Biosimilars are biological medicines highly similar to an approved original biologic. They provide an affordable alternative, enhancing patient access to...
Biosimilars are biological medicines highly similar to an already approved original (reference) biological product. They have no clinically meaningful differences in terms of safety, purity, and potency from the reference product.
Generic drugs are identical, small-molecule chemical copies of brand-name drugs. Biosimilars, however, are large, complex biological products that are 'highly similar' to their reference biologics, but not identical due to their intricate biological nature and manufacturing processes.
Yes. Regulatory bodies like the FDA and EMA conduct extensive reviews requiring comprehensive data to ensure biosimilars demonstrate comparable efficacy, safety, and quality to their reference biological products before approval.
Biosimilars increase patient access to vital treatments by offering more affordable alternatives to expensive biologics. They also reduce healthcare costs, drive competition in the pharmaceutical market, and contribute to overall healthcare sustainability.