Biosimilar drug makers are not required to share their applications and manufacturing processes with the biologics company whose product they are copying, the U.S. Food and Drug Administration says.
Sandoz Pharmaceutical, a division of Novartis, plans to bring a biosimilar of Amgen’s blockbuster chemotherapy product Neupogen to market. But Amgen appealed a federal judge’s decision that cleared the way for Sandoz to launch the product, called Zarxio, and accused Sandoz of skirting the law by refusing to share information about its biosimilar product.
In rejecting Amgen’s petition, the FDA says the procedures for information exchanges are “parallel to, but separate from” the review process. The law does not give the FDA any role in monitoring or certifying the information exchange, the agency said in its March 25 letter to Amgen.
In its appeal, Amgen wants the court to overturn a U.S. District Court for the Northern District of California judge’s March 19 ruling in Amgen v. Sandoz that because the patents protecting Neupogen (filgrastim) have long since expired, Amgen is not entitled to an injunction blocking Sandoz from selling a biosimilar.