Biosimilar
A biosimilar is a biological product that is highly similar to a U.S.-licensed reference biological product notwithstanding minor differences in clinically inactive components, and for which there are no clinically meaningful differences between the biological product and the reference product in terms of the safety, purity, and potency of the product.
Featured Products
Best Practices in Quality and Compliance Management
Price: $70.00
Price: $70.00
Making Sense of FDA's (proposed) Rules for the Development and Approval of Biosimilars
Marketing and sale of biosimilars - FDA guidance documents - Reference Biological Product - Clinical Data - biosimilar approval
Marketing and sale of biosimilars - FDA guidance documents - Reference Biological Product - Clinical Data - biosimilar approval
Delivering Biopharmaceutical Facilities in a Risk Based World: The Role of GEP, QbD, and E2500
Applicable regulatory guidelines - manufacturing of Biopharmaceutical APIs - GMP requirements - cell culture/fermentation - cell bank maintenance and recordkeeping
Applicable regulatory guidelines - manufacturing of Biopharmaceutical APIs - GMP requirements - cell culture/fermentation - cell bank maintenance and recordkeeping
Cleaning Validation Regulations for Biopharmaceuticals: Strategies for Compliance
Biopharmaceuticals vs. drugs - Cleaning assessment and monitoring - Strategies for efficient cleaning validation - Risk assessment - ICH guidelines
Biopharmaceuticals vs. drugs - Cleaning assessment and monitoring - Strategies for efficient cleaning validation - Risk assessment - ICH guidelines
