European Pharmaceutical Review

JANUARY 2, 2024

Over the past several years, the pharmaceutical industry has faced challenges regarding quality assurance in drug development, the author asserted. It also lowers the regulatory burden too, the paper reported. [In The team examined the European Public Assessment Report (EPAR) for the QbD approach. concluded. “To

Drug Development 105

Drug Development Biosimilars Documentation 105

Safe Biologics

SEPTEMBER 12, 2023

ASBM & GaBI Webinar on Medicare Price Negotiation Examines Impact on Innovation, Patient Access On July 26th, ASBM and the Generics and Biosimilars Initiative (GaBI) hosted a webinar entitled MEDICARE DRUG PRICE NEGOTIATIONS: Impact on Healthcare Development and Patient Access to Medicines.

Biosimilars 130

Biosimilars Drug Pricing Drug Development 130

Express Pharma

SEPTEMBER 6, 2023

Known as biosimilars, these biopharma products are highly similar to innovator products and have no clinically meaningful dissimilarities, especially in terms of efficacy, safety or quality. Indian pharma players could play a key role in positioning biosimilars as superior products to costly biologics.

Insurance Coverage and Processing 59

Insurance Coverage and Processing Biosimilars Generic Medicine Drug Pricing 59

European Pharmaceutical Review

DECEMBER 22, 2022

4 One of the first activities to fall onto the critical path, and potentially cause substantial drug development delays, is clone selection. Rapid development of clonal cell lines is required to facilitate material manufacture for non-clinical toxicological studies, and master cell bank (MCB) creation to enable clinical manufacture.

Biosimilars 98

Biosimilars Immunity Immunization Drug Development 98