10 Ways To Speed Up CMC In Early-Stage Drug Product Development The inherent complexity of living cell-based products, vector-based gene therapies, and highly sensitive analytical methods demands robust change management strategies. Challenges And Opportunities Of Outsourcing Biopharma Development ...
Biosimilar drug products are recombinant, cellderived protein products whose safety, identity, purity, impurities, potency, and quality can be determined, monitored, and controlled. These products are comparable in quality, safety, and efficacy to their corresponding innovative biotechnologyderived product(...
To be approved as a biosimilar, a drug must be highly similar to the original biological drug—in this case, trastuzumab. And in terms of safety, purity, and potency, there can be no clinically meaningful differences between the biosimilar and the original product, which FDA calls the referenc...
A biosimilar is not considered a “generic” in the same way that a traditional, small molecule drug (for example: ibuprofen or acetaminophen) is determined to be a generic. Biosimilars are "similar" because they are biologics that do not have to be exact copies of the active ingredient, as...
As biosimilar development is expected to accelerate over the next decade, many customers are seeking packaging recommendations for these drug products. Because biosimilars are extremely sensitive to any changes from the innovator’s manufacturing and packaging processes, in every case it ...
Biosimilar drug products must have a demonstrated similarity with respect to the reference product’s molecules in order to ensure both the effectiveness of the drug and the patients’ safety. In this paper the fusion framework of a highly sensitive NMR
One of the first major hurdles in biosimilar development is the regulatory landscape. Different regions have varying requirements, and the approval process can be lengthy and complex. FDA vs. EMA: A Tale of Two Agencies The U.S. Food and Drug Administration (FDA) and the European Medi...
Leading biosimilar drug companies - see what they're doing, including their outlooks In particular our survey analyses 25 leading biosimilar specialists, including these firms: Sandoz Teva Pharmaceutical Industries Hospira Celltrion LG Life Sciences ...
Biosimilar Drug Profile: Amjevita is an FDA-approved biosimilar version of adalimumab (reference product, Humira®, Abbvie). Originally known as ABP 501, Amgen submitted a biologic license application for approval via the 351(k) biosimilar pathway in November 2015. The Food and Drug ...
This drug was launched in January 2020.About the ManufacturerPfizer entered the biosimilar market through two avenues: (1) its acquisition of Hospira and (2) its own internal pipeline development. Pfizer was established in 1849, and it is headquartered in New York City. It has a considerable ...