An increase in therapies targeting smaller niche segments of the market rather than blockbuster drugs for large patient populations is creating new pressures on biomanufacturers to meet patient needs. This eBook contains solutions and strategies to consider for faster and more flexible, cost-effective approaches to drug development and manufacturing. Download the full eBook to get access to the following articles and more.
By Anna Rose Welch, chief editor, Biosimilar Development
In this Q&A, HoUng Kim, head of the Medical and Marketing Division at Celltrion Healthcare, shares the biggest market-related considerations and regulatory challenges facing a biosimilar company exploring both biosimilars and bioinnovative products.
By John Bennett, Brian Drummond, and Kline Moore, Goodwin
The Federal Circuit recently issued Rule 36 judgments in two separate BPCIA cases: Genentech v. Amgen and Janssen v. Celltrion. This two-part article series explores some of the unanswered questions raised in these two cases. In Part 1, Genentech v. Amgen was discussed. Here, Part 2 delves into the remaining questions following Janssen v. Celltrion.
In the U.S., it is estimated that biosimilars can save the healthcare system approximately $150 billion over the next five to 10 years. In this op-ed, Amgen's Chad Pettit shares why the U.S. has cause to be optimistic about the competition emerging in the U.S.
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By Omar A. Salman, Ph.D.,Pfizer CentreOne Contract Manufacturing
Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing.
By Nathan Sepulveda, et. al.,Bio-Rad Laboratories, Inc.
This poster explains how Bio-Rad’s QXDx™ BCR-ABL %IS Kit quantifies the amount of BCR-ABL1 transcript as a ratio of BCR-ABL1/ABL1 then returns the value of molecular response (MR) on the WHO international scale(IS).
Bolt Biotherapeutics CMO, Dr. Edith Perez, and VP of CMC & Quality, Dr. Nathan Ihle, bring patient and production process expertise to the table for a conversation with Business of Biotech on preparing chemistry, manufacturing, and controls (CMC) for an IND and ensuing first-in-human studies. Listen now and subscribe so you never miss an episode.