Pfizer to launch second-ever biosimilar in the US

Pfizer announced yesterday that it will launch a biosimilar of one of Johnson & Johnson’s (J&J) best-selling drugs, Remicade (infliximab), which brought in a total of $9.2 billion in revenue last year.

The biosimilar will be marketed under the name Inflectra (infliximab-dyyb) and will be available for patients in late November at a 15% discount.

Inflectra, a treatment for paediatric patients with moderate to severe Crohn’s disease, will be the first biosimilar monoclonal antibody—and only the second biosimilar—to be available in the US.

The launch will happen while there is ongoing litigation between Pfizer and J&J in a dispute centring on the validity of a Remicade patent.

The US District Court for the District of Massachusetts ruled in August that the patent was invalid, but J&J has appealed against the decision.

J&J told LSIPR: "We will continue to defend our intellectual property rights relating to our innovative medicines, and consider this commercial launch of the infliximab biosimilar to be an at-risk launch."

The company added: "It is important to note that the infliximab biosimilar is not approved for interchangeability, which is a higher FDA standard."