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September 28, 2018
Specialist biopharmaceutical company, Alvotech, has announced receipt of a manufacturing license from the Icelandic Medicines Agency, applying to its biopharmaceutical facility based in Reykjavik, Iceland.
While food, shelter, and clothing are the primal essentials for life, hope-as embodied by modern medicine-has now become part of that human expectation.
September 27, 2018
The company’s biosimiliar to Amgen’s Neulasta (pegfilgrastim) received a positive opinion for marketing authorization from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
September 13, 2018
The collaboration will focus on developing manufacturing solutions for biosimilars.
September 10, 2018
FDA, innovator companies, and biosimilar developers maneuver over exclusivity, naming, interchangeability, and more.
August 29, 2018
Protagen Protein Services, a CRO, now offers quicker and more accurate characterization of biomolecular stability using differential scanning calorimetry (DSC).
August 28, 2018
Preliminary survey results rank the United States, Germany, and Japan as tier-one nations for bioprocessing performance and potential.
August 14, 2018
Drug product approval from FDA follows previous approvals from European and Japanese authorities.
August 07, 2018
The European Commission (EC) approved Pfizer’s Trazimera (trastuzumab), a biosimilar to Roche’s Herceptin, to treat certain breast and gastric cancers.
August 02, 2018
Frustrated by slow market adoption, Gottlieb maps out new plan for biosimilar competition.