Release Date: 29-Aug-2023
The US FDA has taken a lead in the global pharmaceutical market with its precise and favorable policies that has often allowed the advent of new drug classes. One of these is bispecific antibodies, which work using the same concept as monoclonal antibodies but exert enhanced therapeutic effects. Till date, the FDA has approved 11 bispecific antibodies for marketing in the US that span indications like cancer and blood and eye disorders. In the year 2022, the FDA had approved 4 bispecific antibodies; the agency was able to maintain this number in 2023 as well, highlighting its itinerary of bringing novel therapeutics to the market for patients in need.
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Bispecific antibodies constitute a sizeable portion of the US pharmaceutical market, and the cumulative sales of this drug class have been increasing every year owing to market launches of new bispecific drugs every year. They have shown potential in enhancing the treatment outcomes in cancer patients; hence, majority of bispecific antibodies in the US are approved for cancer indications, while several more are under development for both solid and hematological cancers. With the FDA’s guidance, converging with the efforts of pharmaceutical companies and medical institutions and universities, bispecific antibodies are on their way to become one of the largest drugs classes in the US for cancer treatment.