Biosimilars are a class of biological medicines that are designed to mimic existing and approved biological medicines, known as reference products. These products are made from large complex molecules derived from living cells or organisms and manufactured under controlled settings. They include gene therapies, stem cell therapies, and monoclonal antibodies and are often more effective than chemically synthesized medicines in treating serious conditions like cancer and autoimmune diseases.
In 2010, the FDA began regulating biosimilars, enabling their commercialization after the reference product's patent expired. To meet FDA approval, biosimilars must satisfy two key criteria—they must be functionally and structurally similar to the reference product and must not differ clinically from the reference product in any meaningful way. Biosimilars offer a lower-cost alternative to original biological products. They also provide patients with more options while increasing competition in the pharmaceutical industry.
Biosimilar players can be broadly categorized into pure play and diversified drug developers, specialized testing and technology providers, and contract development and manufacturing providers.
Note: Additional sections (market sizing, detailed overview, incumbents, etc.) can be provided on request.