Kelly Davio

March 13, 2019

Drug maker Alvotech announced today that it has begun enrollment for its phase 3 clinical study of AVT02, a proposed adalimumab biosimilar referencing Humira. Alvotech says that it has enrolled its first patient, and it plans to enroll approximately 400 total participants at 30 European sites in the study of AVT02 versus the reference product in patients with chronic plaque psoriasis.

March 13, 2019

The FDA has issued a new Form 483 to Biocon over the Bangalore facility where it produces its biosimilars. The document makes 2 inspection observations that stem from an inspection carried out in February 2019.

March 12, 2019

Among the data presented to regulators for the product’s approval were those arising from a phase 1 pharmacokinetic and pharmacodynamic study in healthy volunteers and those from 2 phase 3 studies in patients with breast cancer undergoing chemotherapy.

March 11, 2019

Only 49.0% of prescribers reported that they use biosimilars in routine clinical practice, with more respondents from the Asia–Pacific region (56.3%) using these agents than their European counterparts (46.5%). The rate of use in the European group was lowest among UK prescribers (31.3%). A total of 24.1% reported that they do not use biosimilars in practice due to either a lack of approval or a lack of reimbursement in their respective countries.

March 11, 2019

This month, US District Judge William Alsup granted biologic developer Genentech some relief in its civil case against biosimilar developer JHL.

March 08, 2019

After the FDA published updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars, biosimilar developers were quick to voice their concerns. According to industry, the FDA’s decision to require 4-letter, nonmeaningful suffixes for biosimilars, interchangeable biosimilars, and new biologics—but not already approved biologics—could seriously hinder biosimilar uptake.

March 08, 2019

During this week’s 14th Congress of the European Crohn’s and Colitis Organisation, multiple research teams reported on efforts to better understand the factors that impact adalimumab therapy in patients with inflammatory bowel disease (IBD).

March 07, 2019

The FDA has issued an updated draft guidance on the naming of biologics, biosimilars, and interchangeable biosimilars.

March 07, 2019

Celltrion, maker of biosimilar infliximab CT-P13 (Remsima, Inflectra), has recently submitted an application to the European Medicines Agency for a subcutaneous formulation of the biosimilar.

March 06, 2019

The advent of biosimilar adalimumab in the European Union was among the most eagerly awaited events for biosimilar stakeholders in 2018. During this week’s European Crohn’s and Colitis Organisation’s 14th Congress, held in Copenhagen, Denmark, research teams are presenting findings concerning antidrug antibody (ADA) development related to adalimumab and therapeutic drug monitoring (TDM) of one of those adalimumab biosimilars: Amgen’s ABP 501, sold in the European Union as Amgevita.