Friday , June 22 2018
Home / Biosimilars

Biosimilars

Celltrion Completes Resubmission to FDA for CT-P6, a Proposed Trastuzumab Biosimilar

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P6, a proposed mAb biosimilar to Herceptin® (trastuzumab). Celltrion submitted its abbreviated Biologics License Applications (aBLAs) for CT-P10 and CT-P6 to the FDA in April and May of last …

Read More »

Sandoz Presents New Long-Term and Switching Data for Biosimilars Zessly and Erelzi in Rheumatoid Arthritis

Holzkirchen, June 15, 2018 – Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced the presentation of two long-term, Phase III studies: one each for biosimilar Zessly®(infliximab)[4],[5] and biosimilar Erelzi® (etanercept).[6],[7] Research from the 54-week REFLECTIONS B537-02 study of Zessly and the 48-week EQUIRA study of Erelzi …

Read More »

Samsung Bioepis and Biogen Announce Pooled Analysis Results of Anti-TNF Biosimilars BENEPALI, FLIXABI and IMRALDI

INCHEON, Korea & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Samsung Bioepis Co., Ltd. and Biogen (Nasdaq:BIIB) today announced pooled analysis results of three anti-tumor necrosis factor (anti-TNF) biosimilars – BENEPALI™ (SB4, etanercept biosimilar), FLIXABI™ (SB2, infliximab biosimilar), and IMRALDI™ (SB5, adalimumab biosimilar) – which will be presented at the Annual European Congress of Rheumatology (EULAR 2018) …

Read More »

Celltrion Showcases Promising Preliminary Results for New Subcutaneous Formulation of CT-P13 in Rheumatoid Arthritis

AMSTERDAM–(BUSINESS WIRE)–New data presented at the Annual European Congress of Rheumatology (EULAR 2018) show that the subcutaneous (SC) formulation of CT-P13 is comparable in terms of efficacy and safety with the intravenous (IV) formulation of CT-P13 for the treatment of patients with rheumatoid arthritis (RA) up to week 30. The …

Read More »

FDA Approves Mylan and Biocon’s Fulphila, the First Biosimilar to Neulasta

HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, June 4, 2018/PRNewswire/ — Mylan N.V. (NASDAQ: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Fulphila™ (pegfilgrastim-jmbd), a biosimilar to Neulasta® (pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever …

Read More »

Celltrion Completes Resubmission for Biosimilar Candidate CT-P10 to FDA for Review

INCHEON, South Korea–(BUSINESS WIRE)–Celltrion (KRX:068270) has made a resubmission to the FDA (U.S. Food and Drug Administration) to obtain its marketing approval for CT-P10 (rituximab), a proposed mAb biosimilar to Rituxan®. Additionally, Celltrion plans on making a resubmission for the approval of CT-P6, a proposed biosimilar to Herceptin® in June. In accordance …

Read More »

Biosimilars Could Facilitate Early Access to Life Changing Biological Treatments for Patients

BALTIMORE–(BUSINESS WIRE)–At the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 23rd Annual International Meeting in Baltimore, Celltrion Healthcare today advocated for healthcare systems to introduce biologics earlier in a patient’s treatment regimen in order to improve clinical outcomes. Several studies show that the early introduction of biologics can bring …

Read More »

FDA Approves Pfizer’s Retacrit, the First Epoetin Alfa Biosimilar for the Treatment of Anemia

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) approved RETACRIT® (epoetin alfa-epbx), a biosimilar to Epogen® and Procrit® (epoetin alfa)1, for all indications of the reference product. RETACRIT is now the first and only biosimilar erythropoiesis-stimulating agent (ESA) to be approved in the U.S. “As …

Read More »

Sandoz Receives Complete Response Letter from the FDA for Proposed Biosimilar Rituximab

Holzkirchen, May 2, 2018 – Sandoz, a Novartis division, announced today that the US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the Biologics Licensing Application (BLA) for its proposed biosimilar rituximab. Sandoz stands behind the robust body of evidence included in the regulatory submission and …

Read More »

FDA Requests Additional Information for Pfizer’s Application for its Proposed Trastuzumab Biosimilar

NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) today announced that it received a Complete Response Letter (CRL) from the United States Food and Drug Administration (FDA) in response to the Biologics License Application for the company’s proposed trastuzumab biosimilar. In the CRL, the FDA highlighted the need for additional technical information. The …

Read More »