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.

Biosimilars 59

Biosimilars Dosage Packaging 59

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. The court found numerous flaws with this argument.

Dosage 64

Dosage Drug Pricing 64

FDA Law Blog: Biosimilars

OCTOBER 12, 2023

Taking a step back, a Suitability Petition is used when an ANDA applicant wants to submit an ANDA that differs from its Reference Listed Drug in strength, dosage form, route of administration, or, in the case of a combination drug, active ingredient. Under 21 C.F.R.

Dosage 59

Dosage 59

FDA Law Blog: Biosimilars

NOVEMBER 11, 2024

That means almost certainly no sooner than the second half of 2026. As dictated by the process provided for in the 2020 CARES Act, FDA announced issuance of the proposed order in a Federal Register notice and published the proposed order itself on FDA’s website.

Pharmacy Management 111

Pharmacy Management Dosage Documentation 111