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 authorised and commercialised, 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.
A similar biological medicinal product and its reference medicinal product are expected to have the same safety and efficacy profile and are generally used to treat the same conditions. (1)
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.
"Approved biosimilars are as safe and efficient as the originator biologicals."(2)
Biological pharmaceutical agents will continue to outpace overall pharma spending growth. In 2017, the value share of biologics is estimated at Bn 220 exceeding 20% of the value of the total pharmaceutical market. By the year 2020, over $100 billion of biologic pharmaceutical products are expected to have lost patent protection. Many of these products are among the highest selling drugs in the world today. Unique Icelandic IP environment enables Alvotech to launch products anywhere in the world the moment the patents expire in any given region or country.
Demand for biosimilar is strong in both developed and emerging markets driven by the ever-increasing need for cost effective generic treatment alternatives to high cost biopharmaceuticals Without increased access to generic alternatives high priced biologics will continue to burden healthcare payers worldwide and prevent access to life-saving and life-altering medicines across the globe. (3)