Biosimilars are biopharmaceutical drugs that are molecularly similar with equivalent therapeutic efficacy and safety as compared to corresponding reference biologics. Biosimilars provide a cost-effective alternate to expensive biologics and expand patient access. With patent expiry of large molecular biologics, biosimilars offer significant cost savings and enable more patients to access lifesaving treatments. Biosimilars are usually approved based on demonstrating analytical, preclinical and clinical similarity to an existing approved biologic.

The global biosimilars market is estimated to be valued at US$ 33.87 Mn in 2024 and is expected to exhibit a CAGR of 5.9% over the forecast period 2024 to 2031.

Key Takeaways

Key players operating in the biosimilars are U.S. Environmental Protection Agency (EPA), European Chemicals Agency (ECHA), Food and Drug Administration (FDA), Ministry of Environment, Forest and Climate Change (India), National Health Commission (China), Canadian Food Inspection Agency (CFIA), National Institute for Health and Welfare (THL) (Finland), Federal Institute for Risk Assessment (BfR) (Germany), National Institute of Food and Drug Safety Evaluation (KFDA) (South Korea), Ministry of Ecology and Environment (China), Environment Agency (United Kingdom), Ministry of Health, Labour and Welfare (Japan), Australian Government Department of Agriculture, Water and the Environment, Health Canada, Ministry of Health (Brazil).

The demand for Biosimilars Market Demand is growing rapidly owing to benefits like cost savings and expanded access to life-saving medicines. Multiple patent expirations of blockbuster biologics create opportunities for market players to launch affordable biosimilar versions. Several key biosimilars like adalimumab, bevacizumab and trastuzumab are seeing increasing adoption rates globally.

Technological advancements have improved characterization techniques, enabled robust comparability assessments and enhanced biosimilar efficacy, safety and immunogenicity profiles. Advanced analytics help establish high similarity to reference products and allay substitution concerns among physicians and patients.

Market Trends

There is an increased focus on expanding access to biosimilars in emerging markets like Asia, Africa and Latin America. Regulatory guidances are being developed to establish approval pathways and regulations in these markets to drive greater uptake. In the US, label extrapolation approvals are accelerating the ability to launch follow-on products across multiple therapeutic indications.

The market sees rising collaborations between originator companies and biosimilar developers to co-develop high volume blockbusters. Various partnerships help share commercialization capabilities and expand patient reaches through combined global footprints.

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