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Herceptin, generically known as trastuzumab, is a monoclonal antibody biopharmaceutical originally developed by Genentech (now a part of Roche). It is used primarily for the treatment of HER2-positive breast cancer. Biosimilars are biologic medical products that are highly similar to an already approved reference drug, with no clinically meaningful differences in terms of safety, purity, and potency. The market for Herceptin biosimilars has matured as patents for Herceptin have expired, allowing other biotechnology companies to produce and commercialize biosimilar versions of trastuzumab. The arrival of biosimilars has expanded treatment options and may improve accessibility due to potentially lower costs combined with comparable efficacy and safety profiles. The development and approval of Herceptin biosimilars involve rigorous regulatory pathways to ensure their equivalence to the original biologic in terms of therapeutic effect.
The Herceptin biosimilar market includes several competitors. Notable companies that have developed and marketed biosimilar versions of trastuzumab include Amgen, which collaborated with Allergan (now part of AbbVie) to produce Kanjinti™, Mylan in partnership with Biocon launching Ogivri™, and Samsung Bioepis with its product Ontruzant™. Pfizer's Trazimera™ and Teva Pharmaceutical Industries' Herzuma™ are also players in this space. These companies are at the forefront of expanding Show Less Read more