Biosimilars, Drug Development, Vaccines

Pfizer hits stumbling block on Herceptin rival, but wins ‘breakthrough’ status on MenB vaccine

This morning’s news is a mixed bag for Pfizer $PFE, which reported updates on two different pipeline drugs first thing Monday. One program saw a positive development, while the other was slapped with a setback.

Let’s start with the bad news. The pharma giant said regulators have rejected its trastuzumab biosimilar, which was intended as a cheaper version of Roche’s cancer drug Herceptin. Pfizer placated investors by pointing out that the FDA asked for more technical information to support the application, not for safety or clinical data information.

Roche is likely breathing a quick — if brief — sigh of relief, as competitors are slowly creeping in to divide up its share of the market. Herceptin, used to treat breast cancer along with cancers of the stomach and gastroesophageal junction, is facing rivals like Pfizer’s copycat, Mylan’s newly approved biosimilar OK’ed in December.

Roche isn’t too keen on the competition, considering Herceptin sales bring in billions in revenue for the pharma giant. Roche even launched a legal battle with Pfizer over its Herceptin rival last Novermber, alleging Pfizer’s version infringed on 40 of its patents.

In response to the CRL for its trastuzumab biosim, Pfizer said it plans to work with regulators to address the issue.

Luis Jodar

Pfizer’s other pipeline update involves Trumenba, a vaccine for Meningococcal disease, which is caused by bacteria called Neisseria meningitidis. The vaccine is already approved for young adults between 10 and 25 years old, and now Pfizer is gunning for approval for younger children ages 1 through 9. The company reported Monday that the FDA had granted the company breakthrough therapy status for this age group.

“Despite the occurrence of invasive serogroup B disease in children ages 1 through 9 years, and the potential life-altering and long-term consequences that may result from this uncommon disease, there is no MenB vaccine licensed in the U.S. for this age group,” said Pfizer’s vaccines head Luis Jodar in a statement. “We look forward to working closely with the FDA toward our goal to extend the range of individuals who may benefit from immunization with Trumenba.”


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