BioSimilars: FDA Panel Overwhelming Recommends Approval of Remicade BioSimilar, Congress Asks Tough Questions of FDA and CMS

Yesterday an FDA Advisory panel overwhelmingly recommended the Celltrion/Pfizer biosimilar Remsima 21-3 for approval for all the clinical indications for Jannsen's Remicade including (RA, AS, PsA, PsO, adult CD, pediatric CD, adult UC). The discussions were straight forward outlining just how similar the two products really were. This is only the second biosimilar to get an advisory committee. But given the FDA's staff enthusiastic analysis of the clinical program and the advisory panels whole hearted validation for all the questions before the panel we can expect to see the flow of biosimilar applications and approvals start to accelerate. Congress While Martin Shkerli was busy making fun of congress for discussing his Wu Tang album at the Government Oversight committee hearing. The real work to reduce drug prices was being held at the same time in the Committee on Energy and Commerce Subcommittee on Health, entitled, "Examining Implementation of the Biologics Price Competition and Innovation Act." The hearing was an opportunity for the Congress and the general public to get an update from the Food and Drug Administration (FDA) on the regulation and approval of biosimilars, as well as an update from the Centers for Medicare and Medicaid Services (CMS) on the recent reimbursement policy. In 2010, the Biologics Price Competition and Innovation Act was enacted to establish a new and abbreviated approval pathway at the FDA for biological products that are determined to ...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs