European Pharmaceutical Review

JUNE 19, 2025

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.

Biosimilars 97

Biosimilars Packaging Documentation Drug Development 97

Safe Biologics

NOVEMBER 12, 2023

6 “The Biosimilar Red Tape Elimination Act”, which would prevent the HHS Secretary from requiring switching studies in order for a biosimilar to be deemed “interchangeable” Under U.S. state law, only biosimilars which are interchangeable may be substituted by a pharmacist without contacting the prescriber.

Biosimilars 130

Biosimilars Drug Pricing Packaging Labelling 130

RX Note

DECEMBER 11, 2023

Some medications are supplied in amber (light-protected) vials, while others are stored in the original packaging (foil overwrap or box) until needed. Many medications should be protected from light during storage to avoid degradation.

Packaging 40

Packaging Biosimilars 40

European Pharmaceutical Review

FEBRUARY 22, 2023

The payload is packaged inside a dissolvable needle, loaded within a microsyringe that is attached to a folded, self-inflating balloon. Under the agreement, Celltrion will exclusively supply to Rani the ustekinumab biosimilar drug substance (CT-P43) required for its RT-111 programme. the enteric coating and the capsule dissolve.

Biosimilars 105

Biosimilars Diabetes Immunization Immunity 105

FDA Law Blog: Biosimilars

MARCH 8, 2023

Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. For any major changes, additional time will be granted between the release of the implementation package and production deployment.

Packaging 59

Packaging Communication 59

PharmaTech

JUNE 6, 2025

Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1). This covers new biotechnologically derived protein, glycoprotein, and peptide products as well as biosimilars (3, 4). Biosimilars Market Size | Industry Growth & Forecast Report. Specifications.

Dosage 52

Dosage Drug Development Documentation Biosimilars 52

RX Note

FEBRUARY 23, 2023

Figures - Elemental iron and calcium content?

HIV Treatment and Prevention Agents 58

HIV Treatment and Prevention Agents Community Pharmacies Labelling Chemotherapy 58