Can pharma tariffs “Make America Manufacture Again”?