Amgen/Allergan Get FDA Nod for Herceptin Biosimilar Kanjinti

Amgen, Inc. AMGN and its biosimilar collaboration partner, Allergan AGN announced that the FDA has approved Kanjinti (trastuzumab-anns), their biosimilar of Roche’s RHHBY breast cancer drug, Herceptin (trastuzumab).

Kanjinti received approval for all approved indications of the reference product, Herceptin — HER2 overexpressing adjuvant and metastatic breast cancer, and HER2 overexpressing metastatic gastric cancer or gastroesophageal junction adenocarcinoma. Please note that the biologics license application (“BLA”) had received complete response letter from the FDA in May 2018. We remind investors that the biosimilar drug is already available in EU since last year.

Since December last year, the FDA has approved four biosimilar version of Herceptin including Kanjinti. Rest of the biosimilar drugs are Pfizer’s PFE Trazimera, Merck/Samsung Bioepis’ Ontruzant and Celltrion/Teva Pharmaceutical’s, Herzuma.

Amgen’s shares have declined 9.3% this year so far against an increase of 1.9% for the industry.


Amgen is focusing on developing biosimilar versions of popular drugs, which offers significant growth opportunity.

Kanjinti is the third biosimilar from Amgen’s portfolio to receive approval in the United States. The company now has three approved biosimilar drugs in the United States and Europe — Amjevita, Mvasi, Kanjinti. Currently, Amgen has 10 biosimilar products in its portfolio. A biosimilar version of Johnson and Johnson/Merck’s Remicade (ABP 710) is under review in the United States and EU.

Amgen has a collaboration agreement with Allergan for the worldwide development and commercialization of four oncology antibody biosimilars. Kanjinti is the second drug to receive FDA approval under this agreement. Mvasi, biosimilar version of another Roche’s cancer drug, Avastin, has also been approved by the FDA but not yet launched. A biosimilar version of Roche’s Rituxan is in late-stage development for non-Hodgkin’s lymphoma and rheumatoid arthritis.

Meanwhile, several Amgen’s key drugs are facing rising competition from biosimilars. Sales of products like Neupogen and Neulasta have already been adversely impacted. Several generic versions of Neupogen have been launched. Mylan and Coherus launched biosimilars of Neulasta in the United States in mid 2018/early 2019. More biosimilars of Neulasta are expected to be launched in 2019. Other drugs set to face generic competition include Enbrel, Aranesp and Epogen.

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Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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