In a major setback to Biocon, rival Amgen and Allergan has launched the biosimilar to cancer drug Herceptin in the US.
The launch hit the Biocon scrip as shares of the Bengaluru-headquartered company dropped 8.17 percent and were trading at Rs 241.55 on the BSE at 3 pm.
Amgen-Allergan duo's Kanjinti was approved by USFDA in June this year for all indications of Herceptin such as the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric cancer.
Herceptin is used in treatment of HER2-positive breast cancers, which account for 25 percent of all breast cancers. Roche made $2.9 billion in 2018 on sales of Herceptin in the US.
Amgen and Allergan have announced that their biosimilar will be priced 15 percent lower than the Roche's Herceptin list price. The companies said that the price could be lower, after discounts and rebates.
Biocon and its partner Mylan received approval for trastuzumab in 2017, becoming the first FDA-approved biosimilar to Herceptin in the US, but didn't launch the drug owing to pending expiration of major patents and a settlement with innovators Genentech and Roche.
Meanwhile, USFDA approved Herceptin biosimilars filed by Celltrion-Teva, Samsung Bioepis, and Pfizer. All of them have settled with Genentech-Roche except Amgen and Allergan.
Genentech has filed a motion for a temporary restraining order and a preliminary injunction against Amgen and Allergan from launching the drug.
The launch dates for biosimilar trastuzumab options have not been publicly disclosed. However, Mylan, when it announced its settlement, said that it anticipated being the first company to launch a biosimilar trastuzumab product in the US, enjoying around six months of exclusivity.
In December 2018, Moneycontrol had reported that Biocon-Mylan will be facing competition in the US from rival drug makers for trastuzumab.
More competition means, more price erosion and companies have to settle for lower margins.
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