Analysis Of The Trastuzumab Biosimilar Market As Herceptin Exclusivity Nears An End
Posted by | Fuld & Company
Biosimilar Market Analysis
Genentech’s Herceptin (trastuzumab) is a monoclonal antibody for HER2/neu receptors for use in HER2-overexpressing adjuvant and metastatic breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma. Herceptin has successfully cemented itself as a standard of care therapy and represents a multibillion-dollar pillar that centrally supports Roche’s oncology juggernaut, but this is changing. Since its original approval in 1998, Herceptin has enjoyed an exclusivity that has a fast-approaching terminus, with key patent expirations expected before the end of 2019.
Biosimilar competition includes an effort to significantly reduce the financial burden of biologic treatments on the healthcare system. Without direct competition within their treatment spaces, the prices of biologics have aggressively risen to an extent that underscores the need for increased biosimilar competition.
Within the last few years, the FDA has taken steps to approve more biosimilar products and has committed to providing for a competitive landscape. The three latest biosimilars to be approved by the FDA have all been biosimilars to Herceptin. Further, Pfizer’s Trazimera, the most recently approved trastuzumab biosimilar, has sparked intrigue. As a result, Genentech is bracing for Herceptin biosimilar commercial launches in 2019.
To learn more about the the Trastuzumab biosimilar competitive landscape, read the full article at Biolsimilar Development