US biopharma and Chinese generics firm will co-develop medicines from Amgen’s pipeline focused on inflammation and oncology
The US biopharmaceutical firm Amgen and Chinese generic drug maker Simcere Pharmaceutical plan to co-develop and commercialise four biosimilars in China.
Amgen will be responsible for co-development, marketing approval applications and manufacturing of the biosimilars, while Simcere will be in charge of distribution and commercialisation activities in China.
Details of the four medications have not been disclosed, other than that they are drawn from Amgen’s existing cancer and inflammation portfolio. The US Food and Drug Administration (FDA) approved Amgen’s version of Abbvie’s arthritis and inflammation antibody Humira (adalimumab). However, its launch was delayed by a patent infringement lawsuit from AbbVie, which the companies have now settled via a licensing agreement.
US approval of biosimilars is gaining momentum: earlier this month the FDA approved Amgen and Allergan’s version of Roche’s cancer treatment Avastin (bevacizumab). The FDA is currently considering Mylan and Biocon’s version of Roche’s breast cancer drug Herceptin (trastuzumab), after an advisory committee recommended it for approval. A second Herceptin biosimilar, from Teva and Celltrion, is also under review.
But legal battles continue to stall introduction of biosimilars in the US. Pfizer is suing Johnson & Johnson, claiming its subsidiary Janssen has used anticompetitive tactics and contracts to deny patients access to Pfizer’s Inflectra, an FDA-approved biosimilar of Janssen’s autoimmune disease treatment Remicade (infliximab)