United States FDA gets serious about biosimilars

The most significant advances in medical treatments are being made with biological products.  As biological medicines are significantly more expensive than traditional small molecule drugs, upward pressure is being placed on health spending. For example, in the United States, biological medicines accounted for 40% of all prescription drugs spending and 70% of the increase in read more...
Subjects: Patents

Biosimilars: balancing access to affordable medicines with safety

Biological medicines (biologics) are agents derived from a biological source.  As a consequence, they are complex and there is a high degree of variability between molecules of the same active substance.  Biosimilars are medicines that are closely related, pharmaceutically and therapeutically, to their reference biologic.  However, biosimilars are not identical to, and cannot be characterised read more...
Subjects: Uncategorized