FDA Approves Ontruzant, Samsung Bioepis and Merck's Biosimilar to Herceptin for Cancer Treatment
Key Insights
The FDA has granted approval for Ontruzant, a biosimilar version of Roche's Herceptin, developed by Samsung Bioepis (search) and to be marketed by Merck & Co (search) in the United States.
The biosimilar is approved for multiple indications including HER2 (search)-positive breast cancer (search) and metastatic gastric cancer (search), offering a potentially more affordable treatment option.
This marks Samsung Bioepis (search)' first FDA-approved oncology biosimilar, joining other competitors like Celltrion/Teva (search) and Mylan in the Herceptin biosimilar market.
The U.S. Food and Drug Administration has approved Ontruzant, a biosimilar to Roche's blockbuster cancer drug Herceptin, developed through a collaboration between Samsung Bioepis (search) and Merck & Co (search). The approval comes ahead of Herceptin's U.S. patent expiration in June, marking a significant milestone in expanding access to trastuzumab-based therapy.
Comprehensive Approval Across Multiple Indications
The FDA has granted Ontruzant approval across all eligible indications, including:
- Adjuvant treatment of HER2-overexpressing breast cancer
- Metastatic breast cancer
- Metastatic gastric cancer or gastroesophageal junction adenocarcinoma in previously untreated patients
The regulatory decision follows rigorous evaluation confirming no clinically meaningful differences in safety and efficacy compared to the reference product.
Market Impact and Commercial Strategy
Under the partnership agreement, Merck & Co (search) will handle the marketing and distribution of Ontruzant in the United States. This entry into the market could significantly impact the oncology landscape, considering Herceptin's substantial market presence with worldwide sales of $7 billion in 2017, including $2.7 billion from U.S. sales alone.
Samsung Bioepis (search)' Senior Vice President and Commercial Division Head, Sang-Jin Pak, emphasized the potential impact on healthcare costs: "For many cancer patients in the U.S., battling cancer has not only been a health issue but a considerable financial burden brought on by cancer treatment. Biosimilars are intended to be lower cost, high-quality treatment options that have the potential to alleviate such burden."
Competitive Landscape
Ontruzant enters a growing market for Herceptin biosimilars, following recent approvals for competitors including:
- Celltrion and Teva's Herzuma
- Mylan's biosimilar version (launch date pending due to agreement with Roche)
Manufacturing and Development Considerations
Unlike traditional generic drugs, biosimilars are produced using sophisticated cell technology, requiring extensive development and manufacturing processes. While this complexity results in higher production costs compared to small molecule generics, biosimilars still offer significant potential savings for healthcare systems and patients.
The approval of Ontruzant represents a significant advancement in the oncology biosimilar landscape, potentially improving access to critical cancer treatments while helping to address the financial challenges faced by patients requiring these therapies.