Monday, June 16, 2014

Biosimilars at the 2014 EULAR Meeting in Paris

J. Goncalves and colleagues were asking: "IN SEARCH FOR MAB BIOSIMILARITY: HOW TO OVERCOME OBSTACLES?" "The guidelines (of the European Medicines Agency (EMEA)) advocate pre-clinical and clinical testing of biosimilars prior to market authorization, complemented by tailored pharmacovigilance plans. These guidelines provide a valuable base from which to develop in this evolving regulatory environment."

J. Braun taked on: "LATEST UPDATE ON BIOSIMILARS - CHANCES AND RISKS". "EMA and FDA regulations as well as scientific considerations indicate that biosimilarity does not imply interchangeability. In Rheumatology the first biosimilar has recently been approved in Europe a biosimilar to infliximab which has passed all tests and examens and that is produced by a Korean company." It's Remsima by Celltrion.

S.-C. Bae and colleagues presented: "A RANDOMIZED, DOUBLE-BLIND, PHASE 3 EQUIVALENCE TRIAL COMPARING THE ETANERCEPT BIOSIMILAR, HD203, WITH ENBRELR, IN COMBINATION WITH METHOTREXATE (MTX) IN PATIENTS WITH RHEUMATOID ARTHRITIS (RA)". HD203 is a biosimilar of etanercept. Conclusions: "The study met the primary endpoint of demonstrating equivalence in efficacy of HD203 compared with EnbrelR. HD203 was well tolerated, with a safety profile comparable to that of EnbrelR in this population of Korean patients with RA." HD203 is produced by South Korean Hanwha Chemical.

J. Kay and colleagues presented: "A PHASE 3, RANDOMIZED, DOUBLE-BLIND, ACTIVE COMPARATOR STUDY OF THE EFFICACY AND SAFETY OF BOW015, A BIOSIMILAR INFLIXIMAB, IN PATIENTS WITH ACTIVE RHEUMATOID ARTHRITIS ON STABLE METHOTREXATE DOSES". Conclusions: "This is the first clinical trial of a biosimilar IFX to demonstrate and report the kinetics of response to treatment prior to the plateau phase. The comparable proportion of responders at each of these early time points and at the Wk 16 primary endpoint provides convincing evidence of therapeutic equivalence." So there's another infliximab biosimilar at the horizon, produced by Epirus Biopharmaceuticals, Inc.

There have been updates on the PLANETRA study (infliximab biosimilar).

P. Kaur presented the following study: "A RANDOMIZED, SINGLE-BLIND, SINGLE-DOSE, THREE-ARM, PARALLEL GROUP STUDY IN HEALTHY SUBJECTS TO DEMONSTRATE PHARMACOKINETIC EQUIVALENCE OF ABP 501 AND ADALIMUMAB: RESULTS OF COMPARISON WITH ADALIMUMAB (EU)". Conclusions: "Results of this phase 1 study demonstrated bioequivalence of ABP 501 following a single 40-mg SC injection relative to that from a 40-mg SC injection of adalimumab (EU). No new safety signals with ABP 501 treatment were identified."

C. Udata and colleagues presented: "A PHASE I PHARMACOKINETICS TRIAL COMPARING PF-06438179 (A POTENTIAL BIOSIMILAR) AND INFLIXIMAB IN HEALTHY VOLUNTEERS (REFLECTIONS B537-01)". Conclusions: "This study demonstrates PK similarity of PF-06438179 to both infliximab-US and infliximab-EU and of infliximab-EU to infliximab-US. The 3 study drugs were generally safe and well-tolerated in this study." What, if Remicade will be available at a price level of Denusomab? But this study is phase 1!

D. Yin and colleagues presented: "A PHASE I PHARMACOKINETICS TRIAL COMPARING PF-05280586 (A POTENTIAL BIOSIMILAR) AND RITUXIMAB IN SUBJECTS WITH ACTIVE RHEUMATOID ARTHRITIS WITH ACTIVE DISEASE IN TNF FAILURES (REFLECTIONS B328-01)". Conclusions: "This study demonstrates PK similarity of PF-05280586 to both rituximab-US and rituximab-EU and rituximab-EU to rituximab-US. All 3 treatments were generally well tolerated, with a low incidence of treatment-related AEs and discontinuations due to AEs."

S. Narayanan: "RELATIONSHIP BETWEEN THE DURATION OF RHEUMATOLOGY PRACTICE EXPERIENCE AND LIKELIHOOD OF USE AND PERCEPTION TOWARDS BIOSIMILARS IN RHEUMATOID ARTHRITIS ARENA". Conclusions: "Rheumatologists perceptions varied based on their practiceexperience; among those with 10yrs of practice-experience, higher proportion stated being doubtful or less/not likely of prescribing biosimilars to eligible RA patients, and a higher proportion of them cited national treatment guidelines and lack of data from local country/market among key reasons preventing biosimilar use. Conversely, among those with >20yrs of practice experience, a lower proportion cited lack of treatment guidelines and lack of data from local country/market as key reasons preventing biosimilar use." Doesn't this look grim for the producers of biosimilars?

U. Kronthaler and colleagues presented: "PRECLINICAL PK AND SAFETY ASSESSMENT OF THE PROPOSED ADALIMUMAB BIOSIMILAR GP2017, COMPARED TO HUMIRAR". The study has been done in rabbits and in cynomolgus monkeys. Conclusions: "Pre-clinical pharmacokinetic studies are a sensitive means to characterize proposed biosimilars compared to their reference product. Similar AUC and Cmax of GP2017 and HumiraR are shown here in two species, upon single or repeated s.c. administration. ..." Sandoz Biopharmaceuticals, Hexal AG also want a piece of the pie.

F. Berghea and colleagues looked at: "BIOSIMILARS USE IN RHEUMATOLOGY - THE PATIENT PERSPECTIVE". Conclusions: "In few areas (but not everywhere) the patients knowledge about drug (copies) might be deeper than we expect; the socio-economic advantages of biosimilars seems to be fully understood; treating physician should made the choice and assume the responsibilities; in the absence of financial constrictions the idea of a free switch between originals an biosimilars doesnt seem to have many adepts. The study reveals a great need for education and debate in this area in order to fully accommodate the concept of biosimilars in rheumatic patients."

There seems to be a lot going on, but Remsima hasn't knocked on my door, yet.

Biosimilars at the 2013 EULAR Meeting in Madrid
Biosimilars at the 2013 ACR Meeting in San Diego

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