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Biosimilars

FDA Committee Recommends Approval of Mylan and Biocon’s Proposed Biosimilar Trastuzumab

HERTFORDSHIRE, England and PITTSBURGH and BENGALURU, India, July 13, 2017/PRNewswire/ — Mylan N.V. (NASDAQ, TASE: MYL) and Biocon Ltd. (BSE code: 532523, NSE: BIOCON) today announced that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the companies’ proposed biosimilar trastuzumab. The committee voted 16-0 in support of eligible …

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Celltrion and Teva Announce FDA Acceptance of BLA for Proposed Biosimilar to Rituxan

INCHEON, South Korea & JERUSALEM–(BUSINESS WIRE)–Celltrion, Inc., a global biopharmaceutical company, and Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for CT-P10, a proposed Monoclonal Antibody (mAb) biosimilar to Rituxan®1 (rituximab), …

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FDA Rejects Pfizer’s BLA for Proposed Epoetin Alfa Biosimilar

NEW YORK, N.Y., June 22 – Pfizer Inc. (NYSE:PFE) today announced that it has received a Complete Response Letter (CRL) from the United States (U.S.) Food and Drug Administration (FDA) regarding the company’s Biologics License Application (BLA) for its proposed epoetin alfa biosimilar. This CRL relates to matters noted in …

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Results from Late-Stage Study Demonstrate Clinical Equivalence of Boehringer Ingelheim’s Adalimumab Biosimilar Candidate to Humira

Ingelheim/Germany and Madrid/Spain, June 14, 2017 – Boehringer Ingelheim announced today results from the pivotal Phase III VOLTAIRE®-RA1  study, confirming that its adalimumab biosimilar candidate BI 695501 and HUMIRA®* have similar efficacy, safety and immunogenicity in patients with moderately-to-severely active rheumatoid arthritis. The 24 week results will be presented at …

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AAM Biosimilars Council Praises Supreme Court Ruling that will Accelerate Patient Access to Biosimilars

WASHINGTON–(BUSINESS WIRE)–The Association for Accessible Medicines (AAM) applauded the U.S. Supreme Court’s decision this week in Sandoz Inc. v. Amgen Inc. that will help speed patient access to biosimilar versions of expensive brand-name biologic medicines. In a unanimous ruling, the Court overturned a lower court decision that had effectively extended …

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FDA Rejects Coherus’ Application for Proposed Biosimilar to Amgen’s Neulasta

REDWOOD CITY, Calif., June 12, 2017 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ:CHRS), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter (“CRL”) for its biologics license application (“BLA”) for CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate, under the 351(k) pathway. The CRL primarily …

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FDA Advisory Committee to Review Amgen and Allergan’s Biosimilar Candidate to Bevacizumab

THOUSAND OAKS, Calif., June 7, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) and Allergan plc. (NYSE: AGN) today announced that the Oncologic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) will review data supporting the Biologics License Application (BLA) for ABP 215, a biosimilar candidate to Avastin® (bevacizumab), …

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FDA Panel Recommends Approval of Pfizer’s Epoetin Alfa Biosimilar Across All Indications

Pfizer Inc. (NYSE:PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the Company’s proposed epoetin alfa biosimilar across all indications. This marks the first time a biosimilar erythropoiesis-stimulating agent (ESA) has been recommended for approval by a U.S. FDA …

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Cinfa’s Pegfilgrastim Biosimilar Candidate Demonstrates Positive Results in Second Clinical Study

PAMPLONA, Spain | May 17, 2017 | Cinfa Biotech S.L., the biosimilars company of Cinfa Group, today announced positive top-line data from the second clinical trial with its lead development candidate B12019, a biosimilar version of Neulasta(R)(pegfilgrastim) to treat chemotherapy-induced neutropenia. The trial demonstrated comparability of B12019 and its reference product Neulasta …

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WHO to Begin Pilot Prequalification of Biosimilars for Cancer Treatment

4 MAY 2017 | GENEVA – This year WHO will launch a pilot project for prequalifying biosimilar medicines, a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income countries. In September, WHO will invite manufacturers to submit applications for prequalification of …

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