Tag Archives: biosimilar

FDA Approves Nyvepria (pegfilgrastim-apgf), a Biosimilar to Neulasta

FDA Approves Nyvepria (pegfilgrastim-apgf), a Biosimilar to Neulasta Print this page NEW YORK–(BUSINESS WIRE)– June 11, 2020 — Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Nyvepria (pegfilgrastim-apgf), a biosimilar to Neulasta® (pegfilgrastim).1 Nyvepria is indicated to decrease the incidence of infection, as manifested by febrile… Read More »

FDA Approves Avsola (infliximab-axxq), a Biosimilar to Remicade

FDA Approves Avsola (infliximab-axxq), a Biosimilar to Remicade Print this page THOUSAND OAKS, Calif., Dec. 6, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Avsola (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn’s… Read More »

Novartis’s Sandoz licenses proposed multiple sclerosis biosimilar

ZURICH (Reuters) – Swiss drugmaker Novartis’s Sandoz division has licensed from Polpharma Biologics a proposed biosimilar version of multiple sclerosis drug natalizumab, the companies said on Tuesday without giving financial details of the accord. The medicine is in Phase III clinical development for the treatment of relapsing-remitting multiple sclerosis (RRMS). Polpharma Biologics will develop, manufacture… Read More »

FDA Approves Kanjinti (trastuzumab-anns), a Biosimilar to Herceptin

FDA Approves Kanjinti (trastuzumab-anns), a Biosimilar to Herceptin Print this page THOUSAND OAKS, Calif., June 13, 2019 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Kanjinti (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant… Read More »

FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin

Home News New Drugs FDA Approves Ontruzant (trastuzumab-dttb), a Biosimilar to Herceptin Print this page January 18, 2019 — FDA today approved Ontruzant (trastuzumab-dttb), a biosimilar to U.S.-licensed Herceptin (trastuzumab). A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product,… Read More »

Novartis abandons effort for U.S. approval of biosimilar rituximab

FILE PHOTO: Swiss drugmaker Novartis’ logo is seen at the company’s plant in the northern Swiss town of Stein, Switzerland October 23, 2017. REUTERS/Arnd Wiegmann/File Photo (Reuters) – Novartis International AG said on Friday that its Sandoz division is abandoning an effort to gain U.S. regulatory approval for a biosimilar of rituximab, a medication used… Read More »