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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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STAT+: Pharmalittle: Eisai exec who helped lead Alzheimer’s drug development to retire; Express Scripts adds three Humira biosimilars to preferred formulary

STAT

The drug is the first medicine shown to slow progression of the disease, which afflicts some 6 million Americans. Express Scripts will add three biosimilar versions of AbbVie’s blockbuster arthritis treatment Humira to its list of preferred drugs , Reuters notes. The

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Analyzing the impact of biosimilars on biologic drug development pipelines

Drug Patent Watch

Biosimilars, which are biologic drugs that are highly similar to an already approved biologic drug, are transforming the pharmaceutical industry. As patents for original biologic drugs expire, biosimilars are becoming increasingly important, offering more affordable treatment options for patients and healthcare systems.

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

Pharmaceutical Technology

Robert Barrie June 23, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook Bayer’s Eylea is a heavyweight of the ophthalmic drug landscape, approved for a range of eye diseases. Go deeper with GlobalData Reports LOA and PTSR Model - Aflibercept Biosimilar in Age Related Macular. CucuMberStudio via Shutterstock.

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AI-driven biosimilar manufacturing partnership announced

European Pharmaceutical Review

Sandoz and Just – Evotec Biologics have announced a partnership to develop and manufacture multiple biosimilars. Within the agreement, Sandoz will gain access to an artificial intelligence (AI) -driven technology platform that delivers fully integrated drug substance development and continuous manufacturing.

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Sandoz to build Slovenian biosimilar development facility

European Pharmaceutical Review

To support future growth of its biosimilar pipeline, Sandoz is planning to build a Biosimilar Technical Development Center in Slovenia. The company intends to invest approximately $90 million at its site in Ljubljana, Slovenia, to establish a dedicated Sandoz Biopharma Development Center by 2026.

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STAT+: Just how much money do drugmakers gain from patent extensions?

STAT

Extending patent protection doesn’t just stretch a drug’s profits — in some cases, doing so can lead to its most significant revenue period, according to a recent analysis published by the Initiative for Medicines, Access & Knowledge, or I-MAK, a nonprofit advocating for drug pricing reforms.