Allergan files ANDA for generic version of Celgene’s breast cancer treatment

pharmafile | March 18, 2016 | News story | Business Services, Medical Communications, Sales and Marketing |  Abraxane, Allergan, Celgene, breast cancer, generic 

Allergan (NYSE: AGN) said it is seeking regulatory approval for a generic version of biotech firm Celgene’s (Nasdaq: CELG) breast cancer drug. 

The company said it has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) for the generic version of the chemotherapy drug, Abraxane. 

Allergan believes it is a first applicant to file an ANDA for the generic version of Abraxane and, should it’s ANDA be approved, may be entitled to 180 days of generic market exclusivity. 

For the 12 months ending January 31, 2016, Abraxane had total US sales of about $683 million, according to IMS Health data. 

Abraxane is indicated to treat metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. It is also used for locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, and metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. 

In November, Allergan and US drug major Pfizer (NYSE: PFE) confirmed $160 billion merger to create the largest pharma company globally.

Celgene said it is assessing the notice and intends to “vigorously defend its extensive intellectual property rights relating to Abraxane.”

Anjali Shukla