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Pearce IP BioBlast™: w/e 11 September 2020

by , | Sep 14, 2020

Significant biosimilar activities this week include

08 Sep 20 | The Centre for Biosimilars reports a new study published in Diabetes Spectrum suggests FDA biosimilar naming requirements and switching restrictions cause patients to perceive biosimilars as less similar to reference products. The authors linked the requirement for a biosimilar product to use a four letter suffix and restrictions on pharmacy interchangeability to a diminished interest in biosimilars among patients.

10 Sep 20 | AU | Australia’s Competition and Consumer Commission (ACCC) announced it would not oppose the proposed merger between Mylan NV and Pfizer’s Upjohn Inc division.  Mylan and Upjohn have undertaken to divest three off-patent products (atorvastatin, latanoprost and latanoprost/timolol) in response to competition concerns raised by the ACCC. Aspen has been approved by the ACCC as the purchaser for these products.

10 Sep 20 | Regenxbio announced it has commenced dosing in Ph II trials comparing RGX-314 to monthly ranibizumab injections.  RGX-314 is being developed as a novel, one-time subretinal treatment for wet AMD and diabetic retinopathy.

10 Sep 20 | a new study presented at the Congress of Clinical Rheumatology East indicates that ustekinumab is safe and efficacious in young and elderly patients with psoriatic arthritis.  Researchers reported that there were no clinically meaningful differences in the effectiveness and safety in PsA patients 60 years or older compared with those younger than 60.

10 Sep 20 | Neurology Advisor reported a new study indicates that natalizumab may be more effective than fingolimod or BRACETD in reducing relapses in patients with relapsing-remitting multiple sclerosis.

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