News

This week, JHL Biotech announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has granted ithe company a positive Scientific Advice to begin a phase 3 clinical trial of its potential rituximab biosimilar, JHL1101. 
Vermont and Connecticut have recently signed laws providing a pathway for and regulations around the substitution of interchangeable biosimilars for the reference biologic product at the pharmacy level. 
Transitioning from reference adalimumab (Humira) to Amgen’s FDA- and EU-approved adalimumab biosimilar ABP 501 (Amgevita) was not associated with increased immunogenicity over an observation period of 72 weeks in patients with rheumatoid arthritis, according to the results of a study presented at the European Congress of Rheumatology.
The Center for Biosimilars® recaps the top 5 articles for the week of July 9, 2018.
Earlier this month, US Senators Chuck Grassley, R-Iowa, and Amy Klobuchar, D-Minnesota, sent a letter to Federal Trade Commission (FTC) Chairman Joseph Simons urging the FTC to “examine whether makers of biologic medicines are using strategies like ‘pay-for-delay’ to hinder or delay biosimilars from entering the market.”
Prestige BioPharma and Alvogen have recently announced that they have entered into an exclusive partnership for the commercialization of Prestige BioPharma’s trastuzumab biosimilarin Central and Eastern Europe. 
Amgen recently announced top-line results from a phase 3 clinical trial that sought to evaluate the safety and efficacy of its proposed infliximab biosimilar, ABP 710, compared with the reference product (Remicade) in patients with moderate-to-severe rheumatoid arthritis (RA). 
Italian researchers report that 72% of their trial participants being treated for psoriatic arthritis achieved sustained remission with ETN 25 mg biweekly, which was maintained a year after treatment initiation.
Lupin recently announced that it has entered into a partnership agreement with Mylan to commercialize its proposed etanercept (Enbrel) biosimilar.
The FDA recently released a draft guidance document that provided an overview of the content and format of information sponsors should include in the “Indications and Usage” section of a drug label for drugs and biologics. 
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