Pfizer’s cancer drug hits FDA roadblock

With the loss of patent protection for its flagship drugs – Lipitor and Viagra – drugmaker Pfizer (PFE) has been struggling to revive its sales. The pharma giant has been investing heavily in biosimilars and has been on a look for new growth avenues, but it is not immune to setbacks. The company hit a roadblock after the US Food and Drug Administration turned away the company’s biosimilar version of Herceptin – Roche’s blockbuster cancer drug.

According to the estimates provided by Forbes last year, Roche’s oncology business – with key drugs namely Avastin, Herceptin, and Rituxan – generates nearly 50% of the total revenue. A cheaper version of these drugs is expected to take a bite out of the company’s cancer sales in 2020.

Roche – the Swiss drugmaker – is under pressure as Herceptin is near to losing its patent protection. The fear of intensifying competition forced Roche to sue Pfizer last year to block the latter’s biosimilar version of Herceptin. The lawsuit filed by Roche claims that Pfizer would violate nearly 40 of its patents with a biosimilar version of the breast cancer treatment.

The company hit a roadblock after the US Food and Drug Administration turned away the company’s biosimilar version of Herceptin – Roche’s blockbuster cancer drug.

But now that the FDA has issued Complete Response Letter (CRL) seeking additional technical information, Roche probably breathed a sigh of relief. Pfizer conciliated its investors stating the FDA did not seek information on safety and clinical data.

If Pfizer wins the FDA approval, it will have to compete against Mylan (MYL). Last year Mylan along with Biocon, its partner, got an OKAY from the FDA for a biosimilar version of Herceptin – Ogivri.

Pfizer has in the past encountered several challenges over biosimilars. The company’s attempt at producing a biosimilar version of Epogen – Amgen’s (AMGN) anemia drug – was flatly rejected by the FDA. The latest FDA rejection, however, coincided with Pfizer winning the approval from the FDA for a breakthrough therapy status for MenB vaccine in children.