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New Biosimilar Manufacturers Coalition

In early May, a coalition of 11 leading companies involved in the development and manufacturing of biopharmaceuticals and biosimilar medicines announced the formation of the “Biosimilars Forum” – the first nonprofit organization dedicated to expanding patient access to biosimilars in the U.S. The founding members of the Biosimilars Forum include Actavis, Amgen, Boehringer Ingelheim, Coherus […]

FDA’s First Biosimilar Approval

In early March, FDA announced its first approval of a biosimilar – Sandoz’ Zarxio. The review of the biosimilar version of Amgen’s Neupogen (filgrastim) took nine months. The approval was not accompanied with an “interchangeable” designation.

Public Hearing on GDUFA Regulatory Science Initiatives

FDA will be holding a public hearing on June 5 to discuss regulatory science initiatives related to the Generic Drug User Fee Act (GDUFA). The hearing is designed to obtain input from industry on the identification of regulatory science priorities for FY 2016.

Advisory Meeting on Celltrion’s Infliximab Biosimilar Delayed

A meeting to evaluate Celltrion’s biosimilar infliximab, scheduled for March 17, has been delayed. The product is a biosimilar of J&J’s Remicade and is the first biosimilar mAb filed in the US. No new date has been set. The reason for the delay was given as “information requests pending with the sponsor.”

Comments Requested on Licensing Provisions for Biosimilar Applications

In early February, FDA requested comments on the licensing provisions and interchangeability data required for biosimilar applications. The notice states that biosimilar manufacturers are expected to have the same clinical results and no greater risk than the reference product used.

Australia Changes Biosimilar Naming

In late January, Australia’s TGA made changes to its biosimilar naming convention in order to better match those used internationally. The agency’s former naming convention was based on WHO’s INN biosimilar identifier combined with the Australian biological name (ABN). TGA is reviewing its naming policy following a July 2014 WHO draft policy on biological qualifiers. […]

Biosimilar Working Party Plan

EMA’s Biosimilar Medicinal Products Working Party (BMWP) announced its 2015 work plan in late January. The plan lists meetings to be held March 3-4 and October 27-29, activities with external parties, and guidelines that are anticipated to be updated. In the first quarter of 2015 the group anticipates updating the guideline on products containing recombinant […]

EMA to Share Generics Assessments

EMA announced in mid-January that it would share its assessments of applications for generic drugs with other regulatory agencies. The first phase of its “International Generic Drug Regulators Pilot,” started in July 2014, involves the EU, Australia, Canada, Chinese Taipei, and Switzerland. Initially ten applications for generics will be shared.

Global Excipient Databases Are Advancing That Will Fill Content and Functionality Gaps in Existing Regulatory Efforts and Further Industry/Regulator Communication

FDA is working with industry, academia, and other regulators globally on major information management initiatives intended to help industry and regulators communicate about pharmaceutical excipients and fill gaps in existing regulatory database efforts, such as the agency’s Inactive Ingredients Database (IID)....

Biosimilar Filgrastim Recommended for Approval

FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended approval of Sandoz’s biosimilar filgrastim in the US. The product is a biosimilar of Amgen’s Neupogen. Sandoz’s filgrastim would become the first biosimilar approved in the US.
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