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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.

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.”

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 […]

Samsung Etanercept Biosimilar in EMA

In late January, Samsung Bioepis announced that its biosimilar of Amgen’s Enbrel (etanercept), used to treat autoimmune diseases, was accepted for review by EMA. Amgen’s patents on Enbrel set to expire in August 2015.

Japan Approves Lily/BI Insulin Biosimilar

Eli Lilly and Boehringer Ingelheim announced that they had received approval for their insulin glargine biosimilar for Japan in mid-January. The product is a biosimilar of Sanofi’s diabetes drug Lantus. The biosimilar received EC approval in September 2014.

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.

Overview of Comments on EMA Biosimilar Draft Guideline

In December, EMA released an overview of the comments it received on its draft guidance on biosimilars. Comments of note include an accepted comment by the Austrailian Therapeutic Goods Administration (TGA) asking that the phrase “biosimilar” be used to describe “similar biological medicinal Products” and a partly accepted comment by Amgen asking that “posology” be […]

CFDA Releases Draft Guideline for Biosimilars

China’s Center for Drug Evaluation (CDE) published a draft guidance in late October on the approval of biosimilars. The guideline creates a system similar to that of the EU with an approved reference product needed to determine biosimilarity through comparison. The guideline requires that at least three batches of a biosimilar be subject to comparability […]

Final EMA Guideline Update on Biosimilars

In late October, EMA released a final update to its 2005 Similar Biological Medicinal Products guideline. A draft update was released in May 2013 to clarify how biosimilarity is defined regarding safety, efficacy, quality, and biological activity. Changes from the draft to the final include clarification on the need for similarity to the reference product […]
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