Clinical Trials For Oncology Biosimilars: Which Indications Can We Expect Approvals? Asks GlobalData

Biosimilars have become a hot topic over the past few years and their development has been gaining significant momentum recently with the first approvals in oncology won in 2017. According to GlobalData, a leading data and analytics company, this topic will gain significant attention in the year ahead.

While many questions regarding pricing, reimbursement, uptake, and acceptance among patients and oncologists are yet to be answered, the FDA and EMA guidelines on product development and approval have made significant progress in recent years.

GlobalData assessed the indications for Phase III trials underway for the four most advanced biosimilar products in oncology: bevacizumab (biosimilar to Roche’s Avastin), cetuximab (biosimilar to Eli Lilly’s Erbitux), rituximab (biosimilar to Roche’s Rituxan), and trastuzumab (biosimilar to Roche’s Herceptin).

Heather Leach. PhD, Associate Director for Oncology and Hematology at GlobalData, commented, “The approval of a biosimilar is based heavily upon analytical data to establish similarity to a reference product. These products also require clinical testing in a Phase III trial to establish safety, efficacy, and immunogenicity. While some products are studied in multiple indications, many are conducted in only one or two key indications. Although evidence is likely to be strong for some indications with high incidence numbers, such as NSCLC and CRC, oncologists treating more rare conditions will need to weigh their comfort level with extrapolation against the affordability of biosimilars.’’

Rituxan is approved for chronic lymphocytic leukemia (CLL) and Non-Hodgkin’s lymphoma (NHL). However, most Phase III development underway for biosimilars is in NHL, diffuse large B-cell lymphoma (DLBCL, a lymphoma that includes NHL), and various other rare forms of lymphoma. As expected for trastuzumab biosimilars, most development is for breast cancer. Herceptin is approved for HER2-overexpressing breast cancer or HER2-overexpressing gastroesophageal junction (GEJ) adenocarcinoma, however, sales are mostly garnered from breast cancer. This represents a much larger patient population than GEJ cancers. For cetuximab biosimilars, very few Phase III trials are currently underway with only two Phase III trials, one in recurrent head and neck squamous cell carcinoma (HNSCC), and the other in unspecified cancers.

Leach added, ‘‘As more trials are launched, GlobalData predicts that CRC will be an additional indication of interest for biosimilar companies looking to develop a cetuximab biosimilar, with Erbitux sales at nearly $1.0B in 2017 for the 7MM in CRC alone.’’

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