Categories Other Industries

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.

 

Image courtesy : Norbert Nagel, Wikimedia Commons

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.

Most Popular

Should investors worry about Micron’s (MU) weak Q4 results and guidance?

The semiconductor industry is a rapidly growing business segment that currently thrives on the digital transformation wave. The demand for memory chips and other semiconductor products increased over the years,

What has Bed Bath & Beyond (BBBY) outlined for this fiscal year?

Shares of Bed Bath & Beyond (NASDAQ: BBBY) were up on Friday, a day after the company delivered disappointing results for the second quarter of 2022. The company reported a

NKE Earnings: Highlights of Nike’s Q1 2023 results

Nike, Inc. (NYSE: NKE) has reported a decrease in net profit for the first quarter of 2023, despite a modest increase in revenues. The company's stock suffered a big loss

Tags

Add Comment
Loading...
Cancel
Viewing Highlight
Loading...
Highlight
Close
Top