- The European Medicines Agency has accepted for review of the Extension Marketing Authorisation Application for 'Remsima SC', the subcutaneous version of Remsima, the autoimmune disease therapeutic antibody biosimilar of infliximab
, South Korean biopharmaceutical company Celltrion, Inc.
Biosimiiar drugs offer the prospect of alternatives that are more cost-effective than their original versions (known as reference drugs).To distinguish them from their reference drugs, biosimilars must be given different generic names--so, for example, instead of the biological response modifier infliximab
(Remicade), a person with RA may be prescribed its biosimiiar versions: infliximab-dyyb (Inflectra) or infliximab-abda (Renflexis).
5, 2018 (HealthDay News) -- Under Medicare Part D, out-of-pocket costs are similar for infliximab
and its biosimilar infliximab-dyyb, according to a research letter published in the Sept.
AMONG PSORIASIS PATIENTS, treatment with infliximab
was associated with an increased risk of serious infections that led to hospitalization, the use of intravenous antimicrobial therapy, or death, according to a prospective cohort study of cases in the United Kingdom and the Republic of Ireland.
The results confirm non-inferiority compared to infliximab
but could not rule out superiority based on its primary efficacy endpoint, which compared the response difference measured by 20% or greater improvement defined by the American College of Rheumatology Criteria, ACR20, at week 22.
It was reported on Friday that the European Commission has approved Germany-based Sandoz's Zessly (infliximab
) for the treatment of gastroenterological, rheumatological and dermatological diseases.
At symptom onset, she had received infliximab
and azathioprine for >5 years and reported eating undercooked meat; she had not traveled abroad.
and Biocon Ltd.'s Ogivri (trastuzumabdkst), a biosimilar to Herceptin (trastuzumab) from Genentech Inc., and Pfizer Inc.'s Ixifi (infliximab-qbtx), a biosimilar to Remicade (infliximab
) from Janssen Biotech Inc.
In a statement the CMA said: "The CMA has provisionally found that MSD broke competition law by abusing its dominant position through a discount scheme for Remicade that was likely to restrict competition from 'biosimilar' versions of infliximab
that were new to the market.
Amherst, NH, May 02, 2017 --(PR.com)-- BUHLMANN Diagnostics Corp (BDC), BUHLMANN Laboratories AG's North American affiliate is proud to announce that three of its novel products, Quantum Blue[R] Infliximab
Assay, IBDoc[R] and CALEX[R] Cap have received Medical Device Licences from Health Canada and are now commercially available in Canada.
The FDA has approved Samsung Bioepis' Renflexis (infliximab-abda), a biosimilar referencing Remicade (infliximab
), across all eligible indications.