Drug Update: November 2016 Issue 2

New Drug Launch: Inflectra Expected to Become Available in Late November

The second biosimilar approved in the United States, Inflectra® (infliximab-dyyb), is expected to become commercially available in late November 2016. Inflectra is a biosimilar to reference product Remicade® (infliximab) and is approved for most of the reference product’s indications. Pfizer is responsible for marketing of the biosimilar in the U.S. and has announced the biosimilar will be priced at a 15% discount to the current wholesale acquisition cost (WAC) of Remicade. The manufacturer of Remicade, Johnson & Johnson, has stated sales of the biosimilar would be considered an “at risk launch” as patent litigation between the two companies has not been resolved. Read more

Drug Update: November 2016 Issue 1

New Drug Approval: FDA Grants Accelerated Approval to New Cancer Drug

 Last month, the U.S. Food and Drug Administration (FDA) granted accelerated approval to Lartruvo® (olaratumab) to treat adults with certain types of soft tissue sarcoma (STS). Lartruvo is approved for use in combination with doxorubicin for patients with STS who cannot be cured with radiation or surgery and who have a type of STS for which treatment with an anthracycline chemotherapy (e.g., doxorubicin) is appropriate. Lartruvo was granted accelerated approval and therefore continued approval may require demonstration of clinical benefit in confirmatory trials. Read more