The Pharma Data

MAY 15, 2023

Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.

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Biosimilars Production Government Clinical Trials 40

Agency IQ

AUGUST 2, 2024

While this would not affect existing vouchers, it would prevent FDA from issuing new ones after September 2026. FDA September 30 Deadline for submission of Advancing RWE Pilot Program projects A semi-annual deadline for FDA’s Advancing Real-World Evidence Program is set for the end of the fiscal year.

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FDA Science Regulations Biosimilars 40

Agency IQ

JUNE 9, 2023

Other orphan drugs, which, by definition, address an unmet medical need, “only” receive 9 years of market exclusivity. Reduced market exclusivity would foster generic and biosimilar competition through earlier market access. Generic and biosimilar developers benefit from earlier market entry.

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Marketing Regulations Biosimilars Drugs 40

Agency IQ

FEBRUARY 15, 2024

In other cases, the FDA is under no obligation to release a document at any time, but is instead developing the document on its own accord. We have tried to sort guidance documents by topic area. If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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FDA Science Biosimilars Clinical Trials 40

FDA Law Blog: Biosimilars

OCTOBER 13, 2024

No rare pediatric disease vouchers could be awarded even to designated applications after September 30, 2026. It is extremely difficult, if not impossible, to do the long-term planning and substantial fundraising required for drug development without knowing whether such an important and valuable incentive will be there.

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