FDA Greenlights Amgen and Allergan's Herceptin Biosimilar Kanjinti Amid Patent Expiry
The U.S. Food and Drug Administration has approved Kanjinti (trastuzumab-anns), a biosimilar to Roche's Herceptin, developed through a partnership between Amgen and Allergan. The timing coincides with the expiration of Herceptin's main U.S. patent, marking a significant milestone in the oncology therapeutics landscape.
Market Impact and Commercial Significance
Herceptin has been a cornerstone in Roche's portfolio, generating approximately $2.9 billion in U.S. sales last year and nearly $6.8 billion globally. The drug has been off-patent in Europe since 2014, and now the U.S. market is poised for competitive entries.
Amgen and Allergan will face competition from other manufacturers who have already secured FDA approval for their Herceptin biosimilars. Mylan and Biocon received approval in December 2017, followed by Samsung Bioepis in early 2019. Launch dates and pricing strategies for Kanjinti have not yet been announced.
Clinical Applications and Approval Basis
Kanjinti has received approval for all indications of the reference product, including:
- HER2-overexpressing adjuvant breast cancer
- HER2-overexpressing metastatic breast cancer
- HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma
The FDA's approval was based on comprehensive comparative analytical, pharmacokinetic, and clinical data demonstrating Kanjinti's high similarity to Herceptin with no clinically meaningful differences.
Distinctive Clinical Data
In a notable differentiation from competing biosimilars, Amgen and Allergan have conducted specific switching studies. Their data demonstrates that patients previously treated with Herceptin can transition to Kanjinti with comparable safety and immunogenicity profiles after a single transition, potentially providing additional confidence to healthcare providers considering the switch.
Strategic Portfolio Expansion
This approval represents the second biosimilar approved in the U.S. from the Amgen-Allergan collaboration, following their previously approved biosimilar to Roche's Avastin (bevacizumab). Amgen has also secured approval for a biosimilar of AbbVie's Humira (adalimumab), though market entry is delayed until 2023 due to patent protections.