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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Agency IQ

JULY 26, 2024

FDA’s new guidance on postapproval manufacturing changes for biosimilars focuses on current practice, new dosage forms Meeting a biosimilar user fee commitment, the FDA is expanding on its recommendations for biosimilar and interchangeable product applicants asking the FDA for post-approval manufacturing changes.

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FDA Law Blog: Biosimilars

MARCH 5, 2024

AstraZeneca also claimed that CMS’s revised guidance on the Negotiation Program for Price Applicability Year 2026 (“Guidance”) interpreted the IRA in two very faulty ways, which violated the Administrative Procedure Act (APA) and harmed and will continue to harm the company. Opinion at 17. Instead, AstraZeneca alleged harm in four other ways.

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Agency IQ

JUNE 9, 2023

What will the orphan drug market exclusivity haircut mean for industry? provides a 10-year market exclusivity period. The sponsor must show at the time of marketing authorization application (MAA) that the orphan designation criteria are still met. Orphan designation in the E.U. countries examined between 2010 and 2017.

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FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

That means almost certainly no sooner than the second half of 2026. Nor does it allow for full consideration of the implications of removing PE from the monograph and leaving pseudoephedrine as the only oral decongestant active ingredient that can be used in an OTC drug marketed under the monograph.

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FDA Law Blog: Biosimilars

OCTOBER 13, 2024

A recent analysis from NORD showed that among the 39 rare pediatric diseases for which vouchers were awarded, only three had any FDA-approved products on the market before the program’s enactment. No rare pediatric disease vouchers could be awarded even to designated applications after September 30, 2026.

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FDA Law Blog: Biosimilars

JUNE 14, 2023

The striking phrase “valley of death,” is generally understood to refer to the tendency for innovative technologies to fail to reach market, whether due to reimbursement and/or physician or patient preference. up to 225 total products enrolled through FY 2026 and up to 325 total products enrolled through FY 2027).

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