Biosimilars are approved biologics with comparable quality, safety and efficacy to a reference product. Biosimilar medicinal products may offer a less-costly alternative to existing biological medicinal products that have lost their exclusivity rights Alvotech biosimilars are developed in order to meet the stringent regulatory pathways in highly regulated markets such as the EU, US, Japan, Canada and Australia.
Biosimilar medicinal products have been approved by regulatory authorities in highly regulated markets and have been used safely by patients since 2006. Their market share has been growing at different rates across the world markets.
A similar biological medicinal product, also known as a biosimilar, is a product that is similar to a biological medicine that has already been authorized and commercialized, the so-called 'reference medicinal product'. Biologics are typically based on naturally existing proteins in the human body and are produced using bioengineered living cells such as mammalian or bacterial cells. They can consist of relatively small molecules such as human insulin or erythropoietin, or complex molecules such as monoclonal antibodies.
Biologics are large molecules compared to most traditional, chemically synthesized medicines, therefore the manufacturing process for biologic medicines is generally more complex than manufacturing processes for chemical drugs.