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)
By the year 2020, over $100 billion of biologic pharmaceutical products are expected to lose patent protection and many large monoclonal antibody therapies are coming off patent globally after 2018. 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. The demand is driven by the need for the best valuable treatment, which can often be expensive biologicals. Therefore, the development of biosimilars is encouraged to bring more affordable version of these drugs in to these markets. For this reason, emerging markets have led the way in the development of a number of biosimilar classes, including monoclonal antibodies.
Growth in the biologic markets will also be driven by the increasing global incidents of serious diseases, including cancer and diabetes. Many monoclonal antibodies are used to treat cancer indication and the high cost of biologics will continue to burden healthcare payers worldwide and will lead to greater demands for biosimilars.(3)
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