MYL-1401A (adalimumab biosimilar) / Biocon, AbbVie - LARVOL DELTA

Biosimilar uptake still limited in the U.S. (Healio) - "In a virtual presentation for the Interdisciplinary Autoimmune Summit, Jonathan Kay, MD...said the potential risk of an individual switching to a lower-cost biosimilar should be outweighed by the potential benefit of expanded access. 'The availability of biosimilars should decrease the cost of treating patients,' he said. 'Lower price biosimilars introduce market competition and provoke discounts and rebates for bio originators.'....'As a result of this price reduction, as of March 2015, the use of biosimilar infliximab exceeded that of reference infliximab,' Kay said. 'Subsequent use of reference infliximab continued to decrease, while use of biosimilar infliximab continued to increase.'"

Media quote

Biocon: Investor Presentation (Biocon) - Anticipated US/EU filing in chronic plaque psoriasis in FY 2017

Anticipated BLA • Anticipated EU regulatory • Biosimilar • Psoriasis

Biocon set to seek US FDA approval for biosimilars (The Financial Express) - "India’s largest biopharma company, Biocon, is gearing up to enter the regulated markets of the US and the UK with a portfolio of biosimilars....Biocon will be filing for regulatory approvals in these markets in a phased manner during 2016 for four biosimilars — Trastuzumab (to treat breast cancer), Pegfilgrastim (for chemo-induced Neutropenia), Adalimumab (for chronic plaque psoriasis)...biosimilars programs for Trastuzumab, Pegfilgrastim, Adalimumab and Insulin Glargine continue to cross critical milestones in global phase-III clinical trials..."

Anticipated BLA • Anticipated EU regulatory • Biosimilar • Breast Cancer • Psoriasis

Analysis of Pharmacokinetic and Pharmacodynamic Parameters in EU- Versus US-Licensed Reference Biological Products: Are In Vivo Bridging Studies Justified for Biosimilar Development? (PubMed, BioDrugs) - "Our analysis reveals that, in most cases, the reference biological products originated from the EU and those from the USA are almost indistinguishable in terms of PK/PD properties. Additional in vivo bridging studies between reference products from different global regions may not be required if similar physicochemical and structural properties are evident in vitro."

Journal • PK/PD data • Preclinical

Preparation of spherical filler-like ZnFeO/BiMoO surrounded by nanosheets and its Photocatalytic Applications. (PubMed, Environ Technol) - "The degradation results indicated that the ZFO/BMO photocatalyst with 20% ZnFeO content (ZFO/BMO-2) demonstrated highly efficient performance...Furthermore, ZFO/BMO heterojunction composite photocatalyst can be recycled effectively by applying an appropriate external magnetic field. It has important research value in photocatalysis and recycling."

Journal

LONG-TERM SAFETY, IMMUNOGENICITY AND EFFICACY IN RANDOMIZED, DOUBLE-BLIND, AND OPEN-LABEL EXTENSION STUDIES COMPARING FKB327, AN ADALIMUMAB BIOSIMILAR, WITH THE ADALIMUMAB REFERENCE PRODUCT IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS (EULAR 2019) - "...Objectives: To study the long-term safety, immunogenicity and efficacy of FKB327 compared with Adalimumab RP in a randomized double blind (DB) phase 3 study in patients (pts) with active rheumatoid arthritis (RA) inadequately controlled with methotrexate (MTX) and in a subsequent randomized, open-label extension (OLE) study with treatment switching assessed long-term safety, efficacy, PK, and immunogenicity... The safety, immunogenicity, and efficacy of FKB327 were maintained over long-term treatment and after switching between the biosimilar and RP."

Clinical

Immunogenicity of a proposed adalimumab biosimilar, FKB327; and the reference product in patients with rheumatoid arthritis (ECCO-IBD 2019) - "Background The FKB327-002 double-blind (DB) study to compare the efficacy and safety of a candidate adalimumab biosimilar, FKB327; and the reference product (RP) in patients with rheumatoid arthritis also being treated with methotrexate (MTX)—the ARABESC trial—was presented previously...Conclusion The RP and FKB327 showed comparable immunogenicity in long-term administration. Treatment switching from RP to FKB327 or vice versa did not influence either immunogenicity or sustainability of efficacy or safety."

Clinical