European Pharmaceutical Review

DECEMBER 12, 2023

The first stage of construction has officially begun on Lek Pharmaceuticals’ new biologics and biosimilars production centre in Lendava, north eastern Slovenia. The new biosimilars production centre will also include facilities for manufacturing and storage. The site employs 775 people full time, Sandoz said.

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European Pharmaceutical Review

SEPTEMBER 26, 2023

The European Commission (EC) has granted Sandoz the first marketing authorisation of biosimilar Tyruko ®* (natalizumab). Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. The site is planned to be completed by 2026.

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Pharmaceutical Business Review

OCTOBER 1, 2024

Fresenius Kabi and Formycon signed an international commercialisation deal in February last year for the ustekinumab biosimilar candidate for various markets across the globe. Otulfi is said to be the fourth biosimilar of is Fresenius Kabi to receive marketing authorisation in the US.

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FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

This amendment marks the first significant revision of Part 820 since 1996, which established the Quality System (QS) regulation and “included requirements related to the methods used in, and the facilities and controls used for, designing, manufacturing, packaging, labeling, storing, installing, and servicing of devices intended for human use.”

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Safe Biologics

AUGUST 23, 2024

as in most advanced nations, a prescribing physician may substitute any biosimilar for its reference product. However, substitution of biosimilars at the pharmacy level is controversial, opposed by majorities of physicians worldwide, and banned in many countries including most of Western Europe. In the U.S. In the U.S., In the U.S.,

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